63578 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 807

[Docket No. 91N–0295]

RIN 0910–AA09

Medical Devices; Medical Device User

Facility and Manufacturer Reporting,

Certification and Registration

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; opportunity for

comments.

SUMMARY: The Food and Drug

Administration (FDA) is issuing

regulations requiring medical device

user facilities and manufacturers to

report adverse events, related to medical

devices, under a uniform reporting

system. This regulation is mandated by

the Safe Medical Devices Act of 1990

(SMDA) and prescribes the conditions

under which reports must be submitted,

the content and timing of the requisite

reports, and how FDA will utilize the

information in carrying out its public

health protection responsibilities. This

rule is intended to augment the agency’s

postmarket surveillance activities and

public health protection responsibilities

relating to medical devices.

In the future, FDA will propose to

revoke the distributor adverse event

reporting regulations that went into

effect on May 28, 1992, by operation of

law and replace them with provisions

based on notice and comment. FDA will

also propose to fully implement its

authority under the Medical Device

Amendments of 1992 (the 1992

amendments).

DATES: This final rule is effective April

11, 1996. Submit written comments, as

requested elsewhere in this document

by, January 10, 1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Earl

W. Robinson, Center for Devices and

Radiological Health (HFZ-530), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301–594–

2735.

SUPPLEMENTARY INFORMATION: On

November 26, 1991 (56 FR 60024), FDA

published a tentative final rule

implementing the user and distributor

reporting provisions of the SMDA

(hereinafter referred to as the November

1991 tentative final rule). The agency

received over 300 comments in response

to the tentative final rule, which are

carefully evaluated and responded to in

this final rule. The final rule also

reflects the superseding reporting

standard mandated by the Medical

Device Amendments of 1992.

I. Highlights of the Final Rule

This final rule provides FDA with

increased post-market surveillance

information by requiring medical device

user facilities and manufacturers to

report adverse event information as

follows:

(a) Medical device user facilities must

submit a medical device report (MDR) to

the device manufacturer within 10 days

after becoming aware of a reportable

death or serious injury (including

serious illness). If the event involves a

device-related death, or if the identity of

the device manufacturer is not known,

the report must be sent to FDA. User

facilities must also submit a semiannual

summary of reports to FDA.

(b) Device manufacturers must submit

MDR reports to FDA within 30 days

after becoming aware of a reportable

death, serious injury, or malfunction.

(c) Device manufacturers must

annually certify the number of MDR

reports filed with FDA during the

preceding year.

(d) Upon receiving information about

an MDR reportable event, device

manufacturers must submit a ‘‘5-day

report’’ to FDA, within 5 work days of:

(1) Becoming aware that a reportable

event or events, from any information,

including any trend analysis,

necessitates remedial action to prevent

an unreasonable risk of substantial harm

to the public health; or (2) becoming

aware of an MDR reportable event from

which FDA has made a written request

for the submission of a 5-day report.

(e) A device manufacturer is

responsible for reporting MDR events

related to its devices, whether or not the

devices are still being marketed by the

firm. If a manufacturer receives

information about an event involving a

device incorrectly identified as one

marketed by that firm, the information

received must still be forwarded to FDA,

with an explanation that the device was

misidentified.

In finalizing this regulation, FDA has

worked to meet the significant

challenges of devising an effective

medical device adverse event reporting

system while balancing industry

concerns with public health needs and

statutory imperatives. The agency has

also taken steps to minimize the

administrative costs and paperwork

burdens that will inevitably result for

FDA, the medical device industry, and

the device user community. FDA is

keenly aware of and sensitive to the

impacts of these new regulatory

requirements on the pace of

technological advancement and

economic well-being of the medical

device industry. At the same time, the

agency is cognizant of the usefulness of

information about the clinical

performance of medical devices in

fulfilling its public health mandate.

In striving to achieve regulatory

balance, the agency carefully analyzed

over 300 public comments submitted in

response to the November 1991

tentative final rule, and resolved policy

and legal issues arising from the

comments and internal deliberations.

This review of comments, combined

with an economic threshold analysis,

and other agency studies and

deliberations, resulted in a number of

major modifications that will facilitate

compliance with the final reporting

requirements and substantially reduce

the overall costs, by an estimated $31

million, borne by device user facilities,

the device industry, and the agency.

These modifications are as follows:

(a) The agency has eliminated certain

criteria from the previously proposed

manufacturer monthly reports

including: An evaluation consisting of a

narrative description of the results of

statistical trend analyses conducted by

the manufacturer, a discussion of the

underlying methodologies used, a

description of any unusual or

unexpected events, and a description of

any remedial actions taken.

FDA believes that the benefits of the

proposed mandatory trend analyses

were not commensurate with the

attendant costs to industry. Upon

further review, the agency has

determined that it would incur the costs

of data entry regardless of the industry’s

analysis, and operating a computer

program for the analysis of the data

would be a relatively low cost to the

agency. The proposed requirements for

other information that the final

regulation is not adopting will still be

made available to the agency under the

existing current good manufacturing

practice (CGMP) regulations (21 CFR

part 820), and under proposed 21 CFR

part 806, reports of removals and

corrections (59 FR 13828, March 23,

1994).

(b) The final regulation’s reporting

timeframe is shorter than the timeframe

proposed. Earlier access to adverse

event information will help the agency

better to protect the public health.

(c) The agency has eliminated the

proposed training and educational

requirements, which would have been

particularly costly to user facilities,
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63579

because the projected costs substantially

exceeded expected benefits. This change

will provide a net estimated annual cost

saving of $29.1 million.

(d) The proposed imminent hazard

report deadline has been extended from

3 days to 5 days, and renamed a 5-day

report. This extended reporting

timeframe should provide a more

realistic opportunity for the

manufacturer to conduct a preliminary

investigation regarding the event. Any

information not available for submission

on the 5-day report must be submitted

in a supplemental report.

(e) The agency has developed

reporting forms for baseline reports,

semiannual reports, and annual

certifications. This action will

streamline the reporting procedure

because industry will not be required to

format its own reports. The

standardized report forms and

associated standardized electronic

reporting formats will facilitate the

input of information submitted into

FDA’s data base. This more efficient

data processing will increase the

agency’s capacity to respond to critical

device- related problems by permitting

more rapid data analysis, leading to

appropriate corrective measures.

(f) The agency has adapted its MDR

systems and reporting requirements in

order to use the MEDWATCH form for

reporting individual adverse events. In

so doing, FDA has eliminated a number

of proposed reporting elements,

including the ‘‘degree of certainty’’

associated with a reportable event, the

‘‘medical status of patients’’ involved in

device-related incidents, product

‘‘service and maintenance,’’ etc. The

adoption of the MEDWATCH reporting

form streamlines the reporting process

and reduces the amount of information

reporters must submit to FDA.

(g) The agency has clarified that user

facilities must report only information

that is reasonably known to them, and

are not required to investigate adverse

events.

(h) The agency has devoted much

time and effort to accommodate

electronic reporting. The agency is in

the process of developing formats,

guidelines, and procedures for

electronic reports which, when

available, will obviate the need for

written agency approval for the use of

electronic submissions.

(i) In response to comments, the

agency has clarified a number of the

definitions included in the proposed

rule and added new definitions to

enhance clarity. The agency also

substantially altered the organization

and the paragraph designations of the

final rule to provide information in the

clearest and most usable form in part

803 (21 CFR part 803).

Revised part 803 has been subdivided

into five subparts. Subpart A contains

general provisions including sections

for the scope, definitions, public

availability of reports, and general

reporting and record requirements.

Subpart B of revised part 803 contains

generally applicable reporting

requirements for individual adverse

event reports. Specific requirements for

individual adverse event reports, and

other reports required by user facilities

and manufacturers, are in subparts C

and E, respectively. Each subpart

divides the reporting requirements for

each type of reporting entity into

separate sections that are organized to

improve readability. The agency

believes that the new organization of the

regulation provides clearer guidance to

industry than the 1991 tentative final

rule.

II. Background

Under the Federal Food, Drug, and

Cosmetic Act of 1938 (21 U.S.C. 301–

394) (the act), and the Medical Device

Amendments of 1976 (Pub. L. 94–295)

(the 1976 amendments), FDA issued

medical device reporting regulations for

manufacturers (49 FR 36326 at 36348,

September 14, 1984). To correct

weaknesses noted in the 1976

amendments, and to better protect the

public health by increasing reports of

device-related adverse events, Congress

enacted the SMDA (Pub. L. 101–629),

which required medical device user

facilities, and distributors to report

certain device-related adverse events. In

response to a directive in the SMDA,

FDA issued the November 1991

tentative final rule proposing to

implement regulations concerning

reporting of adverse events related to

devices by user facilities and

distributors. In the November 1991

tentative final rule, FDA also proposed

to amend the existing manufacturer

reporting regulations to conform to the

proposed user facility and distributor

reporting requirements.

A. User Facility, Manufacturer and

Distributor Reporting Requirements

Under the SMDA

The SMDA added section 519(b)(1) to

the act (21 U.S.C. 360i(b)(1)) to require

that certain user facilities (hospitals,

nursing homes, ambulatory surgical

facilities and outpatient treatment

facilities) report certain adverse events.

The SMDA also authorized FDA to

require diagnostic outpatient facilities to

submit reports. Under the SMDA, user

facilities must report device-related

deaths to FDA and to the manufacturer.

They must also report serious illnesses

and injuries to the manufacturer, or to

FDA if the manufacturer’s identity is

unknown. Reports must be made as

soon as practicable, but no later than 10

working days after the user facility

becomes aware of a reportable event. In

addition to individual adverse event

reports, the SMDA requires each user

facility to submit to FDA, on a

semiannual basis, a summary of the

reports it has submitted to FDA and to

manufacturers. The provision in section

519(b) of the act that requires user

facilities to report adverse events

became effective by operation of law on

November 28, 1991.

In addition to requiring reporting by

user facilities, the SMDA added section

519(a)(6) (subsequently redesignated as

519(a)(9) by the 1992 amendments) to

the act to require FDA to issue

regulations regarding distributor

reporting of adverse device events. The

SMDA also added section 519(d) to the

act to require both manufacturers and

distributors to certify to FDA either the

number of reports submitted in a year or

that no such reports were submitted to

the agency.

Distributor reporting requirements

became effective on May 28, 1992, when

the provisions relating to distributor

reporting in the November 1991

tentative final rule became final by

operation of law. In the Federal Register

of September 1, 1993 (58 FR 46514),

FDA published a notice announcing that

the proposed distributor reporting

regulations had become final by

operation of law on May 28, 1992, and

that these regulations had been

amended by certain provisions of the

1992 amendments discussed below.

In the Federal Register of September

1, 1993, FDA also published a final rule,

based on the November 1991 tentative

final rule, requiring distributors to

register and list their devices (58 FR

46514). Distributor registration and

listing requirements became effective on

October 1, 1993.

In a future rulemaking, FDA will

propose in the Federal Register to

revoke the distributor regulation that

went into effect by operation of law and

replace it with provisions based on

notice and comment.

B. User Facility, Manufacturer and

Distributor Reporting Requirements

Under the Medical Device Amendments

of 1992

Subsequent to FDA’s issuance of the

November 1991 tentative final rule to

require adverse event reporting by user

facilities, distributors, and

manufacturers, on June 16, 1992, the

President signed into law the 1992
63580 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

amendments (Pub. L. 102–300),

amending certain provisions of section

519 of the act relating to reporting of

adverse device events. In the future,

FDA will publish a proposed rule to

fully implement its authority under the

1992 amendments. A summary of these

changes follows:

1. Adoption of a Single Reporting

Standard

Section 5(a) of the 1992 amendments

adopts a single standard to specify when

injuries caused by devices must be

reported to FDA. Manufacturers and

importers are required to report a

device-related adverse event to FDA

whenever they receive or otherwise

become aware of information that

reasonably suggests that one of their

marketed devices may have caused or

contributed to a death or serious injury,

or has malfunctioned and that such

device or a similar device marketed by

them would be likely to cause or

contribute to a death or serious injury if

the malfunction were to recur.

Similarly, section 5(a) of the 1992

amendments revises the reporting

requirements to require a user facility to

report whenever the facility receives or

otherwise becomes aware of information

that reasonably suggests that a device

‘‘has or may have caused or

contributed’’ to the death, serious

illness or serious injury of a patient of

the facility.

2. Single Definition of Types of Injuries

That Must Be Reported

Section 5(a) of the 1992 amendments

also adopted a single definition for the

types of injuries that user facilities,

manufacturers, importers, and

distributors must report. This definition

requires reporting of an injury or illness

that is: (1) Life-threatening; (2) results in

permanent impairment of a body

function or permanent damage to a body

structure; or (3) necessitates medical or

surgical intervention to preclude

permanent impairment of a body

function or permanent damage to a body

structure. This definition differs from

the previous statutory definition of

‘‘serious injury’’ or ‘‘serious illness’’ in

the user facility provisions and the

definition in the November 1991

tentative final regulation. The new

definition deleted the requirement that

an injury must require immediate

intervention to preclude permanent

impairment or damage in order to

qualify as a reportable adverse event.

3. New Authority To Require Reporting

of ‘‘Other Significant Adverse Device

Experiences’’

The 1992 amendments also

authorized FDA to issue regulations

requiring user facilities, manufacturers,

importers, and distributors to report

‘‘significant adverse device

experiences’’ that the agency determines

are necessary to be reported, other than

deaths, serious injuries or serious

illnesses, that might otherwise not fall

within the definitions of reportable

deaths, serious injuries, or

malfunctions.

III. Reporting Forms

A. Individual Adverse Event Reports by

User Facilities and Manufacturers

Under §§ 803.30 and 803.50, user

facilities and manufacturers are required

to submit device-related reports of

individual adverse events on FDA Form

3500A or an FDA approved electronic

equivalent. In order to simplify and

consolidate reporting of adverse events,

FDA announced in the Federal Register

of February 26, 1993 (58 FR 11768) the

availability of a new single

‘‘MEDWATCH’’ form for reporting

adverse events and product problems

with devices, drugs, biologics, special

nutritional products and other products

regulated by the agency (hereinafter

referred to as the February 1993 notice).

In response to FDA’s request for

comments on the form in the Federal

Register, 79 comments were submitted

by medical device trade associations

and other regulated or affected entities.

On June 3, 1993 (58 FR 31596), after

consideration of these comments, FDA

published the final reporting form. (The

form is described in § 803.10.)

B. Annual Certification by

Manufacturers

Under § 803.57, manufacturers must

also submit at the time of their annual

registration a completed FDA Form

3381 or an FDA approved electronic

equivalent, certifying: (1) That all

reportable events were submitted; (2)

the number of reports submitted; or (3)

that no reports were submitted during

the previous 12-month period.

C. Semiannual Summaries by User

Facilities

Under § 803.33, user facilities are

required to submit, on FDA Form 3419

or an FDA approved electronic

equivalent, a semiannual summary of all

events reported during the prior

reporting period. Semiannual reports

must include information regarding the

user facility, device manufacturers,

products, and a brief description of the

events.

D. Baseline Reports

Under § 803.55, manufacturers must

submit baseline reports, on FDA Form

3417 or an FDA approved electronic

equivalent, simultaneously with the

submission of the first event report for

each device. These reports, which are to

be updated annually, must contain

information on the manufacture and

distribution of the relevant devices.

E. Effective Date of the Reports

Adverse event reports and other

related reports required by this

regulation must be submitted using the

appropriate forms or approved

electronic equivalents, after April 11,

1996.

IV. Summary and Analysis of

Comments and FDA’s Response

This final rule is based on FDA’s

analysis of the over 300 comments that

the agency received in response to the

November 1991 tentative final rule, and

it conforms to certain statutory revisions

in the 1992 amendments. This final rule

reflects actions in two areas. First, it

revises the manufacturer reporting

regulations that have been in effect

since 1984. Second, it implements the

statutorily directed user facility

reporting requirements that have been

in effect since November 28, 1991.

Originally, FDA gave interested

persons until January 27, 1992, to

comment on the November 1991

tentative final rule. In the Federal

Register of January 24, 1992 (57 FR

2861), FDA extended the comment

period until February 26, 1992. A

summary of the comments and FDA’s

responses follow:

A. Section 803.1—Scope

1. Several comments stated that the

proposed regulation exceeds the SMDA

and has no statutory authority. Many

comments stated that the scope of the

provisions was overly broad, and would

increase the burdens, with unclear

benefits, on all parties involved.

The agency disagrees. Section 519 of

the act, as amended by the SMDA and

the 1992 amendments, provides clear

authority to issue this regulation.

Section 519 of the 1976 amendments

granted FDA the authority to issue

regulations to require manufacturers to

maintain such records, make such

reports, and provide such information to

FDA as may reasonably be necessary to

ensure that devices are not adulterated

or misbranded and are otherwise safe

and effective for human use. The

legislative history of the 1976
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63581

amendments reflects clear congressional

intent to permit FDA to require, under

the authority of section 519 of the act,

manufacturers to report to FDA product

defects and adverse effects of the firms’

devices. (See H. Rept. 853, 94th Cong.,

2d Sess. 23 (1976).)

Among other things, section 519 of

the act states that any reporting

requirement established under the

authority of that section: (1) May not be

unduly burdensome (considering the

cost of compliance and the need for the

requirement); (2) shall state the purpose

for any required report or information

and identify to the fullest extent

practicable such report or information;

(3) may not, except in certain

circumstances, require the disclosure of

a patient’s identity; and (4) may not,

except in certain circumstances, require

the manufacturer of a class I device to

maintain records or to submit

information not in its possession, unless

such report or information is necessary

to determine whether a device is

misbranded or adulterated. The House

Report cautions, however, that these

limitations ‘‘should not be construed as

limiting the Secretary’s authority to

obtain information needed to insure that

the public is protected from potentially

hazardous devices.’’ (Id.) In its

discussion of section 519 of the act, the

House Report lists examples of

reasonable reporting requirements,

including reports of defects, adverse

reactions and patient injuries. It is also

clear from the legislative history that

Congress intended FDA to use its

authority under section 519 of the act to

protect the public from potentially

hazardous devices, as well as from

devices with confirmed hazards. (Id.)

Since enactment of the 1976

amendments, Congress has focused

considerable attention on FDA’s

implementation and enforcement of the

act. Congress concluded that the 1976

amendments were not always adequate

to protect the public health. (H. Rept.

808, 101st Cong., 2d Sess. 13–14 (1990);

S. Rept. 513, 101st Cong., 2d Sess. 13–

16 (1990).) To correct these problems,

Congress passed and the President, on

November 28, 1990, signed into law the

SMDA, which amended the medical

device provisions of the act.

The SMDA added section 519(b)(1) to

the act to require that certain user

facilities (e.g., hospitals, nursing homes,

ambulatory surgical facilities, and

outpatient treatment facilities) report

deaths related to medical devices to

FDA, as well as to the manufacturer if

the manufacturer’s identity is known.

Section 519(b)(5)(A) of the act also

provides FDA with authority, which

FDA has exercised in this final

regulation, to include outpatient

diagnostic facilities in this requirement.

Serious illnesses and injuries are to be

reported to the manufacturer, or to FDA

if the manufacturer’s identity is not

known. Reports must be made as soon

as practicable but no later than 10

working days after the user facility

becomes aware of an event. The

responsibility for reporting is limited to

events involving patients and

employees of the facility. Each device

user facility is also required to submit

to FDA, on a semiannual basis, a

summary of reports it has submitted to

both FDA and manufacturers.

Section 519(d) of the act, as added by

the SMDA, also requires manufacturers

to certify to FDA the number of reports

submitted in the preceding 12-month

period or, alternatively, certify that no

such reports have been submitted to the

agency during the same period. FDA

believes that section 519 of the act, as

amended by the SMDA and the 1992

amendments, provides clear authority to

issue this regulation for manufacturers

and user facility reporting.

Moreover, FDA does not believe that

the provisions of this regulation are

overly broad or unduly burdensome.

FDA has reviewed and revised the

regulation to clarify and limit the scope

as appropriate. FDA believes that

certain classes of persons, which might

otherwise fit within the definition of

manufacturer, should be exempt from

the reporting requirements because

reports from these persons are not

necessary to ensure that the device is

not adulterated or misbranded, and the

device is otherwise safe and effective.

Accordingly under § 803.19, dental

laboratories and optical laboratories

have been exempted from the reporting

requirements. FDA believes that these

entities are not likely to receive reports

of device-related deaths, serious

injuries, or reportable malfunctions. In

addition, requiring negative annual

certification reports from these entities

would be burdensome and not provide

significant benefit to the public health.

