Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Proposed Rules 42203 

(iii) Patient gender; and 

(iv) Patient weight. 

(2) Adverse experience. 

(i) Outcome attributed to adverse 

experience; 

(ii) Date of adverse experience; 

(iii) Date of report; 

(iv) Description of adverse experience; 

(v) Description of relevant tests, 

including dates and laboratory data; and 

(vi) Other relevant patient history, 

including preexisting medical 

conditions. 

(3) Suspect medical product(s). 

(i) Name; 

(ii) Dose, frequency, and route used; 

(iii) Therapy dates; 

(iv) Diagnosis for use (indication); 

(v) State whether adverse experience 

abated after product use stopped or dose 

reduced; 

(vi) Lot number; 

(vii) Expiration date; 

(viii) State whether adverse 

experience reappeared after 

reintroduction of the product; 

(ix) NDC number, or other unique 

identifier; and 

(x) Concomitant medical products and 

therapy dates. 

(4) Initial reporter information. 

(i) Name, address, and phone number; 

(ii) Whether the initial reporter is a 

health professional; 

(iii) Occupation; and 

(iv) Whether the initial reporter also 

sent a copy of the report to FDA. 

(5) Applicant information. 

(i) Applicant name and contact office 

address; 

(ii) Telephone number; 

(iii) Report source(s) (e.g., literature, 

study); 

(iv) Date received by applicant; 

(v) Application number and type; 

(vi) Type of report being submitted 

(e.g., 15-day, periodic, followup); 

(vii) Adverse experience term(s); and 

(viii) Manufacturer report number. 

(g) Electronic format for submissions. 

(1) Safety report submissions, including 

ICSRs and any attached documentation 

and the descriptive information in 

periodic reports, must be in an 

electronic format that FDA can process, 

review, and archive. FDA will 

periodically issue guidance on how to 

provide the electronic submission (e.g., 

method of transmission, media, file 

formats, preparation and organization of 

files). 

(2) Waivers. Persons subject to the 

requirements of paragraph (c) of this 

section may request, in writing, a 

temporary waiver of the requirements in 

paragraph (g)(1) of this section. These 

waivers will be granted on a limited 

basis for good cause shown. If the 

agency grants the waiver, the person 

must submit reports required under this 

section on paper within the required 

time periods in a form that FDA can 

process, review, and archive. FDA will 

issue guidance on how to provide the 

paper submission. Requests for waivers 

must be submitted in accordance with 

§ 600.90. 

* * * * * 

(i) Patient privacy. For nonvaccine 

biological products, an applicant should 

not include in reports under this section 

the names and addresses of individual 

patients; instead, the applicant should 

assign a unique code to each report. The 

preferred methodology for determining 

the identification code will be set forth 

in guidance. The applicant should 

include the name of the reporter from 

whom the information was received, 

unless the reporter is the patient. The 

names of patients, health care 

professionals, hospitals, and 

geographical identifiers in adverse 

experience reports are not releasable to 

the public under FDA’s public 

information regulations in part 20 of 

this chapter. For vaccine adverse 

experience reports, these data will 

become part of the CDC Privacy Act 

System 09–20–0136, ‘‘Epidemiologic 

Studies and Surveillance of Disease 

Problems.’’ Information identifying the 

person who received the vaccine or that 

person’s legal representative will not be 

made available to the public, but may be 

available to the vaccinee or legal 

representative. 

* * * * * 

8. Section § 600.81 is amended: 

a. By removing the phrase ‘‘licensed 

manufacturer’’ each time it appears and 

by adding in its place the word 

‘‘applicant’’; 

b. By designating the existing text as 

paragraph (a) and by adding a new 

heading for paragraph (a); and 

c. By adding new paragraph (b) to 

read as follows: 

§ 600.81 Distribution reports. 

(a) Reporting requirements. * * * 

(b)(1) Electronic format. Except as 

provided for in paragraph (b)(2) of this 

section, the distribution reports required 

under paragraph (a) of this section must 

be submitted to the agency in electronic 

format in a form that FDA can process, 

review, and archive. FDA will 

periodically issue guidance on how to 

provide the electronic submission (e.g., 

method of transmission, media, file 

formats, preparation and organization of 

files). 