Therefore, FDA is excluding such

entities from the reporting requirements.

Other specific revisions are discussed in

detail throughout this document.

FDA believes this regulation carefully

balances the interests of public health

with industry burdens by limiting the

required information to only that which

is necessary to evaluate risks associated

with medical devices and that it will

enable the agency better to take

appropriate regulatory measures to

protect the public health. Furthermore,

FDA does not believe that the burden on

reporting entities will be significant.

Based upon the number of reports FDA

has received since the publication of the

November 1991 tentative final rule, the

agency anticipates that it will receive

approximately 150,000 reports the first

year of this reporting program (the

agency currently receives over 100,000

reports annually).

2. Several comments pointed out that

these provisions go beyond the scope of

the SMDA in that the timeframes for

reporting adverse events exceed the

requirements of SMDA. Other

comments argued that all employees of

reporting entities should not be

included under the reporting

requirements of the SMDA, and that

accordingly, the timeframes for

reporting should not be triggered upon

the knowledge of ‘‘any employee’’ of a

reporting entity.

FDA does not agree that the

regulation’s 10-day reporting timeframes

for user facilities and 5-day and 30-day

reporting timeframes for manufacturers

are beyond the scope of the SMDA.

Section 519(b)(1)(A) of the act specifies

that user facilities must report certain

adverse events as soon as practicable,

but not later than 10 work days after

becoming aware of the information. This

section further specifies that FDA has

the discretion to prescribe, by

regulation, a shorter reporting period.

While the statute does not specify the

time periods allowed to manufacturers,

the timeframes are consistent with

section 519 of the act, the legislative

history and FDA’s public health

responsibility to require that the reports

are forwarded to the agency in a timely

manner. FDA believes the time periods

prescribed in the final regulation allow

sufficient time for reporting entities to

gather information, and are sufficiently

time sensitive to allow the agency to

respond rapidly and appropriately to

protect the public health.

FDA also does not agree that

employees of reporting entities should

not be subject to the reporting

requirements and that timeframes for

reporting should not be triggered when

employees of the reporting entities

become aware of events. The scope of

the act does not exclude any responsible

persons who are employees of these

entities from complying with section

519 of the act.

Under the final regulation, the

reporting periods are based upon the

time at which the reporting entity

becomes aware of the reportable event.

FDA believes that the final regulation’s

definition of ‘‘becomes aware’’ in

§ 803.3(c) properly defines the types of

user facility and manufacturer

employees who must become aware of

a reportable event in order to trigger the

reporting requirement. FDA believes
63582 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

that it will be feasible for user facilities

and manufacturers to train the

employees, described below, to be

familiar enough with the obligation to

report adverse events immediately to

the appropriate person that the

manufacturer or user facility designates

as responsible for MDR reporting.

Under § 803.3(c), a device user facility

is deemed to have ‘‘become aware’’

when medical personnel of a facility

become aware of a reportable event.

‘‘Medical personnel’’ are defined in

§ 803.3(r) as individuals who are

licensed, registered, or certified to

administer health care; individuals with

professional or scientific degrees;

individuals who are responsible for

receiving medical complaints or adverse

event reports; or supervisors of such

persons. FDA believes that a user

facility can easily notify these types of

employees about their obligation to

immediately forward possible devicerelated adverse events to the appropriate

person designated by the hospital to

submit such reports.

FDA believes that manufacturers have

a direct responsibility to inform all

employees to immediately forward

adverse event information to the

appropriate person appointed by those

entities to submit MDR reports.

Accordingly, FDA generally considers

that a manufacturer becomes aware of

an adverse event whenever any

employee becomes aware of an adverse

event. The one exception is for 5-day

reports under § 803.53(b), which

requires manufacturers to submit a

report when the manufacturer becomes

aware of information that an adverse

event or events necessitate remedial

action to prevent an unreasonable risk

of substantial harm to the public health.

Under § 803.53, manufacturers must

submit a 5-day report under two

different circumstances. The first type of

5-day reporting obligation arises after a

manufacturer has received a written

request from FDA for 5-day reports for

specific types of adverse events. Under

this circumstance, a 5-day report must

be submitted when any employee

becomes aware of an adverse event.

FDA believes that the awareness of any

employee should trigger the reporting

requirement when FDA has informed

the manufacturer of the need for specific

adverse events that require 5-day reports

because the manufacturer could easily

inform all of its employees of FDA’s

request.

The second type of 5-day report does

not involve a direct request from FDA

and is required only when the

manufacturer becomes aware that an

event or events necessitate remedial

action to prevent an unreasonable risk

of substantial harm to the public health.

Accordingly, this type of 5-day

reporting requirement would only arise

if remedial action were required, and

the remedial action is necessary to

prevent an unreasonable risk of

substantial harm to the public health. If

no remedial action is required, or the

remedial action is taken but it is not

necessary to prevent an unreasonable

risk to the public health, reportable

adverse events should be submitted as

30 day reports.

Because FDA does not believe certain

employees, such as non-technical staff,

would be able to recognize that an

adverse event or events may require

remedial action to prevent a substantial

risk to the public health, the final

regulation requires that these types of 5-

day reports be submitted only when

employees holding certain positions of

responsibility become aware of adverse

event information. Accordingly, the

final regulation considers a

manufacturer to be aware of this type of

5-day report only when an employee

with management or supervisory

responsibilities over persons with

regulatory, scientific, or technical

responsibilities, or a person whose

duties relate to the collection and

reporting of adverse events, becomes

aware that a reportable MDR event or

events necessitate remedial action to

prevent an unreasonable risk of

substantial harm to the public health.

FDA believes that limiting the type of

person who must be aware of the

adverse event to these types of

individuals is appropriate because

persons in these positions should be

able to recognize that the event or

events may present significant risks to

the public health.

3. Some comments suggested limiting

the scope of these provisions so that

reporting is required only when there is

a death or serious injury. Other

comments suggested that reports not be

required if the device was only

indirectly responsible for a death or

serious injury, or was not a significant

factor. Another comment suggested that

reporting be limited to instances of

malfunction.

Section 519 of the act provides FDA

with authority to require reporting of

adverse events other than deaths or

serious injuries. FDA has exercised this

authority since 1984 by requiring

manufacturers to report certain

malfunctions. Moreover, section

519(a)(1) of the act (as amended by

section 5 of the 1992 amendments)

specifically states FDA’s adverse event

reporting regulations must require

manufacturers to report malfunctions if

the recurrence of the malfunction would

be likely to cause a death or serious

injury, regardless of whether an actual

death or injury occurs. Because devices

with such malfunctions pose significant

risks, FDA needs to be informed of these

incidents. The final regulation,

therefore, requires manufacturers to

report malfunctions when recurrence

would be likely to cause a death or

serious injury. User facilities are

encouraged but not required to report

malfunctions to manufacturers and

distributors.

Section 519(b)(1)(B)(ii) of the act, as

added by the 1992 amendments, also

provides FDA with authority to require

user facilities, distributors, and

manufacturers to report other significant

adverse device experiences that FDA

determines necessary. Therefore, in a

future issue of the Federal Register,

FDA will propose to require that certain

events be reported as significant adverse

device experiences. Although some of

these experiences may not have caused

harm, FDA believes such events should

be reported because of the potential risk

to the public health if the event were to

recur. Such information will enable the

agency to take appropriate measures to

prevent such recurrences.

FDA also disagrees with the

comments stating that reporting should

be required only when a device directly

causes an adverse event or is a

significant factor. Section 519(a)(1) and

(b)(1)(A) of the act requires reporting of

any adverse event when information

reasonably suggests that a marketed

device ‘‘may have caused or

contributed’’ to a reportable event

(emphasis added). Limiting reporting to

adverse events directly or significantly

caused by devices would narrow the

statutory reporting standard which

requires reporting of adverse events

when a device ‘‘may have caused or

contributed’’ to an adverse event

(emphasis added).

FDA cannot agree with the comment

that suggested reporting be limited to

instances of malfunction. As stated

above, section 519 of the act requires

reporting of deaths and serious injuries,

and authorizes FDA to require reporting

of other significant adverse device

experiences, as well as malfunctions.

FDA does not agree with the

comments that reporting should not be

required when events are anticipated or

intrinsically caused by the device. The

statute does not exempt events that were

anticipated or intrinsically caused by

the device. (See section 519(a) (1) and

(b)(1)(B) of the act.) Moreover, merely

knowing that adverse events are

anticipated or intrinsically caused by a

device does not obviate the need for

information contained in event reports.
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63583

FDA needs to know the frequency and

severity of adverse events in order to

take appropriate action.

4. One comment objected to providing

warranty information. Other comments

stated that a manufacturer’s

responsibility to report should end at

the expiration of the warranty.

The agency disagrees. Reporting

requirements under section 519 of the

act are not restricted or limited in any

way by manufacturer warranties.

Section 519 of the act requires

manufacturers to report certain adverse

events regardless of whether the

warranty has expired. Warranties are

private contracts between the purchaser

and the manufacturer. In order to

protect the public health and determine

whether actions should be taken with

respect to a device associated with an

adverse event, FDA must receive

information regarding all reportable

events, including those that occur after

a manufacturer’s warranty has expired.

5. One comment stated that certain

adverse events may result from the user

not knowing how to properly use the

device, and that this would lead to the

reporting of events properly attributable

not to the device, but to its incorrect

use.

As with the 1984 manufacturer

adverse event reporting regulation, this

rule requires reports of certain adverse

device events caused by user error.

Device injuries attributed to user error

may indicate that the device is

misbranded within the meaning of

section 502(f) of the act (21 U.S.C.

352(f)) in that the device fails to bear

adequate directions for use or adequate

warnings. In such cases, reports of

adverse events that result from user

error may alert FDA to the need for

improved labeling to prevent future

injuries.

6. One comment suggested that

independent device service personnel

be added to the list of people required

to report because some manufacturers

may not receive reports from their own

service personnel.

Under section 519 of the act, only

user facilities, manufacturers, and

distributors are required to report

adverse events to FDA. User facilities

are considered to have ‘‘become aware’’

of such information whenever any

medical personnel becomes aware of a

reportable event. Manufacturers are

considered to have ‘‘become aware’’ of

events required to be reported in 30

days, or required to be reported in 5

days, pursuant to an FDA request, when

any employee becomes aware of an

adverse event. Manufacturers are

considered to have become aware of

significant risk 5-day reports, which are

more fully described in IV.A., comment

2, of this document, only when certain

higher level employees become aware of

adverse events requiring remedial

action.

FDA believes that an employee of a

manufacturer includes independent

service personnel who are contracted by

manufacturers to service their medical

devices. It is the responsibility of

manufacturers to ensure that their

service personnel, whether staff

employees or under contract, are

informed of the requirement to report

deaths, serious injuries, malfunctions,

or other significant adverse device

experiences that may be required by

regulation in the future.

B. Section 803.3—Definitions

7. Many comments stated that the

definition of ‘‘device family’’ (§ 803.3(e))

that is used to identify similar groups of

devices on the manufacturer baseline

report, is vague and overly broad. One

comment suggested that each device be

listed in the regulation; others suggested

that the definition be deleted.

FDA does not agree that the definition

should be deleted. The identification of

the device family on the baseline reports

for individual device models will help

FDA and manufacturers group similar

models for analysis. This will aid in

identifying the causation and nature of

device-related problems. FDA agrees,

however, that the definition should be

clarified and has revised it accordingly.

Manufacturers may use their own

methods of grouping devices if the

groupings meet the definition of ‘‘device

family,’’ i.e., the devices have the same

basic design and performance

characteristics related to safety and

effectiveness, intended use and

function, and device classification and

product code. FDA has the discretion to

determine the appropriateness of a

manufacturer’s determination of the

devices that comprise a device family. It

would be impractical to list each device

in the regulation.

8. Many comments stated that the

definition of ‘‘device user facility’’

(§ 803.3(f)) is vague. Several of these

comments requested clarification

regarding what facilities are included in

the definition. Several comments

suggested that certain groups (i.e., blood

banks, independent rescue squads,

school clinics or nurse offices, employee

health units, dental offices and freestanding care units operating as private

physician offices) be specifically

included or excluded from the

definition.

FDA agrees in part. Under section

519(b)(5)(A) of the act, FDA has

exercised its discretion to include

outpatient diagnostic facilities that are

not physician offices in the definition of

‘‘device user facility.’’ Under § 803.3(f),

device user facility means ‘‘a hospital,

ambulatory surgical facility, nursing

home, or an outpatient diagnostic or

treatment facility which is not a

physician’s office.’’ To further clarify

this definition, FDA has included

definitions for the terms ‘‘physician’s

office’’ (§ 803.3(w)), ‘‘hospital’’

(§ 803.3(l)), ‘‘ambulatory surgical

facility,’’ (§ 803.3(b)), ‘‘nursing home’’

(§ 803.3(s)), ‘‘outpatient diagnostic

facility’’ (§ 803.3(t)), and ‘‘outpatient

treatment facility’’ (§ 803.3(u)).

Under section 519(b)(5)(A) of the act,

physicians’ offices are excluded from

the definition of user facilities and are

thereby excluded from adverse event

reporting requirements. FDA believes

that groups performing functions similar

to physicians’ offices such as dental

offices and offices of other health care

practitioners (e.g., chiropractors,

optometrists, nurse practitioners, school

nurse offices, employee health clinics,

free-standing care units) fall within the

definition of ‘‘physician’s office’’ and

therefore should be excluded from

reporting. FDA invites further public

comment on the definition of

‘‘physician’s office’’ and may issue

further guidance as necessary.

FDA has defined ‘‘outpatient

treatment facility’’ as a distinct entity

that operates for the primary purpose of

providing non-surgical therapeutic care.

FDA believes that ambulance or rescue

squad services and independent home

health care agencies fall within this

definition. Given the critical risks posed

by potential malfunctions of devices

used by ambulance services and in

home health care settings, FDA believes

the inclusion of these services within

the definition of ‘‘outpatient treatment

facility’’ is appropriate.

Blood banks that operate in hospitals

or as outpatient treatment or outpatient

diagnostic centers fall within the

definition of user facility. Accordingly,

device-related adverse events that meet

the definition of MDR reportable event,

as defined in § 803.3(q), that occur in

such blood banks must be reported.

FDA invites further public comment on

the definition of user facility and may

issue further guidance as necessary.

9. Several comments stated that the

definition of ‘‘imminent hazard’’

relating to types of adverse events that

FDA proposed should have 3-day

reporting timeframes (proposed

§ 803.3(g)) is unclear. A few comments

suggested that the definition be deleted

because it is too subjective, belongs in

another regulation, or is beyond the

scope of the SMDA. Some comments
63584 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

stated that more than 3 days were

needed for reporting.

FDA agrees. The agency is extending

the time period to make such reports

from 3 days to 5 days. FDA is also

renaming ‘‘imminent hazard reports’’ as

‘‘5-day reports’’ (defined in § 803.3(k)),

and has clarified this requirement in

§ 803.53.

The purpose of the 5-day report is to

alert the agency rapidly to adverse

events that may pose an unreasonable

risk of substantial harm to the public

health. Thus, the definition of ‘‘5-day

report’’ has been revised to mean a

report of an adverse event required by

a manufacturer, submitted on FDA Form

3500A or an FDA approved electronic

equivalent within 5 work days of: (1)

Any employee, who is a person with

management or supervisory

responsibilities over persons with

regulatory, scientific, or technical

responsibilities, or a person whose

duties relate to the collection and

reporting of adverse events, becoming

aware that a reportable MDR event or

events, from any information, including

any trend analysis, necessitates

remedial action to prevent an

unreasonable risk of substantial harm to

the public health; or (2) any employee

becoming aware of an adverse event, if

the manufacturer has received a written

request from FDA for the submission of

a 5-day report for those types of adverse

events. When such a request is made,

the manufacturer shall submit a 5-day

report for all subsequent adverse events

of the same nature that involve

substantially similar devices for the

time period specified in the written

request. The time period stated in the

original written request can be extended

by FDA if it is in the interest of the

public health.

FDA does not intend that a

manufacturer delay or interrupt a

remedial action in order to submit a 5-

day report. The report must be made

within 5 days of the manufacturer

becoming aware that a reportable event

or events necessitate remedial action to

prevent unreasonable risk of substantial

harm to the public health. Information

that would reasonably suggest remedial

action is necessary to prevent such risk

may, for example, be from one MDR

reportable event that makes the

manufacturer aware of a serious design

flaw that necessitates remedial action to

prevent an unreasonable risk of

substantial harm to the public. On the

other hand, information that would

reasonably suggest remedial action is

necessary may result from an internal

trending analysis of several MDR reports

that make the manufacturer aware that

serious injuries or deaths occur at a

much higher frequency than expected.

Further discussion relating to when a

manufacturer is considered aware of a

reportable event is in section IV.A.,

comment 2, of this document.

Manufacturers who submit 5-day

reports are not required to submit

reports of removals and corrections

under section 519(f) of the act. Any

information not available for reporting

under the 5-day reporting timeframe

may be submitted in a supplemental

report.

FDA does not agree with comments

asserting that 5-day reports are beyond

the scope of the SMDA or belong in

another regulation. Requiring 5-day

reports is consistent with FDA’s

authority under section 519(a)(1) of the

act to issue regulations requiring

manufacturers to report information that

reasonably suggests that one of their

marketed devices ‘‘may have caused or

contributed to a death or serious injury,

or has malfunctioned and that such

device * * * would be likely to cause or

contribute to a death or serious injury if

the malfunction were to recur.’’ For the

protection of the public health, FDA

may limit the time allowed to

manufacturers for reporting events of

which the agency should be quickly

aware.

10. Many comments stated that the

requirements relating to user facility

incident files (proposed § 803.35(c)) that

contain documents related to adverse

events that a user facility must maintain

are overly burdensome because the

definition of ‘‘incident files’’ in

proposed § 803.3(h) is overly broad.

Many of these comments suggested that

the definition of incident files be

removed or changed in order to clarify

or limit the scope of requirements

relating to the files. Other comments

suggested that FDA’s access to the files

be limited.

The agency agrees that the definition

of these files (which have been renamed

‘‘MDR event files’’ in § 803.18 of the

final regulation) could be narrowed.

Accordingly, FDA has revised the

definition of MDR event files to include

MDR reports filed with FDA or other

entities, and documents related to the

adverse event, including documents

relating to deliberations and

decisionmaking processes used in the

evaluation or determination of whether

an event is an MDR reportable event.

The final rule also allows the reporter to

incorporate certain information by

reference, such as medical records,

patient files, and engineering reports,

rather than include them in the MDR

event file.

FDA does not agree that agency access

to user facility files should be limited.

Under § 803.18(b), user facilities shall

permit any authorized FDA employee

during all reasonable times to have

access to, and to copy and verify the

records required under part 803. FDA

has authority to inspect files under

section 704(e) of the act (21 U.S.C.

374(e)). Section 704(e) of the act states

that every person required to maintain

records under section 519 of the act, and

every person who is in charge or

custody of such records, shall permit

FDA at all reasonable times to have

access to and to copy and verify such

records. In issuing a regulation stating

its authority under section 704(e) of the

act to have access to user facility

adverse event files, FDA is exercising its

duty under the statute to protect the

public health by ensuring that user

facilities comply with reporting

requirements issued under section 519

of the act.

11. Several comments stated that the

definition of what kind of information

triggers the reporting requirements,

specifically, the definition of

‘‘information that reasonably suggests

that there is a probability that a device

has caused or contributed to a death or

serious injury, or serious illness’’

(proposed § 803.3(i)), is unclear and

requires further definition.

The agency agrees and has clarified

this concept in § 803.20(c). As explained

in section II.B.1 of this document,

section 5 of the 1992 amendments

revised section 519(a)(1) of the act,

subsequent to FDA’s November 1991

tentative final rule, to require the agency

to issue regulations that require

manufacturers and importers to report

to FDA ‘‘whenever the manufacturer or

importer receives or otherwise becomes

aware of information that reasonably

suggests that one of its marketed

devices: (1) May have caused or

contributed to a death or serious injury,

or (2) has malfunctioned and that such

device or a similar device marketed by

the manufacturer or importer would be

likely to cause or contribute to a death

or serious injury if the malfunction were

to recur.’’ Similarly, section 5 of the

1992 amendments revised the reporting

standard for user facilities under section

519(b)(1) (A) and (B) of the act to require

a user facility to submit a report

whenever it receives or otherwise

becomes aware of information ‘‘that

reasonably suggests that a device has or

may have caused or contributed to a

death * * * or serious illness of, or

serious injury to, a patient of the facility

* * *.’’

Under the revised 1992 amendments’

statutory reporting standards, FDA has

no discretion to change the reporting

standards for manufacturers and user
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63585

facilities. Accordingly, FDA has revised

the wording of the reporting standards

in the final regulation for user facilities

and manufacturers to reflect the exact

wording in the 1992 amendments for

these entities. Therefore, the final

regulation requires user facilities and

manufacturers to report certain adverse

events whenever there is ‘‘information

that reasonably suggests that a device

may have caused or contributed to a

death or serious injury.’’

The final rule describes, in § 803.20(c)

‘‘[i]nformation that reasonably suggests

that a device has or may have caused or

contributed to an MDR reportable

event’’ to be any information, such as

professional, scientific or medical facts

and observations or opinions, that

would reasonably suggest that a device

has caused or may have caused or

contributed to an MDR reportable event.

Reports are not required when there is

information that would cause a person

who is qualified to make a medical

judgment (e.g., a physician, risk

manager, or biomedical engineer) to

reach a reasonable conclusion that a

device did not cause or contribute to an

MDR reportable event. Information that

leads to the conclusion that an event is

not reportable must be retained in the

MDR event files for the time periods

specified in § 803.18.

The final rule further defines, in

§ 803.3(d), ‘‘caused or contributed’’ to

mean that a death or serious injury was

or may have been attributable to a

medical device, or that a medical device

was or may have been a factor in the

adverse event including events

occurring as the result of its failure,

malfunction, improper or inadequate

design, labeling, performance,

manufacture, or user error. Devices may

cause or contribute to MDR reportable

events either directly or indirectly.

12. One comment stated that

malfunctions of medical devices used

for a nonmedical purpose should be

exempted. Other comments stated that

the term ‘‘malfunction,’’ as defined in

§ 803.3(m), needed clarification,

especially with regard to implanted

devices. Another comment asked who is

required to report implant malfunctions.

Under this final regulation in subpart

E of part 803 manufacturers must report

certain malfunctions, including implant

malfunctions, that would be likely to

cause or contribute to an MDR

reportable event, regardless of how the

device is used. Although user facilities

are not required by statute or regulation

to report malfunctions, FDA encourages

user facilities to report malfunction

information to manufacturers and

distributors. Malfunction reports

provide important information to FDA

concerning device safety.

Reporters do not need to assess the

likelihood that a malfunction will recur.

The fact that the malfunction occurred

once leads to the presumption that the

malfunction will recur. A malfunction is

reportable if any one of the following is

true: (1) The chance of a death or

serious injury occurring as a result of a

recurrence of the malfunction is not

remote; (2) the consequences of the

malfunction affect the device in a

catastrophic manner that may lead to a

death or serious injury; (3) the

malfunction results in the failure of the

device to perform its essential function

and compromises the device’s

therapeutic, monitoring or diagnostic

effectiveness which could cause or

contribute to a death or serious injury,

or other significant adverse device

experiences required by regulation (the

essential function of a device refers, not

only to the device’s labeled use, but for

any use widely prescribed within the

practice of medicine); (4) the

malfunction involves a long- term

implant or a device that is considered to

be life-supporting or life-sustaining and

thus is essential to maintaining human

life; or (5) the manufacturer takes or

would be required to take an action

under sections 518 or 519(f) of the act

as a result of the malfunction of the

device or other similar devices.

Malfunctions are not reportable if

they are not likely to result in a death,

serious injury or other significant

adverse device experience, that FDA, in

a future rulemaking, may require by

regulation. A malfunction which is or

can be corrected during routine service

or device maintenance must be reported

if the recurrence of the malfunction

would be likely to cause or contribute

to a death or serious injury, or other

significant adverse device experiences

required by a future regulation.

13. Several comments stated that the

definition of a ‘‘manufacturer’’

(§ 803.3(n)), who is subject to adverse

event reporting requirements, is overly

broad with regard to custom devices and

devices modified by users. One

comment suggested that the definition

be modified to include manufacture for

commercial distribution only.

FDA believes that for protection of the

public health, the definition should be

broad enough to provide for reporting

by all persons engaged in the

manufacture, preparation, propagation,

compounding, assembly or processing

of medical devices, who may receive

information about adverse events

related to medical devices, except those

manufacturers exempted under section

519(c) of the act and § 803.19. Under

section 519(c) of the act and § 803.19, a

practitioner licensed by law to prescribe

or administer devices intended for use

in humans and who manufactures or

imports devices solely for use in the

course of that individual’s professional

practice is exempt from reporting.

Manufacturers of devices not being

commercially distributed but which are

being used under an investigational

device exemption are required to report

adverse events under parts 812 and 813

(21 CFR parts 812 and 813) and are not

required to submit reports under part

803. Parts 812 and 813, however,

require reporting of all adverse device

effects.

14. Many comments stated that the

definition of ‘‘MDR reportable event’’

(§ 803.3(q)) is unclear, beyond the scope

of SMDA, or otherwise in need of

revision.

The definition of ‘‘MDR reportable

event’’ has been modified to conform to

revisions made to section 519 of the act

by section 5 of the 1992 amendments.

As defined in § 803.3(q), the revised

definition of ‘‘MDR reportable event’’

mirrors the language of section 519(a)(1)

and (b)(1) of the act, as amended by

section 5 of the 1992 amendments.

FDA has further clarified terms

contained in the definition of an ‘‘MDR

reportable event’’ throughout this

document. These include: ‘‘caused or

contributed,’’ as defined in § 803.3(d)

and discussed in section IV.B., comment

11 of this document; ‘‘information that

reasonably suggests that a device has or

may have caused or contributed to a

death or serious injury’’ as defined in

§ 803.20(c) and discussed in section IV.

B., comment 11 of this document;

‘‘malfunction’’ as defined in § 803.3(m)

and discussed in section IV.B., comment

12 of this document; ‘‘become aware’’ as

defined in § 803.3(c) and discussed in

sections IV.A., comments 2 and 6, and

IV.D., comment 27 of this document;

and ‘‘serious injury,’’ as defined in

§ 803.3(aa) and discussed in section

IV.B., comment 21 of this document.

The terms ‘‘necessitated medical or

surgical intervention’’ and

‘‘permanent,’’ which are now included

in the definition of ‘‘serious injury,’’ are

also clarified in this document.

‘‘Necessitated medical or surgical

intervention’’ is discussed in section

IV.B., comment 16 of this document.

FDA believes that these added

definitions and discussion of these

terms this document provides adequate

clarification of the term ‘‘MDR

reportable event.’’

15. A few comments stated that the

definition of ‘‘manufacturer report

number’’ (§ 803.3(o)), should be changed

to allow flexibility and permit
63586 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

manufacturers to use their own

numbers.

The agency disagrees. A uniform

numbering system is essential for FDA

evaluation of reports, recordkeeping,

filing and analyses. Because the

manufacturer report number is based on

the manufacturer registration number

and all manufacturing sites are required

to have a registration number, there is

no additional burden on the

manufacturer to comply with this

requirement. If the manufacturer

reporting site does not have a

registration number, FDA will assign a

temporary registration until the site is

officially registered.

16. Several comments stated that the

definition of ‘‘necessitated immediate

medical or surgical intervention’’

(proposed § 803.3(o)), included as an

element of the ‘‘serious injury’’

definition in § 803.3(aa), which is

unclear, overly broad, and unduly

burdensome. Some of these comments

suggested that the terms ‘‘timely’’ and

‘‘intervention’’ be further defined or a

standard for ‘‘immediate intervention be

set (e.g., within 6 hours). Other

comments suggested that the event be

reported only if significant intervention

actually occurred.

In light of the 1992 amendments, most

of the comments relating to the

‘‘immediate medical or surgical

intervention’’ definition are no longer

relevant. Section 5(a)(2) of the 1992

amendments revised and broadened the

scope of reportable events that fall

within the definition of ‘‘serious injury’’

by deleting the immediacy requirement

from the definition. Under the 1992

amendments’ revisions, FDA must

require that injuries be reported that

necessitate medical or surgical

intervention to preclude permanent

impairment of a body function or

permanent damage to a body structure,

that have or may have been caused by

a device, regardless of the immediacy of

the surgical or medical intervention.

FDA agrees with comments suggesting

that an event be reported if significant

intervention actually occurred. FDA

believes, however, that any intervention

is per se ‘‘significant’’ if it is necessary

to preclude permanent impairment of a

body function or permanent damage to

a body structure.

17. Many comments stated that the

definition of ‘‘patient of the facility’’

whose serious injuries and deaths user

facilities must report( § 803.3(v)) is too

broad. Several comments objected to

including individuals being diagnosed,

treated, or receiving care ‘‘under the

auspices of’’ the facility under this

definition. Other comments objected to

including employees of the facility who

suffer death or serious injury from a

device used at or by the facility as a

‘‘patient of the facility.’’ They further

asserted that FDA does not have clear

jurisdiction over these types of

employee events and that MDR reports

would duplicate reports required by

other regulations (e.g., Occupational

Safety and Health Administration

(OSHA) regulations). A few comments

suggested that the term ‘‘patient’’ be

further defined.

The agency agrees that including any

individuals treated or diagnosed ‘‘under

the auspices’’ of a facility could be read

very broadly to include certain

individuals that are not intended to be

covered by this regulation. Accordingly,

FDA has revised this definition to

include only individuals that are ‘‘being

diagnosed or treated and/or receiving

medical care at or under the control or

authority of the facility.’’

FDA does not agree, however, that

employees of the facility who are

injured and/or receive medical care

arising from a device-related event at

the facility should be excluded from the

definition of ‘‘patient of the facility,’’

and that information provided to other

agencies for work-related injuries is

duplicative of information required in

an MDR report. FDA believes that

facility employees who suffer injury or

death in a device-related event

reasonably fall within the meaning of

the requirement under section

519(b)(1)(A) of the act to report such

events that involve a ‘‘patient of the

facility.’’ To ensure the safety and

efficacy of devices, FDA needs

information required in the MDR reports

for all device-related adverse events

regardless of the individual’s

employment relationship to the facility.

MDR reports are required to provide

information that is specifically tailored

to help FDA determine the risks posed

by a certain device and whether further

action may be necessary. Reports

required by other agencies relating to

work injuries, such as OSHA, do not

provide the MDR report information

that is necessary for FDA to make these

determinations. Accordingly, there is no

unnecessary duplication involved in

reporting.

18. A few comments stated that

injuries must be reported because they

are ‘‘permanent,’’ (proposed § 803.3(q)),

should exclude ‘‘trivial’’ or ‘‘cosmetic’’

irreversible damage.

FDA agrees in part. To improve

clarity, the agency has included the

definition of ‘‘permanent’’ with the

‘‘serious injury’’ definition (§ 803.3(aa)).

The agency has also modified the

definition of ‘‘serious injury’’ to exclude

trivial irreversible damage. While most

cosmetic damage will be trivial, not all

cosmetic damage would be considered

trivial. Therefore, FDA is not excluding

all cosmetic damage from this

definition.

19. A few comments recommended

that the definition of ‘‘probability,

probable, or probably’’ in the reporting

standard be clarified and suggested

using a ‘‘greater than 50 percent’’

standard.

As discussed earlier in this document,

the 1992 amendments deleted the term

‘‘probability’’ from the reporting

standard and revised the standard for

manufacturers and user facilities.

Therefore, this definition has been

removed from the final rule.

20. A few comments stated that the

definition of a ‘‘remedial action,’’

(§ 803.3(y)), which is required to be

reported under §§ 803.53(a) and

803.52(f)(7), is unclear. One comment

suggested that the definition be deleted;

another suggested that it be removed

from the user reporting form.

The agency does not agree that this

definition should be deleted. The

agency should be aware of remedial

actions taken in response to reportable

events in order to thoroughly evaluate

the event. However, the definition has

been reworded for clarity. Also, the

request for remedial action information

has been removed from the user facility

section of the final reporting form (FDA

Form 3500A) because user facilities do

not ordinarily undertake remedial

actions. The revised definition of

‘‘remedial action’’ appears in § 803.3(y).

21. Several comments stated that the

definition of a reportable ‘‘serious injury

or serious illness’’ (§ 803.3(aa)) is overly

broad and needs to be better defined.

Another comment suggested that these

terms be deleted from the manufacturer

and distributor report forms altogether.

One comment suggested that

‘‘temporary damage’’ be excluded from

the definition.

The agency disagrees with comments

that requirements to report serious

injuries or illnesses should be deleted

from the manufacturer and distributor

reporting form. Section 519(a)(1)(a) of

the act requires manufacturers to report

serious injuries. Nor does FDA agree

that the definitions of these terms are

overly broad. The regulatory definition

in § 803.3(aa) of the terms ‘‘serious

illness’’ and ‘‘serious injury’’ are

derived directly from the statutory

definitions provided in section 519(a)(2)

and (b)(5)(B) of the act, as amended by

the 1992 amendments.

The SMDA added section 519(b)(5)(B)

to require that user facilities report

‘‘serious illnesses’’ as well as ‘‘serious

injuries.’’ The 1992 amendments
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63587

amended section 519(a)(2) to require

that manufacturers report only ‘‘serious

injuries.’’ The statutory definitions of

the terms ‘‘serious injury’’ and ‘‘serious

illness,’’ however, are identical. (See

section 519(a)(2) and (b)(5)(B) of the

act.) The legislative history of the 1992

amendments indicates that ‘‘the term

’injury’ probably covers any illness that

could be caused by a device

* * *.’’(138 Congressional Record H

3884 (1992).)

In accordance with the statutory

definition, FDA has defined ‘‘serious

injury’’ to mean an injury or illness that

is: (1) Life-threatening; (2) results in

permanent impairment of a body

function or permanent damage to body

structure; or (3) necessitates medical or

surgical intervention to preclude

permanent impairment of a body

function or permanent damage to a body

structure.

As stated in response to comments

described in section IV.B., comment 18

of this document, FDA has further

clarified the definition of serious injury

by clarifying the term ‘‘permanent’’

within the definition in § 803.3(aa).

Because section 519(a)(2) and (b)(5)(B),

as amended by the 1992 amendments,

identically defines the terms ‘‘serious

injury’’ and ‘‘serious illness’’ FDA has

revised the definition of the term

‘‘serious injury’’ to include ‘‘serious

illness.’’

FDA does not agree with the comment

stating that temporary damage should

not fall within the definition of ‘‘serious

injury.’’ Section 519(a)(2)(A) and

(b)(5)(B) define serious injury to include

any event that is ‘‘life-threatening.’’

Because life-threatening events may

include temporary damage, FDA

believes that life-threatening events that

may have been caused by a device must

be reported, regardless of whether the

damage was ‘‘temporary.’’

22. One comment stated that the

definition of ‘‘user facility report

number’’ (§ 803.3(dd)) needs to be more

specific, especially regarding leading

zeroes in the number.

The agency agrees and has modified

the definition for clarity. The revised

definition appears in § 803.3(dd).

23. Several comments requested that

the terms: ‘‘become aware,’’ ‘‘expected

life,’’ and ‘‘shelf life’’ be defined.

FDA agrees. These definitions have

been included in the final rule and

appear in § 803.3(c), (i), and (bb)

respectively. For further discussion of

the term ‘‘become aware,’’ see sections

IV.A., comments 2, 6, and IV.D.,

comment 27 of this document.

C. Section 803.9—Public Availability of

Reports

24. Many comments expressed

concern over confidentiality of the

reports.

The agency is aware of confidentiality

concerns and will protect the

confidentiality of information to the

fullest extent allowed under the law.

FDA is generally required, under the

Freedom of Information Act (FOIA) (5

U.S.C. 552), to make publicly available

reports received under this final rule.

Public availability of such reports is

governed by FOIA and part 20 (21 CFR

part 20). Before a report is made

publicly available, FDA, in accordance

with FOIA and part 20 as promulgated

in 1984, will delete from the report

information whose disclosure would

constitute an invasion of personal

privacy (see 5 U.S.C. 552(b)(6); § 20.63)

or information that constitutes trade

secret, confidential commercial or

financial information (see 5 U.S.C.

552(b)(4); § 20.61). Persons who are

subjects of the reports, however, can

receive all information in the report

concerning themselves, except for trade

secret, confidential commercial or

financial information.

FDA has modified § 803.9 in this final

rule to clarify that the identity of a third

party who submits a voluntary adverse

event report, such as a physician or

other health care professional, will be

protected. This revision does not add

any new protection for voluntary thirdparty reporters. It merely clarifies that

the existing protection afforded to

voluntary reporters under § 20.111 is

applicable to MDR reports.

Revised § 803.9 incorporates the

confidentiality provisions relating to

user facility reporting in section

519(b)(2) of the act, as added by the

SMDA. Specifically, § 803.9(c) states

that FDA may not disclose the identity

of a device user facility except in

connection with : (1) An action brought

to enforce section 301(q) of the act (21

U.S.C. 331(q)), which includes the

failure or refusal to furnish material or

information required by section 519 of

the act; (2) a communication to a

manufacturer of a device which is the

subject of a report of a death, serious

injury or other significant adverse

device experience required by a user

facility under § 803.30; (3) a disclosure

relating to a manufacturer or distributor

report which is required under section

519(a) of the act; and (4) a disclosure to

employees of the Department of Health

and Human Services, to the Department

of Justice, or to duly authorized

committees and subcommittees of the

Congress.

As stated above, § 803.9, which is

derived from the statutory language in

section 519(b)(2)(C) of the act, allows

disclosure of the user facility’s identity

when disclosure is required under

provisions requiring manufacturer and

distributor reporting. The legislative

history of section 519(b)(2)(C) of the act

states that this section is not intended

to affect public access to information

contained in MDR reports to FDA, and

that the full requirements of reporting

under section 519(a) of the act (the

manufacturer and distributor reporting

provisions), will apply. If a

manufacturer chooses to forward a user

report to FDA, that will then constitute

a report described in section 519(a) of

the act, not a report described in section

519(b) of the act, for purposes of public

access to the contents of the report. (H.

Rept. 101–808, 101st Cong., 2d sess., pp.

21–22). Accordingly, if information in a

required user facility report is submitted

as part of a distributor or manufacturer

report, the information relating to the

identity of the user facility would be

disclosable because the report would be

submitted under section 519(a) of the

act. FDA notes that, in accordance with

part 20 and section 519(b) of the act, the

agency will not disclose the identity of

the user facility physicians, persons

designated by the user facility to submit

reports, or other user facility employees,

although the identity of the user facility

may be disclosed.

25. Many comments expressed

concern that the regulation will increase

liability and that the availability of

reports will lead to civil litigation.

Although FDA is aware that litigants

in civil suits may attempt to use

information in adverse event reports as

evidence in product liability suits, FDA

does not have any information as to

whether the information from reports

will actually lead to the initiation or

increase of civil litigation. Section 519

of the act requires user facilities and

manufacturers to submit reports of

adverse events. While these reports may

have some effect on a reporter’s liability,

these regulations are required to

implement statutory requirements. They

are also necessary to make FDA aware

of unsafe devices and better enable the

agency to take appropriate action to

safeguard the public health. With

respect to user facilities, section

519(b)(3) of the act provides some

protection against liability in that it

prohibits the admissibility of device

user facility adverse event reports into

evidence for civil actions involving

private parties, except where the party

making the report had knowledge that

information in the report is false.
63588 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

With respect to manufacturers and

distributors, FDA has attempted to

provide protection from liability by

clearly stating in § 803.16 of this final

rule, and including a statement on FDA

Form 3500A, that the submission of a

report does not constitute an admission

that the user facility, manufacturer/

distributor, product, or medical

personnel caused or contributed to the

event. Moreover, in the Federal Register

of April 3, 1995 (60 FR 16962), FDA

issued a final rule that became effective

on July 3, 1995, that protects the

identity of voluntary reporters by

preempting State laws or other

requirements requiring or permitting

disclosure.

26. Comments objected to providing

FDA with proprietary information.

FDA may require the submission of

certain proprietary information because

it is necessary to fully evaluate the

adverse event. Proprietary information

will be kept confidential in accordance

with § 803.9, which prohibits public

disclosure of trade secret or confidential

commercial information, and in

accordance with the FOIA and FDA

regulations in 21 CFR part 20.

D. Reports by Device User Facilities

(Part 803, Subpart C)

27. Several comments stated that 10

days is too short a time period for user

facilities to report adverse events

properly. One comment suggested that

the 10-day ‘‘clock’’ for reporting should

commence when the facility completes

its investigation and determines that an

event is reportable.