(2) Waivers. An applicant may 

request, in writing, a temporary waiver 

of the requirements in paragraph (b)(1) 

of this section. These waivers will be 

granted on a limited basis for good 

cause shown. If the agency grants the 

waiver, the applicant must submit 

reports required under this section on 

paper within the required time period in 

a form that FDA can process, review, 

and archive. FDA will issue guidance on 

how to provide the paper submission. 

Requests for waivers must be submitted 

in accordance with § 600.90. 

§ 600.90 [Amended] 

9. Section 600.90 is amended by 

removing the phrase ‘‘licensed 

manufacturer’’ each time it appears and 

by adding in its place the word 

‘‘applicant’’. 

Dated: August 5, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19682 Filed 8–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 803 

[Docket No. FDA–2008–N–0393] 

RIN 0910–AF86 

Medical Device Reporting: Electronic 

Submission Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its postmarket medical device 

reporting regulation to require that 

manufacturers, importers, and user 

facilities submit mandatory reports of 

individual medical device adverse 

events, also known as medical device 

reports (MDRs) to the agency in an 

electronic format that FDA can process, 

review, and archive. Mandatory 

electronic reporting would improve the 

agency’s process for collecting and 

analyzing postmarket medical device 

adverse event information. The 

proposed regulatory changes would 

provide the agency with a more efficient 

data entry process that would allow for 

timely access to medical device adverse 

event information and identification of 

emerging public health issues. 

Elsewhere in this issue of the Federal 

Register, FDA is also announcing a draft 

guidance document that provides 

recommendations on how to prepare 

and submit electronic MDRs to FDA in 

a manner that satisfies the requirements 


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of this proposed regulation. The 

proposal also includes modifications to 

the regulations specifying the content of 

required MDRs to better track 

information already solicited on the 

FDA Form 3500A. 

DATES: November 19, 2009. Submit 

comments on information collection 

issues under the Paperwork Reduction 

Act of 1995 (the PRA) by September 21, 

2009, (see the ‘‘Paperwork Reduction 

Act of 1995’’ section of this document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2008–N– 

0393 and/or RIN number 0910–AF86, by 

any of the following methods, except 

that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously, in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and Regulatory 

Information Number (RIN) (if a RIN 

number has been assigned) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

Information Collection Provisions: 

The information collection provisions of 

this proposed rule have been submitted 

to OMB for review. Interested persons 

are requested to fax or e-mail comments 

regarding the information collection 

provisions by September 21, 2009, to 

the Office of Information and Regulatory 

Affairs, OMB. To ensure that comments 

on information collection are received, 

OMB recommends that written 

comments be faxed to 202–395–7285 or 

e-mailed to 

OIRA_submission@omb.eop.gov. Please 

reference this proposed rule and OMB 

Control Number 0910–0437 and mark 

your comments to the Attention of the 

FDA Desk Officer. 

FOR FURTHER INFORMATION CONTACT: 

Howard Press, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Building 66, rm. 3320, Silver 

Spring, MD 20993–0002, 301–796–6087. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Introduction 

A. What Are the Medical Device 

Reporting Requirements? 

1. What Are the Current Reporting 

Requirements for Manufacturers 

and What Is Their Status? 

2. What Are the Current Reporting 

Requirements for Importers? 

3. What Are the Current Reporting 

Requirements for User Facilities? 

B. What Format Is Currently Used for 

Submitting Postmarket Medical 

Device Reports? 

C. Why Is FDA Proposing to Require 

Electronic Submissions of MDRs? 

1. What Are the Options for Electronic 

Reporting? 

2. What Is the FDA Electronic 

Submission Gateway (ESG)? 

3. How Do I Know FDA Received My 

Electronic Submission and It Was 

Successfully Processed? 

II. Description of the Proposed Rule 

A. How Would the Rule Address 

Submission of Reports in Electronic 

Format? 

1. How Would the Reporting 

Requirements for Manufacturers 

Change With Respect to Electronic 

Format? 

2. How Would the Reporting 

Requirements for Importers Change 

With Respect to Electronic Format? 

3. How Would the Reporting 

Requirements for User Facilities 

Change With Respect to Electronic 

Format, and How Would Annual 

Report Requirements be Affected? 