FDA cannot agree because the 10-day

time period is the maximum time

allowed by the statute. (See section

519(b)(1)(A) of the act.) However, this

comment raises the issue of when the

reporting ‘‘clock’’ starts. In the preamble

to the November 1991 tentative final

rule, FDA proposed to consider a user

facility to have ‘‘become aware’’ of

reportable events only when it has

sufficient information to make a

determination that a report is required,

and that this commences the 10-day

reporting period. (See the notice of

availability of the MEDWATCH adverse

event reporting form (FDA Form 3500A)

in the Federal Register of June 3, 1993

(58 FR 31596.))

FDA has reevaluated the issue of

when a user facility should be

considered to ‘‘become aware’’ of

information that triggers the reporting

requirements and has determined that

user facilities should be considered to

have ‘‘become aware’’ of information

that triggers reporting requirements

when they first receive a report. The

agency does not believe that

information-gathering required of user

facilities is sufficiently burdensome or

time consuming to justify triggering the

10-day timeframe any time after they

receive a report of an adverse event. A

user facility, unlike a manufacturer, is

not required to provide any information

that is not in its possession. For further

discussion on when user facilities are

considered to have ‘‘become aware’’ of

an event, see section IV.A, comment 2

of this document.

28. Several comments suggested that

the user/operator error reporting

requirement be eliminated.

As stated in section IV.A., comment 3

of this document, the language of the

SMDA as amended by the 1992

amendments requires reporting in all

instances where the facility becomes

aware of information that reasonably

suggests that a device has or may have

caused or contributed to certain devicerelated adverse events. FDA needs to be

aware of events that are related to user

error any time such error may have

caused or contributed to a reportable

event. By receiving information on

device user problems, FDA can

determine whether additional measures

are necessary to resolve such problems,

for example, relabeling or a redesign of

the device.

29. One comment suggested that all

reports be sent only to FDA.

FDA does not agree. This regulation

merely implements section 519(b) of the

act, which requires user facilities to

submit deaths to FDA and the

manufacturer, and serious injuries to the

manufacturer or FDA, if the identity of

the manufacturer is unknown.

30. Some comments suggested that an

anonymous reporting path be provided

for reporting directly to FDA.

FDA disagrees. It is important that

both FDA and the manufacturer know

the identity of the user facility in case

followup information is needed. As

discussed in section IV.C., comment 24

of this document, the act does provide

some protection of the identity of user

facilities.

31. Several comments requested

clarification of the terms ‘‘adverse

events,’’ ‘‘formally affiliated,’’ and ‘‘user

error.’’

Adverse events are those events that

may be related to an FDA-regulated

product and which have a negative or

harmful effect on the user or recipient

of the product’s use. The only adverse

events required to be reported under

this regulation, however, are ‘‘MDR

reportable events’’ as defined in

§ 803.3(q) of the final rule.

The term ‘‘formally affiliated’’ means

individuals who are employed by a user

facility or medical personnel who have

admitting, practicing, or equivalent

privileges at a user facility. Reporting

requirements for user facilities are

triggered when medical personnel who

are employed by or otherwise ‘‘formally

affiliated’’ with the facility, receive

information or become aware of

information that reasonably suggests a

reportable event has occurred.

The term ‘‘user error’’ means any error

made by the person using the device. A

user error may be the sole cause or

merely contribute to a reportable

adverse event.

32. One comment suggested that FDA

provide user facilities with

manufacturer and agency contacts.

Another comment suggested that a

hotline be established for reporting.

It would be very difficult for FDA to

establish and maintain up-to-date

manufacturer ‘‘contact’’ lists for device

user facilities. The agency, however,

will consider publicizing a list of firm

contact names and telephone numbers.

Although there is no requirement for

telephone reporting in this regulation,

emergency situations can be handled in

accordance with § 803.12(c) of this final

rule.

33. One comment asked how foreign

user facilities will be affected by these

provisions.

Only those user facilities located

outside the United States which are

operated by the U.S. Government are

required to report under this regulation.

34. Comments suggested that the

requirements for semiannual reports be

deleted because they are redundant.

Other comments suggested that no

semiannual report be required if no

reports had been submitted during that

period.

Semiannual reports are required by

section 519(b)(1)(C) of the act and

therefore the requirement cannot be

deleted. Under § 803.33(c), the user

facility is not required to submit a

semiannual report if no reportable

events occurred during the reporting

period.

E. Reports by Manufacturers (Part 803,

Subpart E)

35. One comment suggested that

manufacturer reporting of ‘‘planned

remedial actions’’ be deleted. Another

comment stated that remedial action

often occurs after the reporting

deadline, and therefore cannot be

included in the report.

Remedial actions taken after a

reporting deadline can be submitted to

the agency via a supplemental report.

The individual adverse event reports

required under the final rule, with the

exception of circumstances requiring 5-

day reports, do not require information
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63589

concerning ‘‘planned remedial action’’

because supplemental reports and

reports of Removals and Corrections

will provide the agency with the same

information. Remedial actions that are

necessary to prevent an unreasonable

risk to the public health should be

reported as 5-day reports under to

§ 803.53.

36. Several comments requested that

manufacturers be exempt from the

requirement of submitting supplemental

reports because they are vague and

burdensome.

FDA does not agree. The

supplemental report does not impose

any significant additional burden under

§ 803.56 because it requires information

that a manufacturer was required to

submit on its initial report, but did not

do so because such information was

unknown or unavailable at the time of

the report. This information may

include, for example, the results of a

firm’s investigations that may not have

been completed at the time of the initial

report, or any other required

information that the manufacturer

becomes aware of after filing a report.

The information required is not vague

and is clearly specified in §§ 803.52 and

803.56. Both initial and supplemental

reports are to be submitted on FDA

Form 3500A or electronic equivalent.

Under § 803.15, FDA may also require

supplemental information (termed

‘‘request for additional information’’ in

the final rule) in addition to that

required on other reports specified in

this part. FDA believes these reports are

not unduly burdensome given that they

will be required only in instances when

the agency determines that the

protection of the public health requires

such information. In such cases, FDA

will specify the type of information

needed.

37. One comment stated that the

quality of information will decrease if

manufacturers are denied access to

products.

FDA agrees that manufacturers should

evaluate a device problem if they have

access to the device. FDA has no

authority to require that a device be

returned to the manufacturer, but the

agency encourages device users, when

possible, to permit access or return the

device to the manufacturer for

evaluation.

38. One comment suggested that

manufacturer reports should be sent to

user facilities, as well as to FDA.

FDA does not agree. FDA believes that

user facilities do not have the

appropriate resources or personnel to

properly evaluate the public health

significance of manufacturers’ reports.

FDA is the proper entity to evaluate

MDR information to determine whether

further action, including notification to

user facilities or others of device risks,

is appropriate.

39. A few comments suggested that

the 1984 requirements for manufacturer

reporting should be retained to avoid

possible confusion caused by the

creation of a new standard. Other

comments called for the elimination of

the monthly reporting requirement.

As discussed earlier in the preamble,

subsequent to the issuance of the

November 1991 tentative final rule, the

1992 amendments modified the

language for reporting standards that

apply to user facilities, manufacturers,

and importers. The language used in the

November 1991 tentative final rule no

longer reflected the statutory language,

as modified. In this final regulation,

FDA has revised the reporting standard

to reflect the statutory language added

by the 1992 amendments. This statutory

reporting standard is substantially

similar to the manufacturer reporting

standard in the 1984 regulations.

Although the final regulation retains

the reporting standard language from

the 1984 regulation referenced above, it

incorporates many changes from that

regulation that are intended to enhance

the quality of the reports received and

increase the efficiency of FDA’s report

processing. FDA believes the benefits of

changes implemented by the new

regulation far outweigh the limited costs

for manufacturers to familiarize

themselves with the new requirements.

Under the final rule, manufacturers

have 30 days after they become aware of

an MDR event (with the exception of 5-

day reports required by § 803.53) to

report the event to FDA. FDA, however,

has eliminated the portions of monthly

reporting requirements, as proposed,

that would have required manufacturers

to submit, in addition to individual

adverse event report information, an

evaluation of adverse events consisting

of the results of a statistically-based

trend analyses conducted by the

manufacturer, a discussion of the

underlying methodologies used, a

description of any unusual or

unexpected events, and a description of

remedial action taken.

As proposed, the greatest benefit of

the evaluation portions of the monthly

report would have been the overview of

adverse experience trends it would

provide. However, FDA has reevaluated

the benefits of these monthly reports,

and determined that the agency would

incur the costs of data entry regardless

of the industry’s analysis, and that a

computer program for the analysis of the

data may be used at a relatively low cost

to the agency. Furthermore, the agency

anticipates that internal trending

analysis will be conducted as part of a

manufacturer’s CGMP. Any remedial

actions presenting an unreasonable risk

of substantial harm that are undertaken

based upon internal trend analyses are

reportable in a 5-day report. Other

essential information under the

proposed monthly report will also be

made available to the agency under the

CGMP regulations, and would be made

available to FDA under the proposed

reports of removals and corrections

regulation.

The final regulation will also allow

FDA to receive information about

reports sooner than the monthly reports

as previously proposed. The proposed

regulation allowed the manufacturer up

to 2 months from the date of an adverse

event to submit the monthly report. For

example, under the proposed regulation,

information received by the

manufacturer on January 1 would have

been due in a monthly report in March.

Under the final regulation, the

manufacturer will submit all reports of

adverse events within 30 days of the

event. Accordingly, under the final rule,

information about a reportable event the

manufacturer received on January 1,

would have to be reported within 30

days.

FDA believes that the timeframes

under the final regulation allow

sufficient time for completing

individual reports because the

manufacturer would no longer be

required to compile the trend analysis

and other evaluations as previously

proposed for the monthly reports. FDA

also believes that the monthly reporting

of individual adverse events in the final

rule will achieve FDA’s goal of

obtaining better quality initial reports

from manufacturers by allowing more

time to complete the reports than

allowed under the 1984 regulation.

Nonetheless, the public health will

benefit under the final rule because FDA

will receive reports of individual events

sooner than under the proposed rule.

40. One comment objected to the use

of identification (ID) numbers on the

reporting form, claiming they are

unnecessary.

The agency disagrees. Report ID

numbers are essential to FDA’s ability to

efficiently audit, process, analyze and

evaluate MDR data. One of the major

deficiencies of the current system is its

inability to consistently identify similar

devices and other data elements that

facilitate the comparison of adverse

events. The use of device ID numbers

(§§ 803.32(c)(6) and 803.52(c)(6)), user

facility and manufacturer report

numbers (§§ 803.3(dd) and (o),

respectively)), and event codes
63590 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

(discussed in section IV.F., comment 52

of this document) will facilitate

information access and retrieval, and

increase the agency’s ability to evaluate

the information.

41. Comments stated that the

requirement for firms to compare events

associated with the use of their devices,

in order to perform trending studies,

should be removed.

The agency agrees in part and has

deleted MDR trending reporting

requirements, as discussed in section

IV.E, comment 39 of this document.

Under the prior reporting regulation,

FDA has faced difficulties in making an

effective determination of the

significance of many device failures,

because the reports did not include the

total number of similar devices in

current use or similar failures. Such

information, which is required in

baseline reports, provides the agency

with information regarding the rate of

adverse events. An understanding of

device failure rates is essential for the

agency to determine the level of risk

involved, and the appropriate regulatory

or other public health response.

42. One comment suggested that

instead of the manufacturer indicating

to whom the information was reported

in the monthly reporting form, it is more

important to indicate by whom it was

reported.

The agency agrees in part. As noted

above, the monthly report requirement,

as proposed, has been eliminated;

however, information about the initial

reporter is required on the individual

adverse event MEDWATCH form (FDA

Form 3500A or an FDA approved

electronic equivalent).

43. One comment objected to the

requirement to report problems found in

the scientific literature. Another

comment objected to reporting anything

except problems found in the scientific

literature or from research.

Any information which reasonably

suggests that a reportable event occurred

is important to evaluate the risks of a

device, regardless of the source.

Although reports in the scientific

literature or research are usually not

proximate in time to actual events, the

information often represents the results

of cumulative observations and

experience, and provides important

information to FDA about device safety

and effectiveness.

44. One comment stated that the

manufacturer reporting requirements are

inappropriate for device sales made

directly to the patient.

The agency disagrees. The act does

not provide any restrictions or

limitations with respect to how the

device was marketed. FDA would lose

a valuable source of information if

manufacturers of devices sold directly

to patients, such as many apnea

monitors or home use glucose monitors,

were excluded from this requirement.

All information concerning devicerelated deaths, serious injuries or other

reportable events is equally important,

regardless of how the device is

marketed.

45. One comment stated that there is

no relationship between devices

shipped by the manufacturer and those

on the market, as the devices may have

been altered; therefore, the

manufacturer should not be responsible

for reporting events involving such

devices.

The agency disagrees. Devices in

commercial distribution are presumed

to be the same devices shipped by the

manufacturer. If a manufacturer receives

information about an MDR event

involving a device that has been altered,

the information must nevertheless be

forwarded to FDA with an explanation

that the device has been altered.

46. One comment suggested that a

U.S.-designated agent should be

responsible for reporting on behalf of

foreign manufacturers.

FDA’s November 1991 tentative final

rule proposed that U.S.-designated

agents should be required to report for

foreign manufacturers. This requirement

has been adopted in § 803.58.

47. One comment suggested that the

manufacturer should disclose the results

of event evaluations to distributors of

the device.

FDA does not agree. Disclosure of

evaluations would be burdensome and

may result in release of information that

is protected under other laws and

regulations. FDA will inform the public,

including distributors, of steps

necessary to protect the public health if

the agency determines such steps are

necessary.

F. User Facility and Manufacturer

Reporting Forms for Individual Adverse

Events (§§ 803.32 and 803.52)

48. Several comments asserted that

this section is costly, complicated,

overly broad, unacceptably burdensome

and not consistent with the SMDA as it

requires the reporting of information not

required or supported by the SMDA.

The agency disagrees. As stated

earlier in the preamble, FDA has

adopted the use of a single reporting

form for most FDA-regulated products,

in order to facilitate the cost-efficient

submission of information required by

or consistent with the provisions of the

SMDA. The agency agrees that the data

elements could be simplified and has

modified the form after consideration of

comments to the February 1993 notice

submitted by medical device trade

associations and other regulated or

affected entities. FDA anticipates that

the consolidated form will facilitate the

submission, and improve the quality, of

adverse event reports. During the initial

period of its use, FDA will continue to

closely monitor comments and

suggestions received from interested

parties regarding the reporting form, and

will consider additional modifications

to further improve the form as the need

arises.

49. One comment stated that it will be

difficult to find manufacturer reporting

forms. Another comment stated that the

report form, distributed as a draft to

certain interested parties, is not

compatible with the use of a word

processor.

The MEDWATCH forms (FDA Forms

3500 and 3500A) are already in wide

distribution and were published in the

Federal Register on June 3, 1993.

Information about the MEDWATCH

form, and how to obtain it, is provided

§§ 803.10 and 803.11.

Although a word processor would be

able to fill the fields on FDA Form

3500A with great difficulty, the agency

has made provisions for the submission

of reports on alternative (electronic)

media which would obviate the need for

printing the form from a word

processor.

50. Several comments were concerned

with the adversarial and litigation issues

which may be raised by reporting on the

forms. In this regard, a few comments

suggested deleting all items that require

speculation and judgment in reporting,

removing the signature block, or adding

a disclaimer to the form.

As stated in section IV.C., comment

25 of this document, although FDA is

aware that these reports may have some

effect on liability, the required

information is necessary to implement

the agency’s statutory responsibilities.

Under the statute, user facilities and

manufacturers must report adverse

events when a device ‘‘may’’ have

caused or contributed to the event.

Accordingly, FDA does not have the

discretion to require reporting only

when a definitive causal relationship is

established. Furthermore, adoption of

such a standard would preclude FDA

from receiving information that would

help the agency assess the risks

associated with devices.

FDA has removed the signature block

on the form. FDA has provided a

disclaimer statement on the reporting

form, as discussed in section IV.C.,

comment 25 of this document.

51. Some comments suggested that

the evaluation of events or reports be
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63591

left to FDA, the manufacturer or another

third party. Other comments suggested

that the manufacturer should not be

required to verify data or provide data

about which it has no knowledge. Other

comments suggested that user facilities

do not have the appropriate expertise to

analyze events or make determinations

concerning the reportability of events.

FDA agrees that user facilities should

not be required to conduct in-depth

analyses of events and has deleted

certain requirements regarding

information relating to evaluation and

testing. User facilities serve principally

as conduits of information and thus are

required only to fill out information that

is known to them. However, the statute

and regulations still require user

facilities to make an initial

determination as to whether an event

should be reported under the

regulation’s criteria. Accordingly, FDA

has retained elements that relate to this

determination. In § 803.30, FDA

explains user facilities’ obligations to

obtain information about adverse

events.

FDA believes that the manufacturer

who is responsible for placing a device

into interstate commerce is the

appropriate entity to initially investigate

and evaluate whether, and why, the

device may have caused or contributed

to a reportable event or malfunctioned

and that such malfunction is a

reportable event. In order for FDA to

determine whether the risk posed by a

device necessitates action to protect the

public health, the manufacturer is also

required to verify data and provide

missing information after investigating

the event. If after an investigation the

information cannot be determined, a

manufacturer must explain in the MDR

report why the information cannot be

obtained.

The agency agrees that an analysis of

reports for patterns and trends may be

more appropriately conducted by the

manufacturer or FDA. FDA will conduct

statistical analyses of report information

submitted. The agency expects that

manufacturers will conduct trend

analyses as part of their CGMP.

52. Several comments suggested that

numerical event and evaluation codes

should not be used on the adverse event

reporting form. Other comments stated

that the codes lacked accuracy or were

insufficient.

The agency disagrees. It is the

manufacturer’s responsibility to

evaluate reports to determine causation.

It is reasonable that an evaluation will

result in the assignment or

identification of failure modes and that

these can be communicated to FDA in

the form of a structured vocabulary or

‘‘coded’’ data. In developing these

codes, the agency has used the

experience gained from reviewing

nearly 400,000 reports submitted since

1984. The use of these codes is essential

to the rapid evaluation of device risks

and processing of reports by computer.

Regardless of whether the codes are

specific enough to describe a particular

event, the event must be fully described

in the narrative section of the reporting

form.

The list of codes for use with the final

form (FDA Form 3500A or FDA

approved electronic equivalent) has

been expanded for completeness and

modified to improve accuracy. The

agency will continue to improve the

accuracy of its codes as needed.

53. Various comments suggested that

the following elements be removed from

the form: Degree of certainty, labelled

usage, result of analysis, list of other

devices, purchase date, service and

maintenance items, event description,

and medical status of the patient.

FDA has deleted requirements for

user facilities and manufacturers to

report service and maintenance

information and to state the degree of

certainty concerning whether the device

caused or contributed to an adverse

event. FDA believes the burden of

requiring this information would

usually outweigh the benefit of

assessing the cause of an adverse event.

FDA, however, has retained the

requirements for manufacturers to

report use indications specified in the

labeling and device analyses because

this information is valuable in

determining causation of the event. FDA

has deleted the requirements to report

these elements for user facilities because

the agency believes the manufacturer is

the most appropriate source for this

information. All user facilities and

manufacturers will still be required to

provide information regarding

concomitant product use, age of the

device, event description and certain

patient information. FDA believes this

information is important to assess

adverse events and should be available

to user facilities as well as

manufacturers.

G. Manufacturer Annual Certification

Report (§ 803.57)

54. A few comments stated that this

section is redundant, overly broad and

burdensome, exceeds the scope of the

SMDA and should be deleted. Another

comment suggested that certification be

limited to events involving class III

devices.

The agency cannot agree. Section

519(d) of the act states that each

manufacturer required to make reports

under section 519(a) of the act must

submit annual statements certifying the

number of reports filed or that no

reports were filed during the previous

12-month period. The provisions of this

regulation pertaining to the statutory

certification requirement merely explain

what information should be contained

in the submission. Furthermore, FDA

does not agree that certification should

be limited to reports about adverse

events involving class III devices. Any

device, regardless of its classification,

can pose serious risks that need to be

reported to FDA.

55. Some comments suggested that

the certification be limited to the

number of reports actually filed, and

that liability should attach only in

instances of known reporting violations.