4. How Would the Requirement to 

Submit Reports in Electronic 

Format Affect Recordkeeping 

Requirements? 

B. How Would I Submit MDRs in 

Electronic Format? 

C. How Can a Medical Device 

Manufacturer, Importer, or User 

Facility Obtain a Variance 

Regarding the Requirement to 

Submit a Report in Electronic 

Format? 

D. What Other Changes Are Being 

Proposed? 

E. When Would the Rule Become 

Effective? 

III. What Is the Legal Authority for This 

Rule 

IV. Is There an Environmental Impact? 

V. Analysis of Impacts 

A. Benefits 

B. Costs 

1. One-Time Costs 

a. Rewriting SOPs and training 

personnel 

b. Setting up systems for submission 

c. Electronic certificates 

2. Annual costs 

a. Maintaining electronic certificates 

b. High-speed Internet access 

C. Summary of Benefits and Costs 

D. Alternatives Considered 

E. Regulatory Flexibility Analysis 

VI. Paperwork Reduction Act of 1995 

A. Reporting Requirements 

B. Recordkeeping Requirements 

C. Total Annual Cost Burden 

VII. Federalism 

VIII. Request for Comments 

IX. References 

I. Introduction 

In this proposal, we provide 

background information on the current 

status of FDA’s medical device reporting 

requirements, explain the revisions we 

are proposing here, and describe our 

approach to electronic medical device 

reporting. 

For over 20 years, FDA has received 

postmarket MDRs in a paper format. 

This proposed rule to require the 

electronic submission to FDA of most 

MDRs is an important step towards 

improving the agency’s systems for 

collecting and analyzing postmarket 

MDRs. The proposed rule includes 

reports of deaths, serious injuries, and 

malfunctions that must be reported to 

FDA in initial 5-day, 10-day, or 30-day 

individual MDRs or in supplemental 

reports. We believe this proposed rule 

would have the following benefits: 

• Reduce industry’s time and costs 

associated with transcribing data from 

internal data management systems to 

paper and mailing the paper reports to 

the agency, 


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• Eliminate the agency’s transcription 

errors, time, and costs associated with 

receiving paper reports and transcribing 

data to electronic format for review and 

analysis, 

• Expedite the agency’s access to 

safety information in a format that 

would support more efficient and 

comprehensive data analysis and 

reviews, and 

• Enhance the agency’s ability to 

rapidly communicate information about 

suspected problems to the medical 

device industry, health care providers, 

consumers, and other government 

agencies. 

In addition, this proposed rule is 

consistent with the Government 

Paperwork Elimination Act (Public Law 

105–277) requirement that Federal 

agencies allow individuals or entities to 

submit information or transact business 

with the agency electronically. 

A. What Are the Medical Device 

Reporting Requirements? 

The requirements of current medical 

device reporting regulations are 

summarized in sections I.A.1 to I.A.3 of 

this document. In addition, we address 

changes to these regulations to be 

effected outside of this proposed rule. 

Current MDR regulations (part 803 (21 

CFR part 803)) require manufacturers 

and importers of marketed medical 

devices, and user facilities, to submit 

postmarket reports of individual 

medical device adverse events to FDA 

on the FDA Form 3500A. 

1. What Are the Current Reporting 

Requirements for Manufacturers and 

What Is Their Status? 

The current MDR regulation requires 

that manufacturers of medical devices 

submit a postmarket MDR of an 

individual adverse event no later than 

30 calendar days after becoming aware 

of information that a device the 

manufacturer markets may have caused 

or contributed to a death, serious injury, 

or malfunction (§ 803.50). This report 

must be submitted on the FDA Form 

3500A, (§ 803.20), and contain 

information described in § 803.52. 

In addition, the regulation requires 

manufacturers to provide supplemental 

information about such events, on an 

FDA Form 3500A, within 30 calendar 

days of obtaining information should 

such information become available after 

the initial MDR was filed with FDA 

(§ 803.56). In instances where the 

medical device adverse event resulted 

in remedial action to prevent an 

unreasonable risk of substantial harm to 

the public health, or at the discretion of 

the agency, the regulation requires the 

manufacturer to submit an MDR to the 

agency no later than 5 working days 

after becoming aware of the information 

(§ 803.53). 