The agency disagrees. The purpose of

this provision is to ensure reporter

compliance with MDR requirements by

certifying that all reportable events have

been submitted. Such purpose would be

thwarted and the certification

requirement rendered meaningless if it

were limited to simply certifying the

number of reports submitted instead of

all reportable events known to the

certifying entity. The legislative history

of section 519(d) of the act references a

U.S. General Accounting Office

recommendation that the certification

state that the reporter ‘‘filed a specific

number of reports * * * and that the

firm received or became aware of

information concerning only these

events.’’ (H. Rept. 808, 101st Cong., 2d

sess. 23 (1990)).

Accordingly, consistent with

Congress’ intent, FDA is requiring

certification that all known reportable

events were reported. This requirement

does not impose liability for adverse

events that are unknown to the reporter

because the reporting requirements are

triggered only when the reporting entity

‘‘becomes aware’’ of a reportable event.

56. Several comments stated that the

purpose of certification should be to

verify reports, not to certify with

absoluteness; therefore the standard

should be changed to ‘‘reasonably

certain’’ and a disclaimer should be

added.

The agency disagrees. Section 519(d)

of the act specifically states that firms

shall certify, not verify their reports. As

discussed in the previous paragraph, the

purpose of this provision is to ensure

that the reporter complies with the law

by certifying that it has submitted all the

reports it was required to submit. This

purpose would not be accomplished by

verifying the report.

57. One comment asked for

clarification about who is required to

certify. Another comment suggested that
63592 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

the signature block be for the certifier

and contractor as well.

The agency agrees with the need for

clarification regarding who must certify

and has incorporated language in the

final rule to address this suggestion.

Under the final rule, the president, chief

executive officer, executive officer, U.S.-

designated agent of a foreign

manufacturer or other official most

directly responsible for the firm’s

operations shall certify reports

submitted under section 519 of the act.

58. Two comments requested that

decentralized certification be allowed

for multisite firms. Another comment

suggested that centralized reports be

used in this situation.

Manufacturers have the option of

certifying centrally or on a decentralized

basis. Firms deciding to certify centrally

must identify the sites covered by the

certificate by name and registration

number or FDA-assigned identification

number.

H. Additional Requirements (§ 803.15)

59. A few comments asserted that

these provisions are vague and

inappropriate in the absence of a device

failure complaint.

The agency disagrees. This provision

refers to submission of additional

information after an adverse event

report has been filed. Accordingly, FDA

would not be requesting information in

the absence of a device failure or

complaint.

60. A few comments objected to the

idea of giving FDA unlimited access to

data. One comment wanted to restrict

FDA’s right to copy data and another

wanted an appeal process.

FDA does not agree with comments

proposing to restrict or limit the

agency’s access to additional

information about adverse events.

Under section 704(e) of the act, every

person who is required to maintain

records under section 519 of the act and

every person who is in charge or

custody of such records must permit

FDA at all reasonable times to have

access to and to copy and verify such

records. Failure to provide such

information may be a violation of

section 301 of the act and may subject

a person to civil or criminal penalties.

Section 704(e) of the act does not limit

in any way the types of device records

maintained under section 519 of the act

that FDA may inspect.

FDA does not agree that the agency

should be required to provide an appeal

process with respect to requests for

additional information. As described

above, FDA has statutory authority to

require additional information

concerning adverse events. Moreover,

such information needs to be provided

as quickly as possible to enable FDA to

take appropriate action.

61. Several comments suggested the

regulation be modified to remove the

requirement that each reportable event

be investigated because in some

instances an investigation is

unnecessary.

The agency disagrees. All reportable

events must be investigated by the

manufacturer. The scope of an

investigation may vary according to the

circumstances; however, an

investigation must be able to adequately

assess the cause of the event. Sections

820.162 and 820.198 of FDA’s CGMP

regulations require manufacturers to

review, evaluate and investigate any

complaint involving the failure of a

device to meet its performance

specifications or involving injury, death,

or any hazard to safety. FDA considers

any event that must be reported under

this part to be a death, injury, or hazard

to safety.

I. Exemptions, Variances, and

Alternative Reporting Requirements

(§ 803.19)

62. One comment asked that

alternative reporting requirements

under the current MDR system be

incorporated into this regulation. One

comment stated that the criteria for

alternative reporting should be clarified.

FDA has incorporated the alternative

reporting options from the MDR

regulation issued in 1984 and expanded

the options available in this regulation.

Under the final regulation, FDA may

grant a written exemption, variance, or

alternative to some or all of the

requirements when it determines

compliance with all MDR requirements

is not necessary to protect the public

health. Examples of situations include:

(1) Devices for which FDA is already

aware of a type of malfunction and

appropriate action has been taken to

protect the public health, such as a

recall, removal, or other correction; (2)

adverse events that are known and well

documented, are occurring at a normal

rate, and do not justify the initiation of

remedial action; and (3) device events

occurring on an infrequent basis or

where a longer period for investigation

or followup is appropriate and

necessary.

In these cases, FDA may impose

conditions on its approval of an

exemption, variance, or alternative

reporting mechanism, including the

requirement to report on a less frequent

basis than otherwise required or to

provide summary data rather than

individual reports. The final regulation,

upon its effective date, will supersede

all previously granted exemptions and

variances from the 1984 reporting

requirements. The agency intends to

review all current exemptions and

variances and notify relevant parties

about the status of their exemptions and

variances and the additional steps that

may be necessary to conform to the new

requirements effected by this regulation.

63. A few comments stated the criteria

for exemption are unclear, especially

with respect to investigational device

exemptions, and thus create a loophole.

The criteria for exemptions (§ 803.19)

are based upon interpretations of the act

as to the types of entities Congress

intended should be subject to reporting.

FDA believes these exemptions are

reasonably clear. The exemptions

specifically granted under this final

regulation are the same as those in the

MDR regulation issued in 1984. Devices

subject to investigational device

exemptions are subject to reporting

under the regulations governing that

process (parts 812 and 813). The

exception to this are devices with

investigational device exemptions that

are approved for export. These devices

are considered to be in commercial

distribution and, therefore, subject to

MDR.

J. Where To Submit a Report (§ 803.12)

64. There were only two comments on

this section. One suggested that ‘‘MDR’’

be added to the mailing address. The

other recommended the use of

electronic reporting.

The agency agrees with these

comments. ‘‘MDR’’ has been added to

the mailing address. In addition, the

agency, with prior approval, will accept

required reports submitted

electronically or on reporting media

such as magnetic disc or tape in

accordance with § 803.14(a). The agency

is in the process of developing

standards, guidelines, or procedures for

the format to be used with electronic

reports. Once available, any electronic

reporting system meeting such criteria

will be deemed to have prior FDA

approval.

K. Written MDR Procedures (§ 803.17)

65. A few comments requested

additional guidance on written MDR

procedures.

FDA agrees and has developed

guidance concerning MDR procedures.

Requests for this guidance should be

directed to:

Division of Small Manufacturers

Assistance (HFZ-220), Office of Health

and Industry Programs, Center for

Devices and Radiological Health, 1350

Piccard Dr., Rockville, MD 20850.
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63593

Copies can also be obtained from an

electronic docket maintained by the

Division of Small Manufacturers

Assistance. This system can also be

accessed by dialing: 1–800–252–1366 or

301–594–2741. Persons wishing to

obtain the guidance document via this

system must have a video terminal or a

personal computer with communication

software (VT emulation) and a modem

that can operate at a baud rate of 1200,

2400, 4800, or 9600. Persons wishing to

transfer files from the electronic docket

must use the KERMIT file transfer

protocol.

66. One comment requested that the

requirement for staff education be

deleted.

The agency agrees and, as stated

previously in this preamble, has

removed this requirement from the final

regulation.

67. One comment objected to the

requirement for written procedures.

Another comment objected to FDA

having access to the firm’s procedures.

The agency disagrees. Written

procedures are essential to the

development of a standard, institutional

reporting program. FDA also needs

access to such procedures so it can

conduct an adequate audit of user

facility and manufacturer compliance

with MDR.

68. One comment requested

clarification of the term ‘‘information

that facilitates a submission’’ for which

documentation and recordkeeping

requirements were proposed.

‘‘Information that facilitates the

submission [of a semiannual report]’’

refers to any information that was

evaluated for the purpose of preparing

a semiannual report or certification. The

regulation has been revised in § 803.17

to clarify this point.

69. One comment stated that these

provisions do not address the penalties

for failure to comply.

FDA intends to enforce this regulation

and will take appropriate action against

any firm or facility that does not

comply. Violations may result in

criminal prosecutions and/or civil

remedies such as seizure, injunction,

recall, and civil penalties. FDA’s

enforcement mechanisms and penalties

for noncompliance are detailed in the

preamble to the November 1991

tentative final rule (56 FR 60024 at

60029 through 60030).

L. Files (§ 803.18)

70. Several comments complained

that these requirements are overly

broad, burdensome, and beyond the

scope of the SMDA.

FDA does not agree. Sections 519 and

701 of the act provide FDA the authority

to require user facilities and

manufacturers to maintain records to

ensure that devices are not adulterated

or misbranded. The file requirements

are necessary to enable FDA to: (1)

Further investigate potentially

adulterated or misbranded devices to

determine the cause of adverse events;

(2) verify information received; and (3)

ensure compliance with the regulations.

These filing requirements will also

enable the reporting entity to more

readily identify causes of problems

associated with devices so they can take

appropriate actions.

71. Several comments expressed

concern about public access and a loss

of confidentiality stating that these will

lead to increased lawsuits and,

therefore, decreased reporting. Some

comments suggested that only events

reportable to FDA be kept in FDA

accessible files. Others suggested that

confidential materials and irrelevant

data be excluded from the files.

FDA has addressed issues related to

confidentiality of reports it receives in

section IV.C., comment 24 of this

document. As stated therein, certain

statutory and regulatory protections

exist that prevent release of confidential

information. FDA does not agree that

only events that are ultimately

determined to be reportable should be

kept in MDR files. FDA must be able to

audit files containing events that were

determined not reportable to ensure

such determinations were correct.

72. A few comments objected to FDA

prescribing the method of record

retention, preferring the use of

individual systems.

The agency disagrees. Effective and

uniform regulatory enforcement is better

assured by a standardized method of

record retention. The agency believes

that the method of record retention

prescribed in this regulation does not

impose an undue burden on the entities

required to maintain such records.

73. One comment suggested that

separate files be kept for devices and

patients.

FDA does not object to a reporting

entity maintaining separate files for

devices and patients provided that all

required information is contained in the

MDR files.

74. A few comments stated that a user

facility should be required to keep files

for a maximum of 2 years, rather than

the expected life of the product, because

some devices may have unusually long

life expectancies.

The agency agrees and has modified

this section accordingly. It should be

noted that device manufacturers,

however, are still required to retain their

records for 2 years or a period of time

equivalent to the expected life of the

device, whichever is greater.

M. Who Must Register and Submit a

Device List (Section 807.20)

75. One comment suggested that

foreign manufacturers designate a U.S.

agent to fulfill the registration and

certification requirements. Another

comment suggested that foreign

manufacturers be permitted to register.

Under § 807.40 (21 CFR 807.40),

foreign manufacturers are required to

designate a U.S. agent to serve as an

official correspondent, as well as to

register and list their medical devices

distributed in the United States, submit

premarket notifications and ensure

compliance with the MDR reporting

requirements. In § 807.40(a), FDA has

changed the time allowed for foreign

manufacturers to inform the agency of

their designated U.S. agents, or a change

in such agents, from 30 days to 5 days.

FDA believes this is sufficient time to

comply with this requirement.

76. Under § 807.20 (21 CFR 807.20),

an owner or operator is required to

register its ‘‘name, places of business,

and all establishments.’’ Under this

regulation, FDA has required the

registration of all locations that fit

within the definition of

‘‘establishment,’’ which is defined

under § 807.3(a) (21 CFR 807.3(a)) as a

location where devices are

‘‘manufactured, assembled, or otherwise

processed.’’ Although FDA has

authority under § 807.20 to require the

registration of ‘‘places of business’’ that

are not ‘‘establishments’’ under initial

registration and listing regulation that

were issued in 1977, the agency

previously has declined to exercise this

authority.

Under this regulation, FDA will use

registration numbers in its data bases to

process all manufacturer adverse event

reports. Thus FDA must receive reports

that originate from locations that may

not be ‘‘establishments’’ and, therefore,

have previously not had registration

numbers. Accordingly, FDA is notifying

manufacturers that upon the effective

date of this final regulation, the agency

will exercise its authority under

§ 807.20, and require all locations that

are MDR reporting sites to register

because they are ‘‘places of business’’

under § 807.20, regardless of whether

they fit under the definition of

‘‘establishment.’’

V. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,
63594 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

neither an environmental assessment

nor an environmental impact statement

is required.

VI. Intergovernmental Partnership

The agency has analyzed this

rulemaking in accordance with the

principles and criteria set forth in the

Unfunded Mandate Reform Act (Pub. L.

104–4) and Executive Order 12875.

Executive Order 12875 states that no

agency or executive department shall

promulgate any regulation that is not

required by statute and that creates a

mandate upon a State, local, or tribal

government unless the Federal

government supplies funds necessary to

comply with the mandate, or the agency

provides the Office of Management and

Budget (OMB) a description of the

agency’s consultations with affected

State, local, and tribal governments, the

nature of their concerns, any written

communications submitted to the

agency by such units of government,

and the agency’s position supporting the

need to issue the regulation containing

the mandate. Executive Order 12875

does not apply to this final rule because

the regulatory requirements that are

applicable to government facilities are

required by the provisions of the SMDA,

as amended by the 1992 amendments.

Moreover, many of the comments the

agency received in response to the

November 26, 1991, tentative final rule

were from Federal, State, or local

government facilities or from

organizations representing these

facilities. The agency believes this final

rule is responsive to those comments.

The agency has also examined the

consistency of this final rule with the

Unfunded Mandate Reform Act. The

Unfunded Mandate Reform Act requires

(in section 202) that agencies prepare an

assessment of anticipated costs and

benefits before proposing any rule that

may result in an annual expenditure by

State, local, and tribal governments, in

the aggregate, or by the private sector, of

$100 million (adjusted annually for

inflation). The Unfunded Mandate

Reform Act does not apply to this final

rule because it will not result in an

annual expenditure by State, local, and

tribal governments, in the aggregate, or

by the private sector of $100 million.

VII. Analysis of Impacts

FDA has examined the impact of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the principles set out in the

Executive Order. In addition, the final

rule is not a significant regulatory action

as defined by the Executive Order.

Many comments stated that the

provisions of the rule, as proposed, are

overly burdensome, that the costs

outweigh the benefits, and that the

economic impact was underestimated

and misleading. Several comments

stated that the provisions constitute too

great a burden for FDA, as well as for

user facilities, distributors, and

manufacturers.

The agency does not agree. For the

reasons stated in the preamble,

including section IV.A., comment 1 of

this document, FDA believes this

regulation carefully balances the

interests of public health with industry

requirements. The agency also does not

agree that the economic impact

assessment was misleading. The cost

projections contained in the proposed

rule were based upon the information

available to the agency at the time.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The agency certifies that the

final rule will not have a significant

economic impact on a substantial

number of small entities.

The full economic impact assessment

is on file at the Dockets Management

Branch (address above). This rule is

designed to: (1) Implement provisions of

the SMDA regarding user facility

reporting to FDA of deaths and serious

injuries and illnesses related to medical

devices and (2) amend the MDR

regulations that require manufacturers

to report deaths, serious injuries and

malfunctions related to medical devices

to FDA.

A. Benefits

The legislative history of the SMDA

documents reports that device problems

that occur in hospitals are rarely

reported, despite full scale

implementation of the current medical

device reporting regulation. A 1986

Government Accounting Office report

showed that less than 1 percent of

device problems occurring in hospitals

were reported directly to FDA. As a

result, neither patients nor medical

providers would have access to relevant

safety information. This final rule

requires user facilities to report devicerelated deaths and serious injuries

promptly, and thus it expands the

information base of FDA and the

manufacturer for early detection of

problems associated with medical

devices. In addition to manufacturers,

those required to report to FDA include

device distributors, hospitals, nursing

homes, ambulatory surgical facilities,

and outpatient treatment and diagnostic

facilities. As a result of this rule, FDA,

patients, and medical providers will

have access to relevant safety

information not previously available.

MDR reports alert FDA to lifethreatening and other serious problems

with medical devices that are on the

market, and FDA then can address these

problems through the appropriate

mechanisms. Further, when the final

rule is in place, FDA will begin to

receive denominator, or baseline data,

such as the number of a particular

device manufactured, distributed, and

in use in the previous year. This

information will enable FDA to better

perform trend analyses and determine

the significance of a report or group of

reports.

Unfortunately, there are insufficient

data available to quantify the benefits of

the rule. The primary benefit of this rule

is that it provides an early warning of

device problems which is then

evaluated together with other

information and, if appropriate,

followed by a corrective action such as

the issuance of an FDA Safety Alert,

recall, or other action. The agency

believes the actions taken as a result of

the information provided by MDR

reports will provide benefits such as

injuries prevented, lives saved,

avoidance of hospitalization and

outpatient treatment costs, and other

possible benefits. Any quantification of

benefits would require an estimation of

both the number and seriousness of

adverse events prevented by actions

taken as the result of the evaluation of

MDR reports. Thus the agency does not

believe benefits can be quantified with

any reliable accuracy.

B. Nature of the Economic Impact

This regulation will require certain

device user facilities to develop,

maintain, and implement procedures for

reporting deaths and serious injuries

related to medical devices. Some

current MDR requirements for

manufacturers are being eliminated or

reduced, but manufacturers will now be

required to develop and maintain

written MDR procedures and implement

new reporting requirements, including

the submission of baseline reports and

annual updates and annual certification.

In addition, foreign manufacturers will

be required to designate an agent in the

United States that will be responsible
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63595

for submitting required documents for

complying with the MDR reporting

requirements and for related

documentation.

C. Impact Assessment

Based on the cost analysis, the

economic impact on manufacturers,

U.S. agents for foreign manufacturers,

and users of medical devices will not

exceed the $100 million threshold

established under Executive Order

12866. Annualized one-time costs of

about $9.1 million will be incurred by

industry for establishing and/or

documenting procedures for data

collection and reporting. In addition,

the annual cost of user reporting is

estimated to be $31.7 million, for a total

annualized industry cost of $40.8

million.

An estimated 51,000 additional death

and injury reports are expected as a

result of adverse incidents that must be

reported under this rule. This is in line

with the Congressional Budget Office

estimate of 40,000 reports. These

incidents generate investigation, data

analyses and summaries, and additional

reporting requirements. Based on the

above estimates, this translates to an

average cost per adverse report of $799.

1. User Facility Costs

Table 1 summarizes the total

incremental initial and recurring costs

of the reporting requirements for user

facilities. These estimates are based on

cost data from the Center for Devices

and Radiological Health’s draft report to

Congress, entitled ‘‘The Evaluation of

Medical Device User Facility Reporting

Requirements’’, 1994. Components of

one-time costs include developing

procedures and modifying forms for

reporting and training personnel. The

most significant one-time costs are $3.0

million for developing procedures and

$2.6 million for ‘‘other’’ startup costs.

The total annualized one-time cost to

user facilities is estimated to be $8.9

million.

TABLE 1.—TOTAL COSTS TO USER FACILITIES BY TYPE OF FACILITY

[millions of dollars]

Facility type Number of facilities One-time cost Annualized 1 Annual Total

Hospitals ................................................................................................... 6,738 7.9 1.9 7.0 8.9

Nursing homes ......................................................................................... 25,648 12.7 3.1 5.3 8.4

Ambulatory surgical .................................................................................. 1,300 0.7 0.2 0.7 0.9

Outpatient diagnostic ............................................................................... 7,578 3.3 0.8 0.7 1.5

Outpatient treatment ................................................................................ 4,041 2.5 0.6 1.4 2.0

Emergency medical service ..................................................................... 15,600 9.5 2.3 4.1 6.4

Total ............................................................................................... 60,905 36.6 8.9 19.3 28.2

1Annualized over 5 years at a discount rate of 7 percent. (Numbers may not add due to rounding.)

Annual costs include investigation of

the event, reporting the event, preparing

semiannual reports, and related

computer, and other costs. The total

annual cost to user facilities is $19.3

million. Hospitals and nursing homes

incur about two- thirds of this cost at

$7.0 million and $5.3 million,

respectively. Major components of

annual cost include $5.4 million to

investigate and to prepare the initial

reports. Semiannual reports are required

only if a facility has a reportable event,

and are estimated to cost $59,000. The

most significant costs are for computer

and other costs at $14.8 million. The

total first-year costs to user facilities is

$28.2 million.

2. Manufacturer and U.S. Agent for

Foreign Manufacturer Costs

Manufacturers are currently required

under the current good manufacturing

practices regulation to investigate

complaints and analyze device failures.

Manufacturers will now be required to

document and maintain their MDR

related procedures. The vast majority of

manufacturers already have such

written procedures in place.

Incremental one-time costs for

documenting these procedures will be

$105 thousand. Foreign manufacturers

will incur additional one-time costs of

$662 thousand to select an agent and

notify FDA. Annualized at 7 percent

over 5 years, this translates to $187

thousand per year.

Manufacturers must also comply with

the new reporting requirements. Table 2

presents the expected annual cost of

reporting by type of facility and type of

report. The major components of annual

cost include the followup and reporting

of additional adverse medical device

events and the submission of baseline

reports. MDR followup on user and

distributor reports and completion of

information on Form 3500A is expected

to cost manufacturers $11.1 million

annually for the estimated 51,000

reports from user facilities and

distributors. The cost of 8,000 new

baseline reports and 12,000 updates will

be $598 thousand.

TABLE 2.—ANNUAL COST OF REPORTING

Type of facility Type of report Cost

(dollars)

Number of

reports

Total cost

($000)

All manufacturers .................................................. Followup MDR’s from user/distributor facilities .... 217.60 51,000 11,098

Baseline report ..................................................... 54.40 8,000 435

Baseline update ................................................... 13.60 12,000 163

Five-day report ..................................................... 233.60 100 23

Annual certification ............................................... 26.00 12,145 316

Foreign only .......................................................... Fees for MDR reporting ....................................... .................... .................... 134

Fees for 510(k) filing ............................................ 110.08 510 56

(All manufacturers-Total ) ........................... .............................................................................. .................... .................... 12,225

U.S. agents for foreign manufacturers .................. Register and list ................................................... 16.64 4,812 80
63596 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

TABLE 2.—ANNUAL COST OF REPORTING—Continued

Type of facility Type of report Cost

(dollars)

Number of

reports

Total cost

($000)

Notify and document MDR’s ................................ 7.80 5,750 45

(U.S. agents for foreign manufacturersTotal)............................................................................... .................... .................... 125

Total ............................................................ .............................................................................. .................... .................... 12,350

In addition, domestic manufacturers

and U.S. agents for foreign

manufacturers will be required to certify

annually the number of reportable

events that have occurred. This is a

formality in terms of data collection and

reporting and is expected to cost $316

thousand. Foreign manufacturers will

incur a fee of $190 thousand for

reporting services conducted by their

U.S. agents. Annual costs to U.S. agents

are $125 thousand for registering and

listing their foreign manufacturers

establishments and products and for

complying with reporting requirements.

Previously, foreign manufacturers were

required to submit premarket

notifications or have their initial

distributor in the United States do so.

Now, U.S. agents will be required to

submit premarket notifications for

foreign manufacturers. This represents a

transfer of existing requirements and

therefore, no increase in cost.

3. Total Cost to Industry

Table 3 presents a summary of the

total annual costs to industry. Costs are

$28.2 million for user facilities, $12.4

million for manufacturers, and $125

thousand for U.S. agents for foreign

manufacturers, for a total annual cost to

industry of $40.8 million.

TABLE 3.—TOTAL ANNUALIZED COST

TO INDUSTRY

[in millions of dollars]

Industry Onetime 1 Annual Total

User Facilities ........... 8.93 19.31 28.24

Manufacturers ........... 0.19 12.22 12.41

TABLE 3.—TOTAL ANNUALIZED COST

TO INDUSTRY—Continued

[in millions of dollars]

Industry Onetime 1 Annual Total

U.S. agents

for foreign

manufactuers ........... .............. 0.13 0.13

Total . 9.12 31.66 40.77

1Annualized over 5 years at a discount rate

of 7 percent. (Numbers may not add due to

rounding.)

4. Small Business Impacts

There is little likelihood that there

will be a significant impact on small

facilities. The one-time start-up costs

range from $437 to $1,629 for user

facilities, depending on facility type.

Annualized at 7 percent for 5 years,

these costs range from $107 to $397 for

user facilities. In addition, estimates of

the annual number of additional

medical device events attributable to

this regulation are about 51,000.

Because there are nearly 61,000 user

facilities, this averages out to about .8

serious events per facility attributable to

the user reporting rule at an annual cost

of $400 per event.

Similarly, small businesses in the

medical device manufacturing industry

will not be significantly affected,

although the industry has a substantial

number of small facilities, with about 65

percent of the establishments having

fewer than 50 employees. No more than

22 percent of the anticipated $12

million annual impact of these

regulations on manufacturers would be

attributable to small establishments, or

about $2.7 million per year. Because

there are about 7,300 small medical

device establishments (including foreign

manufacturers), the average impact on

one small establishment should be less

than $338 annually. Assuming that all

of the approximately 4,800 U.S. agents

are small, on average, the $125 thousand

impact on any one establishment would

be $26 annually.

VIII. Paperwork Reduction Act of 1995

This final rule contains information

collections which are subject to review

by OMB under the Paperwork

Reduction Act of 1995 (Pub. L. 104–13).

The title, description, and respondent

description of the information

collections are shown below and an

estimate of the annual recordkeeping

and periodic reporting burden. Included

in the estimate is the time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information.

Title: Reporting and recordkeeping

requirements for user facilities and

manufacturers of medical devices under

the Safe Medical Devices Act of 1990

(SMDA) and the Medical Device

Amendments of 1992 (1992

Amendments)(General requirements).

Description: This regulation

implements provisions of the SMDA

and the 1992 amendments regarding

user facility reporting of deaths and

serious injuries related to medical

devices. This regulation also amends

regulations regarding device

manufacturer reporting of deaths,

serious injuries, and certain

malfunctions related to medical devices.

The purpose of these changes is to

improve the protection of the public

health while also reducing the

regulatory burden on reporting entities.

Description of Respondents:

Businesses or other for profit

organizations, nonprofit organizations,

Federal, State, and local governments.

TABLE 4.—ESTIMATED ANNUAL BURDEN FOR REPORTING

CFR section Number of

respondents

Number of

responses

per respondent

Total annual

responses

Hours per

response Total hours

803.19 ...................................................................................................... 100 1.0 100 3.0 300
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63597

TABLE 4.—ESTIMATED ANNUAL BURDEN FOR REPORTING—Continued

CFR section Number of

respondents

Number of

responses

per respondent

Total annual

responses

Hours per

response Total hours

803.30(a) .................................................................................................. 700 1.0 700 3.0 2,100

803.30(b) .................................................................................................. 20,000 1.5 30,000 3.0 90,000

803.33 ...................................................................................................... 2,000 1.0 2,000 1.0 2,000

803.50 ...................................................................................................... 1,250 40.0 50,000 0.5 25,000

803.53 ...................................................................................................... 100 1.0 100 0.5 50

803.55 ...................................................................................................... 1,000 20.0 20,000 1 1.1 22,000

803.56 ...................................................................................................... 500 20.0 10,000 1.0 10,000

803.57 ...................................................................................................... 12,000 1.0 12,000 1.0 12,000

803.58 ...................................................................................................... 5,000 1.0 5,000 1.0 5,000

Total ............................................................................................... .................... .................... .................... .................... 168,450

1Although an initial submission will take an estimated 2 hours to complete, the annual update will take only .5 hours. The average hours per

response is therefore 1.1, as reflected here.

TABLE 5.—ESTIMATED ANNUAL BURDEN FOR RECORDKEEPING

CFR section

Number of

recordkeepers

Hours per

recordkeeperTotal hours

803.18(c) .................................................................................................................................................. 36,639 0.25 9,160

803.18(e) .................................................................................................................................................. 625 16.00 10,000

Total .............................................................................................................................................. .................... .................... 19,160

Although the November 26, 1991,

tentative final rule provided a 60-day

comment period (extended to 90 days in

the January 24, 1992, Federal Register,

57 FR 2861), and this final rule is based

on the comments received, FDA Form

3419 (semiannual report), FDA Form

3417 (baseline report), and FDA Form

3381 (annual certification) have not

been previously available to OMB or the

public for review. Therefore, as required

by section 3507(d) of the Paperwork

Reduction Act of 1995, FDA has

submitted a copy of this final rule to

OMB for its review of these information

collection requirements.

In addition, the agency solicits public

comment on the information collection

requirements in order to: (1) Evaluate

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

agency, including whether the

information will have practical utility;

(2) evaluate the accuracy of the agency’s

estimate of the burden of the proposed

collection of information, including the

validity of the methodology and

assumptions used; (3) enhance the

quality, utility, and clarity of the

information to be collected; and (4)

minimize the burden of the collection of

information on those who are to

respond, including through the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology, e.g., permitting

electronic submission of responses.

Individuals and organizations may

submit comments on the information

collection requirements by January 10,

1996, and should direct them to FDA’s

Dockets Management Branch (address

above) and to the Office of Information

and Regulatory Affairs, OMB, New

Executive Office Bldg., rm. 10235, 725

17th St. NW., Washington, DC 20503,

Attention: Desk Officer for FDA.

Persons are not required to respond to

a collection of information unless it

displays a currently valid OMB control

number. This final rule contains

information collection requirements

which have been approved under OMB

no. 0910–0059 and which expires on

March 31, 1996. FDA will publish a

notice in the Federal Register prior to

the effective date of this final rule of

OMB’s decision to approve, modify or

disapprove the information collection

requirements.

List of Subjects

21 CFR Part 803

Imports, Medical devices, Reporting

and recordkeeping requirements.

21 CFR Part 807

Confidential business information,

Medical devices, Reporting and

recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

authority delegated to the Commissioner

of Food and Drugs, chapter I of title 21

of the Code of Federal Regulations is

amended as follows:

1. Part 803 is revised to read as

follows:

PART 803—MEDICAL DEVICE

REPORTING

Subpart A—General Provisions

Sec.

803.1 Scope.

803.3 Definitions.

803.9 Public availability of reports.

803.10 General description of reports

required from user facilities and

manufacturers.

803.11 Obtaining the forms.

803.12 Where to submit reports.

803.13 English reporting requirement.

803.14 Electronic reporting.

803.15 Requests for additional information.

803.16 Disclaimers.

803.17 Written MDR procedures.

803.18 Files.

803.19 Exemptions, variances, and

alternative reporting requirements.

Subpart B—Generally Applicable

Requirements for Individual Adverse Event

Reports

803.20 How to report.

803.21 Reporting codes.

803.22 When not to file.
63598 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

Subpart C—User Facility Reporting

Requirements

803.30 Individual adverse event reports;

user facilities.

803.32 Individual adverse event report data

elements.

803.33 Semiannual reports.

Subpart D—[Reserved]

Subpart E—Manufacturer Reporting

Requirements

803.50 Individual adverse event reports;

manufacturers.

803.52 Individual adverse event report data

elements.

803.53 Five-day reports.

803.55 Baseline reports.

803.56 Supplemental reports.

803.57 Annual certification.

803.58 Foreign manufacturers.

Authority: Secs. 502, 510, 519, 520, 701,

704 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 352, 360, 360i, 360j, 371, 374).

Subpart A—General Provisions

§ 803.1 Scope.

(a) This part establishes requirements

for medical device reporting. Under this

part, device user facilities and

manufacturers must report deaths and

serious injuries to which a device has or

may have caused or contributed, and

must establish and maintain adverse

event files. Manufacturers are also

required to report certain device

malfunctions and submit an annual

report to FDA certifying that the correct

number of medical device reports were

filed during the previous 12-month

period or, alternatively, that no reports

were required during that same time

period. These reports will assist FDA in

protecting the public health by helping

to ensure that devices are not

adulterated or misbranded and are safe

and effective for their intended use.

(b) This part supplements and does

not supersede other provisions of this

subchapter, including the provisions of

part 820 of this chapter.

(c) References in this part to

regulatory sections of the Code of

Federal Regulations are to Chapter I of

title 21, unless otherwise noted.

§ 803.3 Definitions.

(a) Act means the Federal Food, Drug,

and Cosmetic Act.

(b) Ambulatory surgical facility (ASF)

means a distinct entity that operates for

the primary purpose of furnishing same

day outpatient surgical services to

patients. An ASF may be either an

independent entity (i.e., not a part of a

provider of services or any other

facility) or operated by another medical

entity (e.g., under the common

ownership, licensure or control of an

entity). An ASF is subject to this

regulation regardless of whether it is

licensed by a Federal, State, municipal,

or local government or regardless of

whether it is accredited by a recognized

accreditation organization. If an adverse

event meets the criteria for reporting,

the ASF must report that event

regardless of the nature or location of

the medical service provided by the

ASF.

(c) Become aware means that an

employee of the entity required to report

has acquired information reasonably

suggesting a reportable adverse event

has occurred. Device user facilities are

considered to have ‘‘become aware’’

when medical personnel, as defined in

paragraph (r) of this section, who are

employed by or otherwise formally

affiliated with the facility, acquire such

information about a reportable event.

Manufacturers are considered to have

‘‘become aware’’ of an event when:

(1) Any employee becomes aware of a

reportable event that is required to be

reported within 30 days, or that is

required to be reported within 5 days

pursuant to a written request from FDA

under 803.53(b); and

(2) Any employee, who is a person

with management or supervisory

responsibilities over persons with

regulatory, scientific, or technical

responsibilities, or a person whose

duties relate to the collection and

reporting of adverse events, becomes

aware that a reportable MDR event or

events, from any information, including

any trend analysis, necessitate remedial

action to prevent an unreasonable risk

of substantial harm to the public health.

(d) Caused or contributed means that

a death or serious injury was or may

have been attributed to a medical

device, or that a medical device was or

may have been a factor in a death or

serious injury, including events

occurring as a result of:

(1) Failure;

(2) Malfunction;

(3) Improper or inadequate design;

(4) Manufacture;

(5) Labeling; or

(6) User error.

(e) (1) Device family means a group of

one or more devices manufactured by or

for the same manufacturer and having

the same:

(i) Basic design and performance

characteristics related to device safety

and effectiveness,

(ii) Intended use and function, and

(iii) Device classification and product

code.

(2) Devices that differ only in minor

ways not related to safety or

effectiveness can be considered to be in

the same device family. Factors such as

brand name and common name of the

device and whether the devices were

introduced into commercial distribution

under the same 510(k) or premarket

approval application (PMA), may be

considered in grouping products into

device families.

(f) Device user facility means a

hospital, ambulatory surgical facility,

nursing home, outpatient diagnostic

facility, or outpatient treatment facility

as defined in paragraphs (l), (b), (s), (t),

and (u), respectively, of this section,

which is not a ‘‘physician’s office,’’ as

defined in paragraph (w) of this section.

School nurse offices and employee

health units are not device user

facilities.

(g) [Reserved]

(h) [Reserved]

(i) Expected life of a device (required

on the manufacturer’s baseline report)

means the time that a device is expected

to remain functional after it is placed

into use. Certain implanted devices

have specified ‘‘end of life’’ (EOL) dates.

Other devices are not labeled as to their

respective EOL, but are expected to

remain operational through

maintenance, repair, upgrades, etc., for

an estimated period of time.

(j) FDA means the Food and Drug

Administration.

(k) Five-day report means a medical

device report that must be submitted by

a manufacturer to FDA pursuant to

§ 803.53, on FDA Form 3500A or

electronic equivalent as approved under

§ 803.14, within 5 work days.

(l) Hospital means a distinct entity

that operates for the primary purpose of

providing diagnostic, therapeutic

(medical, occupational, speech,

physical, etc.), surgical and other

patient services for specific and general

medical conditions. Hospitals include

general, chronic disease, rehabilitative,

psychiatric, and other special-purpose

facilities. A hospital may be either

independent (e.g., not a part of a

provider of services or any other

facility) or may be operated by another

medical entity (e.g., under the common

ownership, licensure or control of

another entity). A hospital is covered by

this regulation regardless of whether it

is licensed by a Federal, State,

municipal or local government or

whether it is accredited by a recognized

accreditation organization. If an adverse

event meets the criteria for reporting,

the hospital must report that event

regardless of the nature or location of

the medical service provided by the

hospital.

(m) Malfunction means the failure of

a device to meet its performance

specifications or otherwise perform as

intended. Performance specifications

include all claims made in the labeling

for the device. The intended
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63599

performance of a device refers to the

intended use for which the device is

labeled or marketed, as defined in

§ 801.4 of this chapter.

(n) Manufacturer means any person

who manufactures, prepares,

propagates, compounds, assembles, or

processes a device by chemical,

physical, biological, or other procedure.

The term includes any person who:

(1) Repackages or otherwise changes

the container, wrapper or labeling of a

device in furtherance of the distribution

of the device from the original place of

manufacture;

(2) Initiates specifications for devices

that are manufactured by a second party

for subsequent distribution by the

person initiating the specifications;

(3) Manufactures components or

accessories which are devices that are

ready to be used and are intended to be

commercially distributed and intended

to be used as is, or are processed by a

licensed practitioner or other qualified

person to meet the needs of a particular

patient; or

(4) Is the U.S. agent of a foreign

manufacturer.

(o) Manufacturer report number

means the number that uniquely

identifies each individual adverse event

report submitted by a manufacturer.

This number consists of three parts as

follows:

(1) The FDA registration number for

the manufacturing site of the reported

device. (If the manufacturing site does

not have a registration number, FDA

will assign a temporary number until

the site is officially registered. The

manufacturer will be informed of the

temporary number.);

(2) The four-digit calendar year in

which the report is submitted; and

(3) The five-digit sequence number of

the reports submitted during the year,

starting with 00001. (For example, the

complete number will appear 1234567–

1995–00001.)

(p) MDR means medical device report.

(q) MDR reportable event (or

reportable event) means:

(1) An event about which user

facilities become aware of information

that reasonably suggests that a device

has or may have caused or contributed

to a death or serious injury; or

(2) An event about which

manufacturers have received or become

aware of information that reasonably

suggests that one of their marketed

devices:

(i) May have caused or contributed to

a death or serious injury; or

(ii) Has malfunctioned and that the

device or a similar device marketed by

the manufacturer would be likely to

cause or contribute to a death or serious

injury if the malfunction were to recur.

(r) Medical personnel, as used in this

part, means an individual who:

(1) Is licensed, registered, or certified

by a State, territory, or other governing

body, to administer health care;

(2) Has received a diploma or a degree

in a professional or scientific discipline;

(3) Is an employee responsible for

receiving medical complaints or adverse

event reports; or

(4) Is a supervisor of such persons.

(s)(1) Nursing home means an

independent entity (i.e., not a part of a

provider of services or any other

facility) or one operated by another

medical entity (e.g., under the common

ownership, licensure, or control of an

entity) that operates for the primary

purpose of providing:

(i) Skilled nursing care and related

services for persons who require

medical or nursing care;

(ii) Hospice care to the terminally ill;

or

(iii) Services for the rehabilitation of

the injured, disabled, or sick.

(2) A nursing home is subject to this

regulation regardless of whether it is

licensed by a Federal, State, municipal,

or local government or whether it is

accredited by a recognized accreditation

organization. If an adverse event meets

the criteria for reporting, the nursing

home must report that event regardless

of the nature, or location of the medical

service provided by the nursing home.

(t)(1) Outpatient diagnostic facility

means a distinct entity that:

(i) Operates for the primary purpose

of conducting medical diagnostic tests

on patients;

(ii) Does not assume ongoing

responsibility for patient care; and

(iii) Provides its services for use by

other medical personnel. (Examples

include diagnostic radiography,

mammography, ultrasonography,

electrocardiography, magnetic

resonance imaging, computerized axial

tomography and in-vitro testing).

(2) An outpatient diagnostic facility

may be either independent (i.e., not a

part of a provider of services or any

other facility) or operated by another

medical entity (e.g., under the common

ownership, licensure, or control of an

entity). An outpatient diagnostic facility

is covered by this regulation regardless

of whether it is licensed by a Federal,

State, municipal, or local government or

whether it is accredited by a recognized

accreditation organization. If an adverse

event meets the criteria for reporting,

the outpatient diagnostic facility must

report that event regardless of the nature

or location of the medical service

provided by the outpatient diagnostic

facility.

(u) (1) Outpatient treatment facility

means a distinct entity that operates for

the primary purpose of providing

nonsurgical therapeutic (medical,

occupational, or physical) care on an

outpatient basis or home health care

setting. Outpatient treatment facilities

include ambulance providers, rescue

services, and home health care groups.

Examples of services provided by

outpatient treatment facilities include:

Cardiac defibrillation, chemotherapy,

radiotherapy, pain control, dialysis,

speech or physical therapy, and

treatment for substance abuse.