Title II, section 227, of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) (Public Law 110–85), 

amended section 519 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

to require that FDA establish criteria for 

manufacturer reports of malfunctions 

for most class I and certain class II 

devices that include requiring those 

reports to be in summary form and 

made on a quarterly basis. The types of 

events required to be reported are 

unchanged. FDA intends to address 

changes necessitated by this statutory 

change separately from this proposed 

rule, and will address requirements for 

submission of those new summary 

malfunction reports at that time. 

However, some individual malfunction 

reports will continue to be required 

even after the FDAAA-related changes, 

and as explained below, the rule 

proposed here does address submission 

of individual malfunction reports to the 

agency. 

2. What Are the Current Reporting 

Requirements for Importers? 

The MDR regulation requires that 

importers of medical devices submit a 

postmarket MDR to the agency and the 

manufacturer no later than 30 calendar 

days after becoming aware of 

information that reasonably suggests 

that one of the importer’s marketed 

devices may have caused or contributed 

to a death or serious injury (§ 803.40(a)). 

Importers must submit reports to the 

manufacturer no later than 30 calendar 

days after becoming aware of 

information that reasonably suggests 

that one of the importer’s marketed 

devices has malfunctioned and that this 

device or a similar device marketed by 

the importer would be likely to cause or 

contribute to a death or serious injury if 

the malfunction were to recur 

(§ 803.40(b)). These reports must be 

submitted on the FDA Form 3500A (see 

§ 803.20) and contain the information 

specified in § 803.42. 

3. What Are the Current Reporting 

Requirements for User Facilities? 

The MDR regulation requires that user 

facilities submit a postmarket MDR of 

death to the agency and an MDR of 

death or serious injury to the device 

manufacturer within 10 working days of 

becoming aware of information that 

reasonably suggests that a device has or 

may have caused or contributed to the 

death or a serious injury of a patient of 

the facility. (§ 803.30(a)). The regulation 

requires that user facilities submit 

postmarket reports of serious injury to 

the agency within 10 working days if 

the manufacturer of the device is 

unknown or cannot be identified 

(§ 803.30(a)(2)). These reports must be 

submitted on the FDA Form 3500A (see 

§ 803.20(a)), and include the 

information described in § 803.32. 

In addition, user facilities are required 

to submit to the agency an annual 

summary of the reports they sent to 

manufacturers and the FDA, using FDA 

Form 3419 (§ 803.33). The proposal to 

require submission of reports to FDA in 

an electronic format does not apply to 

user facility annual reports made under 

§ 803.33, although other changes to 

§ 803.33 are proposed as explained in 

section I.B of this document. 

B. What Format Is Currently Used for 

Submitting Postmarket Medical Device 

Reports? 

Current regulations at § 803.20(a) 

require that user facilities, importers, 

and manufacturers use the FDA Form 

3500A to submit mandatory reports 

about FDA-regulated devices. This 

requirement took effect July 31, 1996 

(see 60 FR 63578, December 11, 1995; 

61 FR 16043, April 11, 1996). 

Certain blocks of the FDA Form 

3500A are required only for user 

facilities, while others are required only 

for manufacturers (see § 803.20(a)(2)). 

Subsequent to its initial adoption, 

FDA revised the Form 3500A and its 

instructions, adding elements including 

the premarket approval application 

(PMA) or 510(k) number for the device, 

and two questions regarding 

reprocessed single-use devices. The 

agency was required to revise the form 

to include the questions regarding 

reprocessed single-use devices under 

section 303 of the Medical Device User 

Fee and Modernization Act of 2002 

(Public Law 107–250). The revised FDA 

Form 3500A is approved under the 

PRA, under OMB control number 0910– 

0291. 

FDA Form 3500A has been routinely 

completed on paper and transmitted to 

FDA by mail, requiring FDA to 

manually input information from those 

reports into its internal electronic 

systems before it can be reviewed and 

analyzed. This process is extremely time 

consuming, costly, and susceptible to 

data entry errors. Because FDA 

regulations at § 803.14 provide for the 

possibility of voluntary electronic 

submission of MDRs, with agency 

permission, several regulations in part 

803 refer to submission of reports using 

the FDA Form 3500A ‘‘or an electronic 

equivalent approved under section 

803.14.’’ (See, e.g., §§ 803.30, 803.40, 

and 803.53.) However, reporters have 

not made use of section 803.14 to 


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42206 Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Proposed Rules 

pursue voluntary electronic submission 

of MDRs, and FDA’s legacy systems 

were not in general designed to accept 

submission of MDRs in electronic 

format. 