(2) An outpatient treatment facility

may be either independent (i.e., not a

part of a provider of services or any

other facility) or operated by another

medical entity (e.g., under the common

ownership, licensure, or control of an

entity). An outpatient treatment facility

is covered by this regulation regardless

of whether it is licensed by a Federal,

State, municipal, or local government or

whether it is accredited by a recognized

accreditation organization. If an adverse

event meets the criteria for reporting,

the outpatient treatment facility must

report that event regardless of the nature

or location of the medical service

provided by the outpatient treatment

facility.

(v) Patient of the facility means any

individual who is being diagnosed or

treated and/or receiving medical care at

or under the control or authority of the

facility. For the purposes of this part,

the definition encompasses employees

of the facility or individuals affiliated

with the facility, who in the course of

their duties suffer a device-related death

or serious injury that has or may have

been caused or contributed to by a

device used at the facility.

(w) Physician’s office means a facility

that operates as the office of a physician

or other health care professional (e.g.,

dentist, chiropractor, optometrist, nurse

practitioner, school nurse offices, school

clinics, employee health clinics, or freestanding care units) for the primary

purpose of examination, evaluation, and

treatment or referral of patients. A

physician’s office may be independent,

a group practice, or part of a Health

Maintenance Organization.

(x) [Reserved]

(y) Remedial action means, for the

purposes of this subpart, any action

other than routine maintenance or

servicing, of a device where such action

is necessary to prevent recurrence of a

reportable event.

(z) [Reserved]

(aa)(1) Serious injury means an injury

or illness that:
63600 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

(i) Is life-threatening;

(ii) Results in permanent impairment

of a body function or permanent damage

to body structure; or

(iii) Necessitates medical or surgical

intervention to preclude permanent

impairment of a body function or

permanent damage to a body structure.

(2) Permanent means, for purposes of

this subpart, irreversible impairment or

damage to a body structure or function,

excluding trivial impairment or damage.

(bb) Shelf life, as required on the

manufacturer’s baseline report, means

the maximum time a device will remain

functional from the date of manufacture

until it is used in patient care. Some

devices have an expiration date on their

labeling indicating the maximum time

they can be stored before losing their

ability to perform their intended

function.

(cc) [Reserved]

(dd)(1) User facility report number

means the number that uniquely

identifies each report submitted by a

user facility to manufacturers and FDA.

This number consists of three parts as

follows:

(i) The user facility’s 10-digit Health

Care Financing Administration (HCFA)

number (if the HCFA number has fewer

than 10 digits, fill the remaining spaces

with zeros);

(ii) The four-digit calendar year in

which the report is submitted; and

(iii) The four-digit sequence number

of the reports submitted for the year,

starting with 0001. (For example, a

complete number will appear as

follows: 1234560000–1995–0001.)

(2) If a facility has more than one

HCFA number, it must select one that

will be used for all of its MDR reports.

If a facility has no HCFA number, it

should use all zeros in the appropriate

space in its initial report (e.g.,

0000000000–1995–0001) and FDA will

assign a number for future use. The

number assigned will be used in FDA’s

record of that report and in any

correspondence with the user facility.

All zeros should be used subsequent to

the first report if the user does not

receive FDA’s assigned number before

the next report is submitted. If a facility

has multiple sites, the primary site can

report centrally and use one reporting

number for all sites if the primary site

provides the name, address and HCFA

number for each respective site.

(ee) Work day means Monday through

Friday, excluding Federal holidays.

§ 803.9 Public availability of reports.

(a) Any report, including any FDA

record of a telephone report, submitted

under this part is available for public

disclosure in accordance with part 20 of

this chapter.

(b) Before public disclosure of a

report, FDA will delete from the report:

(1) Any information that constitutes

trade secret or confidential commercial

or financial information under § 20.61 of

this chapter;

(2) Any personal, medical, and similar

information (including the serial

number of implanted devices), which

would constitute an invasion of

personal privacy under § 20.63 of this

chapter. FDA will disclose to a patient

who requests a report, all the

information in the report concerning

that patient, as provided in § 20.61 of

this chapter; and

(3) Any names and other identifying

information of a third party voluntarily

submitting an adverse event report.

(c) FDA may not disclose the identity

of a device user facility which makes a

report under this part except in

connection with:

(1) An action brought to enforce

section 301(q) of the act, including the

failure or refusal to furnish material or

information required by section 519 of

the act;

(2) A communication to a

manufacturer of a device which is the

subject of a report required by a user

facility under § 803.30;

(3) A disclosure relating to a

manufacturer or distributor adverse

event report that is required under

section 519(a) of the act; or

(4) A disclosure to employees of the

Department of Health and Human

Services, to the Department of Justice, or

to the duly authorized committees and

subcommittees of the Congress.

§ 803.10 General description of reports

required from user facilities and

manufacturers.

(a) Device user facilities. User

facilities must submit the following

reports, which are described more fully

in subpart C of this part.

(1) User facilities must submit MDR

reports of individual adverse events

within 10 days after the user facility

becomes aware of an MDR reportable

event as described in §§ 803.30 and

803.32.

(i) User facilities must submit reports

of device-related deaths to FDA and to

the manufacturer, if known.

(ii) User facilities must submit reports

of device-related serious injuries to

manufacturers, or to FDA, if the

manufacturer is unknown.

(2) User facilities must submit

semiannual reports as described in

§ 803.33.

(b) [Reserved]

(c) Device manufacturers.

Manufacturers must submit the

following reports as described more

fully in subpart E of this part:

(1) MDR reports of individual adverse

events within 30 days after the

manufacturer becomes aware of a

reportable death, serious injury, or

malfunction as described in §§ 803.50

and 803.52.

(2) MDR reports of individual adverse

events within 5 days of:

(i) Becoming aware that a reportable

MDR event requires remedial action to

prevent an unreasonable risk of

substantial harm to the public health or,

(ii) Becoming aware of an MDR

reportable event for which FDA has

made a written request, as described in

§ 803.53.

(3) Annual baseline reports as

described in § 803.55.

(4) Supplemental reports if they

obtain information that was not

provided in an initial report as

described in § 803.56.

(5) Annual certification to FDA of the

number of MDR reports filed during the

preceding year as described in § 803.57.

§ 803.11 Obtaining the forms.

User facilities and manufacturers

must submit all reports of individual

adverse events on FDA Form 3500A

(MEDWATCH form) or in an electronic

equivalent as approved under § 803.14.

This form and all other forms referenced

in this section can also be obtained from

the Consolidated Forms and

Publications Office, Washington

Commerce Center, 3222 Hubbard Rd.,

Landover, MD 20785, or from the

Division of Small Manufacturers

Assistance, Office of Health and

Industry Programs, Center for Devices

and Radiological Health, 1350 Piccard

Dr. (HFZ–220), Rockville, MD 20850,

telephone facsimile (FAX) 301–443–

8818. FDA Form 3500A may also be

obtained from the Food and Drug

Administration, MEDWATCH (HF–2),

5600 Fishers Lane, rm. 9–57, Rockville,

MD 20850, 301–443–0117.

§ 803.12 Where to submit reports.

(a) Any written report or additional

information required under this part

shall be submitted to: Food and Drug

Administration, Center for Devices and

Radiological Health, Medical Device

Reporting, PO Box 3002, Rockville, MD

20847–3002.

(b) Each report and its envelope shall

be specifically identified, e.g., ‘‘User

Facility Report,’’ ‘‘SemiAnnual Report,’’

‘‘Manufacturer Report,’’ ‘‘5-Day Report,’’

‘‘Baseline Report,’’ etc.

(c) If an entity is confronted with a

public health emergency, this can be

brought to FDA’s attention by contacting

the FDA Emergency Operations Branch
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63601

(HFC–162), Office of Regional

Operations, at 301–443–1240, and

should be followed by the submission of

a FAX report to 301–443–3757.

(d) A voluntary telephone report may

be submitted to, or information

regarding voluntary reporting may be

obtained from, the MEDWATCH hotline

at 800–FDA–1088.

§ 803.13 English reporting requirement.

(a) All reports required in this part

which are submitted in writing or

electronic equivalent shall be submitted

to FDA in English.

(b) All reports required in this part

which are submitted on an electronic

medium shall be submitted to FDA in a

manner consistent with § 803.14.

§ 803.14 Electronic reporting.

(a) Any report required by this part

may be submitted electronically with

prior written consent from FDA. Such

consent is revocable. Electronic report

submissions include alternative

reporting media (magnetic tape, disc,

etc.) and computer-to-computer

communication.

(b) Any electronic report meeting

electronic reporting standards,

guidelines, or other procedures

developed by the agency for MDR

reporting will be deemed to have prior

approval for use.

§ 803.15 Requests for additional

information.

(a) FDA may determine that

protection of the public health requires

additional or clarifying information for

medical device reports submitted to

FDA under this part. In these instances,

and in cases when the additional

information is beyond the scope of FDA

reporting forms or is not readily

accessible, the agency will notify the

reporting entity in writing of the

additional information that is required.

(b) Any request under this section

shall state the reason or purpose for

which the information is being

requested, specify the date that the

information is to be submitted and

clearly relate the request to a reported

event. All verbal requests will be

confirmed in writing by the agency.

§ 803.16 Disclaimers.

A report or other information

submitted by a reporting entity under

this part, and any release by FDA of that

report or information, does not

necessarily reflect a conclusion by the

party submitting the report or by FDA

that the report or information

constitutes an admission that the

device, or the reporting entity or its

employees, caused or contributed to the

reportable event. The reporting entity

need not admit and may deny that the

report or information submitted under

this part constitutes an admission that

the device, the party submitting the

report, or employees thereof, caused or

contributed to a reportable event.

§ 803.17 Written MDR procedures.

User facilities and manufacturers

shall develop, maintain, and implement

written MDR procedures for the

following:

(a) Internal systems that provide for:

(1) Timely and effective

identification, communication, and

evaluation of events that may be subject

to medical device reporting

requirements;

(2) A standardized review process/

procedure for determining when an

event meets the criteria for reporting

under this part; and

(3) Timely transmission of complete

medical device reports to FDA and/or

manufacturers;

(b) Documentation and recordkeeping

requirements for:

(1) Information that was evaluated to

determine if an event was reportable;

(2) All medical device reports and

information submitted to FDA and

manufacturers;

(3) Any information that was

evaluated for the purpose of preparing

the submission of semiannual reports or

certification; and

(4) Systems that ensure access to

information that facilitates timely

followup and inspection by FDA.

§ 803.18 Files.

(a) User facilities and manufacturers

shall establish and maintain MDR event

files. All MDR event files shall be

prominently identified as such and filed

to facilitate timely access.

(b) (1) For purposes of this part,

‘‘MDR event files’’ are written or

electronic files maintained by user

facilities and manufacturers. MDR event

files may incorporate references to other

information, e.g., medical records,

patient files, engineering reports, etc., in

lieu of copying and maintaining

duplicates in this file. MDR event files

must contain:

(i) Information in the possession of

the reporting entity or references to

information related to the adverse event,

including all documentation of the

entity’s deliberations and

decisionmaking processes used to

determine if a device-related death,

serious injury, or malfunction was or

was not reportable under this part.

(ii) Copies of all MDR forms, as

required by this part, and other

information related to the event that was

submitted to FDA and other entities

(e.g., a distributor or manufacturer).

(2) User facilities and manufacturers

shall permit any authorized FDA

employee during all reasonable times to

access, to copy, and to verify the records

required by this part.

(c) User facilities shall retain an MDR

event file relating to an adverse event

for a period of 2 years from the date of

the event. Manufacturers shall retain an

MDR event file relating to an adverse

event for a period of 2 years from the

date of the event or a period of time

equivalent to the expected life of the

device, whichever is greater. MDR event

files must be maintained for the time

periods described in this paragraph

even if the device is no longer

distributed.

(d) [Reserved]

(e) The manufacturer may maintain

MDR event files as part of its complaint

file, under § 820.198 of this chapter,

provided that such records are

prominently identified as MDR

reportable events. A report submitted

under this subpart A shall not be

considered to comply with this part

unless the event has been evaluated in

accordance with the requirements of

§§ 820.162 and 820.198 of this chapter.

MDR files shall contain an explanation

of why any information required by this

part was not submitted or could not be

obtained. The results of the evaluation

of each event are to be documented and

maintained in the manufacturer’s MDR

event file.

§ 803.19 Exemptions, variances, and

alternative reporting requirements.

(a) The following persons are exempt

from the reporting requirements under

this part.

(1) An individual who is a licensed

practitioner who prescribes or

administers devices intended for use in

humans and who manufactures or

imports devices solely for use in

diagnosing and treating persons with

whom the practitioner has a ‘‘physicianpatient’’ relationship.

(2) An individual who manufactures

devices intended for use in humans

solely for such person’s use in research

or teaching and not for sale, including

any person who is subject to alternative

reporting requirements under the

investigational device exemption

regulations, parts 812 and 813 of this

chapter, which require reporting of all

adverse device effects.

(3) Dental laboratories, or optical

laboratories.

(b) Manufacturers or user facilities

may request exemptions or variances

from any or all of the reporting

requirements in this part. The request

shall be in writing and include

information necessary to identify the
63602 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

firm and device, a complete statement of

the request for exemption, variance, or

alternative reporting, and an

explanation why the request is justified.

(c) FDA may grant in writing, to a

manufacturer or user facility, an

exemption, variance or alternative from,

or to, any or all of the reporting

requirements in this part and may

change the frequency of reporting to

quarterly, semiannually, annually, or

other appropriate time period. These

modifications may be initiated by a

request as specified in this section, or at

the discretion of FDA. When granting

such modifications, FDA may impose

other reporting requirements to ensure

the protection of public health.

(d) FDA may revoke or modify in

writing an exemption, variance, or

alternative reporting requirements if

FDA determines that protection of the

public health justifies the modification

or a return to the requirements as stated

in this part.

(e) Firms granted a reporting

modification by FDA shall provide any

reports or information required by that

approval. The conditions of the

approval will replace and supersede the

reporting requirement specified in this

part until such time that FDA revokes or

modifies the alternative reporting

requirements in accordance with

paragraph (d) of this section.

Subpart B—Generally Applicable

Requirements for Individual Adverse

Event Reports

§ 803.20 How to report.

(a) Description of form. There are two

versions of the MEDWATCH form for

individual reports of adverse events.

FDA Form 3500 is available for use by

health professionals and consumers for

the submission of voluntary reports

regarding FDA-regulated products. FDA

Form 3500A is the mandatory reporting

form to be used for submitting reports

by user facilities and manufacturers of

FDA-regulated products. The form has

sections that must be completed by all

reporters and other sections that must

be completed only by the user facility or

manufacturer.

(1) The front of FDA Form 3500A is

to be filled out by all reporters. The

front of the form requests information

regarding the patient, the event, the

device and ‘‘initial reporter’’ (i.e., the

first person or entity that submitted the

information to the user facility,

manufacturer, or distributor).

(2) The back part of the form contains

sections to be completed by user

facilities and manufacturers. User

facilities must complete section F;

device manufacturers must complete

sections G and H. Manufacturers are not

required to recopy information

submitted to them on a Form 3500A

unless the information is being copied

onto an electronic medium. If the

manufacturer corrects or supplies

information missing from the other

reporter’s 3500A form, it should attach

a copy of that form to the

manufacturer’s report form. If the

information from the other reporter’s

3500A form is complete and correct, the

manufacturer can fill in the remaining

information on the same form.

(b) Reporting standards. (1) User

facilities are required to submit MDR

reports to:

(i) The device manufacturer and to

FDA within 10 days of becoming aware

of information that reasonably suggests

that a device has or may have caused or

contributed to a death; or

(ii) The manufacturer within 10 days

of becoming aware of information that

reasonably suggests that a device has or

may have caused or contributed to a

serious injury. Such reports shall be

submitted to FDA if the device

manufacturer is not known.

(2) [Reserved]

(3) Manufacturers are required to

submit MDR reports to FDA:

(i) Within 30 days of becoming aware

of information that reasonably suggests

that a device may have caused or

contributed to a death or serious injury;

or

(ii) Within 30 days of becoming aware

of information that reasonably suggests

a device has malfunctioned and that

device or a similar device marketed by

the manufacturer would be likely to

cause a death or serious injury if the

malfunction were to recur; or

(iii) Within 5 days if required by

§ 803.53.

(c) Information that reasonably

suggests a reportable event occurred (1)

Information that reasonably suggests

that a device has or may have caused or

contributed to an MDR reportable event

(i.e., death, serious injury, and, for

manufacturers, a malfunction that

would be likely to cause or contribute

to a death or serious injury if the

malfunction were to recur) includes any

information, such as professional,

scientific or medical facts and

observations or opinions, that would

reasonably suggest that a device has

caused or may have caused or

contributed to a reportable event.

(2) Entities required to report under

this part do not have to report adverse

events for which there is information

that would cause a person who is

qualified to make a medical judgment

(e.g., a physician, nurse, risk manager,

or biomedical engineer) to reach a

reasonable conclusion that a device did

not cause or contribute to a death or

serious injury, or that a malfunction

would not be likely to cause or

contribute to a death or serious injury if

it were to recur. Information which

leads the qualified person to determine

that a device-related event is or is not

reportable must be contained in the

MDR event files, as described in

§ 803.18.

§ 803.21 Reporting codes.

(a) FDA has developed a MEDWATCH

Mandatory Reporting Form Coding

Manual for use with medical device

reports. This manual contains codes for

hundreds of adverse events for use with

FDA Form 3500A. The coding manual is

available from the Division of Small

Manufacturer Assistance, Center for

Devices and Radiological Health, 1350

Piccard Dr., Rockville, MD 20850, FAX

301–443–8818.

(b) FDA may use additional coding of

information on the reporting forms or

modify the existing codes on an ad hoc

or generic basis. In such cases, FDA will

ensure that the new coding information

is available to all reporters.

§ 803.22 When not to file.

(a) Only one medical device report

from the user facility or manufacturer is

required under this part if the reporting

entity becomes aware of information

from multiple sources regarding the

same patient and same event.

(b) A medical device report that

would otherwise be required under this

section is not required if:

(1) The user facility or manufacturer

determines that the information

received is erroneous in that a devicerelated adverse event did not occur.

Documentation of such reports shall be

retained in MDR files for time periods

specified in § 803.18.

(2) The manufacturer determines that

the device was manufactured by another

manufacturer. Any reportable event

information that is erroneously sent to

a manufacturer shall be forwarded to

FDA, with a cover letter explaining that

the device in question was not

manufactured by that firm.

Subpart C—User Facility Reporting

Requirements

§ 803.30 Individual adverse event reports;

user facilities.

(a) Reporting standard. A user facility

shall submit the following reports to the

manufacturer or to FDA, or both, as

specified below:

(1) Reports of death. Whenever a user

facility receives or otherwise becomes

aware of information, from any source,

that reasonably suggests that a device
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63603

has or may have caused or contributed

to the death of a patient of the facility,

the facility shall as soon as practicable,

but not later than 10 work days after

becoming aware of the information,

report the information required by

§ 803.32 to FDA, on FDA Form 3500A,

or an electronic equivalent as approved

under § 803.14, and if the identity of the

manufacturer is known, to the device

manufacturer.

(2) Reports of serious injury.

Whenever a user facility receives or

otherwise becomes aware of

information, from any source, that

reasonably suggests that a device has or

may have caused or contributed to a

serious injury to a patient of the facility,

the facility shall, as soon as practicable

but not later than 10 work days after

becoming aware of the information,

report the information required by

§ 803.32, on FDA Form 3500A or

electronic equivalent, as approved

under § 803.14, to the manufacturer of

the device. If the identity of the

manufacturer is not known, the report

shall be submitted to FDA.

(b) Information that is reasonably

known to user facilities. User facilities

must provide all information required in

this subpart C that is reasonably known

to them. Such information includes

information found in documents in the

possession of the user facility and any

information that becomes available as a

result of reasonable followup within the

facility. A user facility is not required to

evaluate or investigate the event by

obtaining or evaluating information that

is not reasonably known to it.

§ 803.32 Individual adverse event report

data elements.

User facility reports shall contain the

following information, reasonably

known to them as described in

803.30(b), which corresponds to the

format of FDA Form 3500A:

(a) Patient information (Block A) shall

contain the following:

(1) Patient name or other identifier;

(2) Patient age at the time of event, or

date of birth;

(3) Patient gender; and

(4) Patient weight.

(b) Adverse event or product problem

(Block B) shall contain the following:

(1) Identification of adverse event or

product problem;

(2) Outcomes attributed to the adverse

event, e.g., death; or serious injury, that

is:

(i) Life threatening injury or illness;

(ii) Disability resulting in permanent

impairment of a body function or

permanent damage to a body structure;

or

(iii) Injury or illness that requires

intervention to prevent permanent

impairment of a body structure or

function;

(3) Date of event;

(4) Date of report by the initial

reporter;

(5) Description of event or problem,

including a discussion of how the

device was involved, nature of the

problem, patient followup or required

treatment, and any environmental

conditions that may have influenced the

event;

(6) Description of relevant tests

including dates and laboratory data; and

(7) Description of other relevant

history including pre- existing medical

conditions.

(c) Device information (Block D) shall

contain the following:

(1) Brand name;

(2) Type of device;

(3) Manufacturer name and address;

(4) Operator of the device (health

professional, patient, lay user, other);

(5) Expiration date;

(6) Model number, catalog number,

serial number, lot number, or other

identifying number;

(7) Date of device implantation

(month, day, year);

(8) Date of device explantation

(month, day, year);

(9) Whether device was available for

evaluation and whether device was

returned to the manufacturer; if so, the

date it was returned to the

manufacturer; and

(10) Concomitant medical products

and therapy dates. (Do not list products

that were used to treat the event.)

(d) Initial reporter information (Block

E) shall contain the following:

(1) Name, address, and telephone

number of the reporter who initially

provided information to the user

facility, manufacturer, or distributor;

(2) Whether the initial reporter is a

health professional;

(3) Occupation; and

(4) Whether initial reporter also sent

a copy of the report to FDA, if known.

(e) User facility information (Block F)

shall contain the following:

(1) Whether reporter is a user facility;

(2) User facility number;

(3) User facility address;

(4) Contact person;

(5) Contact person’s telephone

number;

(6) Date the user facility became

aware of the event (month, day, year);

(7) Type of report (initial or followup

(if followup, include report number of

initial report));

(8) Date of the user facility report

(month, day, year);

(9) Approximate age of device;

(10) Event problem codes—patient

code and device code (refer to FDA

‘‘Coding Manual For Form 3500A’’);

(11) Whether a report was sent to FDA

and the date it was sent (month, day,

year);

(12) Location, where event occurred;

(13) Whether report was sent to the

manufacturer and the date it was sent

(month, day, year); and

(14) Manufacturer name and address;

if available.

§ 803.33 Semiannual reports.

(a) Each user facility shall submit to

FDA a semiannual report on FDA Form

3419, or electronic equivalent as

approved by FDA under § 803.14.

Semiannual reports shall be submitted

by January 1 (for reports made July

through December) and by July 1 (for

reports made January through June) of

each year. The semiannual report and

envelope shall be clearly identified and

submitted to FDA with information that

includes:

(1) User facility’s HCFA provider

number used for medical device reports,

or number assigned by FDA for

reporting purposes in accordance with

§ 803.3(dd);

(2) Reporting year and period, e.g.,

January through June or July through

December;

(3) Facility’s name and complete

address;

(4) Total number of reports attached

or summarized;

(5) Date of the semiannual report and

the lowest and highest user facility

report number of medical device reports

submitted during the report period, e.g.,

1234567890–1995–0001 through 1000;

(6) Name, position title, and complete

address of the individual designated as

the facility contact person responsible

for reporting to FDA and whether that

person is a new contact for that facility;

and

(7) Information for each reportable

event that occurred during the

semiannual reporting period including:

(i) User facility report number;

(ii) Name and address of the device

manufacturer;

(iii) Device brand name and common

name;

(iv) Product model, catalog, serial and

lot number;

(v) A brief description of the event

reported to the manufacturer and/or

FDA; and

(vi) Where the report was submitted,

i.e., to FDA, manufacturer, distributor,

etc.

(b) In lieu of submitting the

information in paragraph (a)(7) of this

section, a user facility may submit a

copy of FDA Form 3500A, or an

electronic equivalent as approved under

section 803.14, for each medical device

report submitted to FDA and/or
63604 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

manufacturers by that facility during the

reporting period.

(c) If no reports are submitted to

either FDA or manufacturers during

these time periods, no semiannual

report is required.

Subpart D—[Reserved]

Subpart E—Manufacturer Reporting

Requirements

§ 803.50 Individual adverse event reports;

manufacturers.

(a) Reporting standards. Device

manufacturers are required to report

within 30 days whenever the

manufacturer receives or otherwise

becomes aware of information, from any

source, that reasonably suggests that a

device marketed by the manufacturer:

(1) May have caused or contributed to

a death or serious injury; or

(2) Has malfunctioned and such

device or similar device marketed by the

manufacturer would be likely to cause

or contribute to a death or serious

injury, if the malfunction were to recur.

(b) Information that is reasonably

known to manufacturers.—(1)

Manufacturers must provide all

information required in this subpart E

that is reasonably known to them. FDA

considers the following information to

be reasonably known to the

manufacturer:

(i) Any information that can be

obtained by contacting a user facility,

distributor and/or other initial reporter;

(ii) Any information in a

manufacturer’s possession; or

(iii) Any information that can be

obtained by analysis, testing or other

evaluation of the device.

(2) Manufacturers are responsible for

obtaining and providing FDA with

information that is incomplete or

missing from reports submitted by user

facilities, distributors, and other initial

reporters. Manufacturers are also

responsible for conducting an

investigation of each event, and

evaluating the cause of the event. If a

manufacturer cannot provide complete

information on an MDR report, it must

provide a statement explaining why

such information was incomplete and

the steps taken to obtain the

information. Any required information

not available at the time of the report,

which is obtained after the initial filing,

must be provided by the manufacturer

in a supplemental report under § 803.56.

§ 803.52 Individual adverse event report

data elements.

Individual medical device

manufacturer reports shall contain the

following information, known or

reasonably known to them as described

in § 803.50(b), which corresponds to the

format of FDA Form 3500A:

(a) Patient information (Block A) shall

contain the following:

(1) Patient name or other identifier;

(2) Patient age at the time of event, or

date of birth;

(3) Patient gender; and

(4) Patient weight.

(b) Adverse event or product problem

(Block B) shall contain the following:

(1) Adverse event or product problem;

(2) Outcomes attributed to the adverse

event, e.g., death; or serious injury, that

is:

(i) Life threatening injury or illness;

(ii) Disability resulting in permanent

impairment of a body function or

permanent damage to a body structure;

or

(iii) Injury or illness that requires

intervention to prevent permanent

impairment of a body structure or

function;

(3) Date of event;

(4) Date of report by the initial

reporter;

(5) Description of the event or

problem to include a discussion of how

the device was involved, nature of the

problem, patient followup or required

treatment, and any environmental

conditions that may have influenced the

event;

(6) Description of relevant tests,

including dates and laboratory data; and

(7) Other relevant patient history

including pre-existing medical

conditions.

(c) Device information (Block D) shall

contain the following:

(1) Brand name;

(2) Type of device;

(3) Manufacturer name and address;

(4) Operator of the device (health

professional, patient, lay user, other);

(5) Expiration date;

(6) Model number, catalog number,

serial number, lot number or other

identifying number;

(7) Date of device implantation

(month, day, year);

(8) Date of device explantation

(month, day, year);

(9) Whether the device was available

for evaluation, and whether the device

was returned to the manufacturer, and

if so, the date it was returned to the

manufacturer; and

(10) Concomitant medical products

and therapy dates. (Do not list products

that were used to treat the event.)

(d) Initial reporter information (Block

E) shall contain the following:

(1) Name, address, and phone number

of the reporter who initially provided

information to the user facility,

manufacturer, or distributor;

(2) Whether the initial reporter is a

health professional;

(3) Occupation; and

(4) Whether the initial reporter also

sent a copy of the report to FDA, if

known.

(e) All manufacturers (Block G) shall

contain the following:

(1) Contact office name and address

and device manufacturing site;

(2) Telephone number;

(3) Report sources;

(4) Date received by manufacturer

(month, day, year);

(5) Type of report being submitted

(e.g., 5-day, initial, supplemental); and

(6) Manufacturer report number.

(f) Device manufacturers (Block H)

shall contain the following:

(1) Type of reportable event (death,

serious injury, malfunction, etc.);

(2) Type of followup report, if

applicable (e.g., correction, response to

FDA request, etc.);

(3) If the device was returned to the

manufacturer and evaluated by the

manufacturer, a summary of the

evaluation. If no evaluation was

performed, provide an explanation why

no evaluation was performed;

(4) Device manufacture date (month,

day, year);

(5) Was device labeled for single use;

(6) Evaluation codes (including event

codes, method of evaluation, result, and

conclusion codes) (refer to FDA ‘‘Coding

Manual for Form 3500A’’);

(7) Whether remedial action was

taken and type;

(8) Whether use of device was initial,

reuse, or unknown;

(9) Whether remedial action was

reported as a removal or correction

under section 519(f) of the act (list the

correction/removal report number); and

(10) Additional manufacturer

narrative; and/or

(11) Corrected data, including:

(i) Any information missing on the

user facility report or distributor report,

including missing event codes, or

information corrected on such forms

after manufacturer verification;

(ii) For each event code provided by

the user facility under § 803.32(d)(10) or

a distributor, a statement of whether the

type of the event represented by the

code is addressed in the device labeling;

and

(iii) If any required information was

not provided, an explanation of why

such information was not provided and

the steps taken to obtain such

information.

§ 803.53 Five-day reports.

A manufacturer shall submit a 5-day

report to FDA, on Form 3500A or

electronic equivalent as approved by

FDA under § 803.14 within 5 workdays

of:
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63605

(a) Becoming aware that a reportable

MDR event or events, from any

information, including any trend

analysis, necessitates remedial action to

prevent an unreasonable risk of

substantial harm to the public health; or

(b) Becoming aware of an MDR

reportable event for which FDA has

made a written request for the

submission of a 5-day report. When

such a request is made, the

manufacturer shall submit, without

further requests, a 5-day report for all

subsequent events of the same nature

that involve substantially similar

devices for the time period specified in

the written request. The time period

stated in the original written request can

be extended by FDA if it is in the

interest of the public health.

§ 803.55 Baseline reports.

(a) A manufacturer shall submit a

baseline report on FDA Form 3417, or

electronic equivalent as approved by

FDA under § 803.14 for a device when

the device model is first reported under

§ 803.50.

(b) Each baseline report shall be

updated annually, on the anniversary

month of the initial submission, after

the initial baseline report is submitted.

Changes to baseline information shall be

reported in the manner described in

§ 803.56 (i.e., include only the new,

changed, or corrected information in the

appropriate portion(s) of the report

form). Baseline reports shall contain the

following:

(1) Name, complete address, and

registration number of the

manufacturer’s reporting site. If the

reporting site is not registered, FDA will

assign a temporary registration number

until the reporting site officially

registers. The manufacturer will be

informed of the temporary registration

number;

(2) FDA registration number of each

site where the device is manufactured;

(3) Name, complete address, and

telephone number of the individual who

has been designated by the

manufacturer as its MDR contact and

date of the report. For foreign

manufacturers, a confirmation that the

individual submitting the report is the

agent of the manufacturer designated

under § 803.58(a) is required;

(4) Product identification, including

device family, brand name, generic

name, model number, catalog number,

product code and any other product

identification number or designation;

(5) Identification of any device

previously reported in a baseline report

that is substantially similar (e.g., same

device with a different model number,

or same device except for cosmetic

differences in color or shape) to the

device being reported, including the

identification of the previously reported

device by model number, catalog

number or other product identification,

and the date of the baseline report for

the previously reported device;

(6) Basis for marketing, including

510(k) premarket notification number or

PMA number, if applicable, and

whether the device is currently the

subject of an approved post-market

study under section 522 of the act;

(7) Date the device was initially

marketed and, if applicable, the date on

which the manufacturer ceased

marketing the device;

(8) Shelf life, if applicable, and

expected life of the device;

(9) The number of devices

manufactured and distributed in the last

12 months and, an estimate of the

number of devices in current use; and

(10) Brief description of any methods

used to estimate the number of devices

distributed and the method used to

estimate the number of devices in

current use. If this information was

provided in a previous baseline report,

in lieu of resubmitting the information,

it may be referenced by providing the

date and product identification for the

previous baseline report.

§ 803.56 Supplemental reports.

When a manufacturer obtains

information required under this part

that was not provided because it was

not known or was not available when

the initial report was submitted, the

manufacturer shall submit to FDA the

supplemental information within 1

month following receipt of such

information. In supplemental reports,

the manufacturer shall:

(a) Indicate on the form and the

envelope, that the reporting form being

submitted is a supplemental report. If

the report being supplemented is an

FDA Form 3500A report, the

manufacturer must select, in Item H–2,

the appropriate code for the type of

supplemental information being

submitted;

(b) Provide the appropriate

identification numbers of the report that

will be updated with the supplemental

information, e.g., original manufacturer

report number and user facility report

number, if applicable;

(c) For reports that cross reference

previous reports, include only the new,

changed, or corrected information in the

appropriate portion(s) of the respective

form(s).

§ 803.57 Annual certification.

All manufacturers, including U.S.

agents of foreign manufacturers required

to report under this section, shall

submit a certification report to FDA, on

FDA Form 3381, or electronic

equivalent as approved under part 814

of this chapter. The date for submission

of certification coincides with the date

for the firm’s annual registration, as

designated in § 807.21 of this chapter.

The certification period will be the 12-

month period ending 1 month before the

certification date. The reports shall

contain the following information:

(a) Name, address, telephone number,

and FDA registration number or FDAassigned identification number of the

firm and whether the firm is a

manufacturer;

(b) A statement certifying that:

(1) The firm listed in paragraph (a) of

this section has filed reports for all

reportable events required under this

section during the previous 12-month

period. The firm shall also provide a

numerical summary of MDR reports that

it submitted to FDA during the

preceding year; or

(2) The firm listed in paragraph (a) of

this section did not receive reportable

events for any devices manufactured by

the firm during the previous 12-month

period.

(c) Certification shall be made by the

president, chief executive officer, U.S.-

designated agent of a foreign

manufacturer, or other official most

directly responsible for the firm’s

operations; and

(d) Name of the manufacturer and

registration numbers submitted under

paragraph (a) of this section shall be the

same as those used in submitting the

reports required by §§ 803.52, 803.53

and 803.55. Multisite manufacturers

who choose to certify centrally must

identify the reporting sites, by

registration number or FDA-assigned

identification number and name

covered by the certification, and provide

the information required by paragraph

(b) of this section for each reporting site.

§ 803.58 Foreign manufacturers.

(a) Every foreign manufacturer whose

devices are distributed in the United

States shall designate a U.S. agent to be

responsible for reporting in accordance

with § 807.40 of this chapter. The U.S.

designated agent accepts responsibility

for the duties that such designation

entails. Upon the effective date of this

regulation, foreign manufacturers shall

inform FDA, by letter, of the name and

address of the U.S. agent designated

under this section and § 807.40 of this

chapter, and shall update this

information as necessary. Such updated

information shall be submitted to FDA,

within 5 days of a change in the

designated agent information.
63606 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

(b) U.S.-designated agents of foreign

manufacturers are required to:

(1) Report to FDA in accordance with

§§ 803.50, 803.52, 803.53, 803.55, and

803.56;

(2) Conduct, or obtain from the

foreign manufacturer the necessary

information regarding, the investigation

and evaluation of the event to comport

with the requirements of § 803.50;

(3) Certify in accordance with

§ 803.57;

(4) Forward MDR complaints to the

foreign manufacturer and maintain

documentation of this requirement;

(5) Maintain complaint files in

accordance with § 803.18; and

(6) Register, list, and submit

premarket notifications in accordance

with part 807 of this chapter.

PART 807—ESTABLISHMENT

REGISTRATION AND DEVICE LISTING

FOR MANUFACTURERS AND

DISTRIBUTORS OF DEVICES

2. The authority citation for 21 CFR

part 807 continues to read as follows:

Authority: Secs. 301, 501, 502, 510, 513,

515, 519, 520, 701, 704 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 331, 351,

352, 360, 360c, 360e, 360i, 360j, 371, 374).

3. Section 807.3 is amended by

adding new paragraph (r) to read as

follows:

§ 807.3 Definitions.

* * * * *

(r) U.S.-designated agent means the

person, residing in the United States,

designated and authorized by the owner

or operator of a foreign manufacturer

who exports devices into the United

States and is responsible for:

(1) Submitting MDR reports,

(2) Submitting annual certifications,

(3) Acting as the official

correspondent,

(4) Submitting registration

information,

(5) Submitting device listing

information, and

(6) Submitting premarket notifications

on behalf of the foreign manufacturer.

4. Section 807.20 is amended by

adding new paragraph (a)(6) to read as

follows:

§ 807.20 Who must register and submit a

device list.

(a) * * *

(6) Acts as the U.S.-designated agent

as defined in § 807.3(r).

* * * * *

5. Section 807.22 is amended by

revising paragraph (a) to read as follows:

§ 807.22 How and where to register

establishments and list devices.

(a) The first registration of a device

establishment shall be on Form FDA–

2891 (Initial Registration of Device

Establishment). Forms are available

upon request from the Office of

Compliance, Center for Devices and

Radiological Health (HFZ–307), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, or from Food

and Drug Administration district offices.

Subsequent annual registration shall be

accomplished on Form FDD–2891a

(Annual Registration of Device

Establishment), which will be furnished

by FDA to establishments whose

registration for that year was validated

under § 807.35(a). The forms will be

mailed to the owner or operators of all

establishments via the official

correspondent in accordance with the

schedule as described in § 807.21(a).

The completed form shall be mailed to

the address designated in this paragraph

30 days after receipt from FDA.

* * * * *

6. Section 807.40 is revised to read as

follows:

§ 807.40 Establishment registration and

device listing for U.S. agents of foreign

manufacturers of devices.

(a) Each foreign device manufacturer

who exports devices into the United

States shall designate a person as their

U.S.-designated agent, who is

responsible for:

(1) Submitting MDR reports,

(2) Submitting annual certifications,

(3) Acting as the official

correspondent,

(4) Submitting registration

information,

(5) Submitting device listing

information, and

(6) Submitting premarket

notifications.

(b) The foreign manufacturer shall

provide FDA with a statement of

authorization for their U.S.-designate to

perform MDR reporting duties under

part 803 of this chapter, and to register,

list, and submit premarket notifications

under this part. The foreign

manufacturer must provide this

statement of authorization along with

the name, address, and telephone

number of the person initially

designated, or any subsequent person

designated as the U.S.-designated agent,

within 5 days of the initial or

subsequent designation. Information

shall be sent to the Center for Devices

and Radiological Health, Medical

Device Reporting, Food and Drug

Administration, P.O. Box 3002,

Rockville, MD 20847–3002.

(c) The U.S.-designated agent of a

foreign device manufacturer that exports

devices into the United States is

required to register the foreign

manufacturer’s establishments or places

of business, and to list the foreign

manufacturer’s devices, in accordance

with subpart B of this part, unless

exempt under subpart D of this part, and

to submit premarket notifications in

accordance with subpart E of this part.

The information submitted shall be in

the English language.

Dated: October 25, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–29906 Filed 12–8–95; 8:45 am]

BILLING CODE 4160–01–P

21 CFR Part 5

Delegations of Authority; Medical

Device Reporting Procedures

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulations for delegations of authority

to redelegate to certain officials in the

Center for Devices and Radiological

Health (CDRH) authorities relating to

medical device reporting procedures.

EFFECTIVE DATE: December 11, 1995.

FOR FURTHER INFORMATION CONTACT:

Kerry G. Rothschild, Center for

Devices and Radiological Health

(HFZ–84), Food and Drug

Administration, 2094 Gaither Rd.,

Rockville, MD 20850, 301–594–

4765, or

Ellen R. Rawlings, Division of

Management Systems and Policy

(HFA–340), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–

4976.

SUPPLEMENTARY INFORMATION: FDA is

amending the delegations of authority

under part 5 (21 CFR part 5) by adding

new § 5.98 Authority relating to medical

device reporting procedures. In

conjunction with CDRH’s issuance of a

medical device reporting final rule

under section 519 of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360i), the Commissioner of Food

and Drugs (the Commissioner) has

decided to delegate to certain officials in

CDRH the authority to approve

electronic reporting under 21 CFR

803.14, to request the submission of

additional information under 21 CFR

803.15, and to grant or revoke

exemptions and variances from

reporting requirements under 21 CFR

803.19. Delegation of these authorities

to the directors and deputy directors of

the Office of the Director and the Office

of Surveillance and Biometrics, CDRH,