C. Why Is FDA Proposing to Require 

Electronic Submission of MDRs? 

When a medical device has been 

cleared for marketing and enters the 

market, the product is introduced to a 

larger patient population in settings 

different from clinical trials. New 

information generated during the 

postmarketing period offers further 

insight into the benefits or risks of the 

product, and evaluation of this 

information is important for all products 

to ensure their safe use. Historically, 

FDA has received almost all postmarket 

MDRs on paper through the mail. When 

data elements are provided to FDA on 

only paper, the information must be 

entered by hand into an electronic 

format for review and analysis. This 

process is extremely time consuming, 

costly, and susceptible to data entry 

errors. 

The electronic submission of medical 

device reports would lead to more 

efficient reviews, enhancing our ability 

to rapidly disseminate significant 

information to the medical device 

industry, health care providers, and 

consumers, in support of FDA’s public 

health mission. 

Electronic submissions would also 

improve the speed and efficiency of 

both industry and agency operations. 

Electronic reporting can benefit industry 

by reducing the costs associated with 

collating, copying, storing, retrieving, 

and mailing paper medical device 

reports to the agency on FDA Form 

3500A. In addition, the agency benefits 

from the elimination of manual data 

entry processes and reductions in 

physical storage for paper copies of the 

FDA Form 3500A. Based on low rates of 

participation in prior pilot voluntary 

electronic MDR submission programs, 

FDA believes that without a regulation 

requiring electronic submission of 

MDRs a large number of medical device 

firms and user facilities would resist 

changing their procedures for a long 

period of time. This delay would hinder 

our achieving the benefits of 

standardized formats and quicker access 

to MDR data. 

1. What Are the Options for Electronic 

Reporting? 

FDA’s Center for Devices and 

Radiological Health (CDRH) has 

established its MDR databases currently 

to support two options for electronic 

submission of MDRs: One designed for 

low volume reporting and one designed 

for high volume reporting. Both options 

make use of the FDA Electronic 

Submission Gateway (FDA ESG), a 

secure electronic portal described 

further in this document, for 

transmission of reports to FDA. In 

accordance with 21 CFR 11.2(b), CDRH 

is now accepting on a voluntary basis, 

in lieu of paper, MDRs prepared and 

transmitted in accordance with these 

options. More information on electronic 

submission of MDRs is available at 

http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

PostmarketRequirements/Reporting

AdverseEvents/ucm127932.htm. 

For low-volume medical device 

reporting (few or infrequent MDRs), the 

current approach developed by the 

agency uses the CDRH eSubmitter 

(CeSub) software. The CeSub software 

allows for the submission of one MDR 

at a time. The software provides the 

following tools: 

• Save address and contact 

information, 

• Search for a Product Code, 

• Search to locate a patient or Device 

Problem Code, 

• Search to find manufacturer 

evaluation codes (method, result, and 

conclusion), 

• Attach documents when additional 

information needs to be provided, 

• Produce a ‘‘missing data report’’ to 

help ensure that all required 

information is supplied before 

submission to FDA. 

Once the MDR is completed, the file 

is ‘‘packaged for submission.’’ The 

package generates an electronic version 

of the FDA Form 3500A, which can be 

submitted to FDA using the FDA ESG. 

The final CeSub-generated report can 

also be saved or printed, for 

recordkeeping or to provide reports to 

manufacturers or other entities outside 

of FDA. The CeSub software and 

instructions for installation are free and 

available at: http://www.fda.gov/ 

ForIndustry/FDAeSubmitter/ 

ucm107903.htm. We may sometimes 

update or change our methodology, 

approach or software to improve the 

low-volume reporting experience. 

Reporters with large volumes of MDRs 

may prefer the second option, called the 

Health Level 7 Individual Case Safety 

Report (HL7 ICSR). The HL7 ICSR was 

developed in conjunction with the HL7 

standards organization to support the 

exchange of electronic data. This option 

allows for the extraction directly from 

the reporter’s database of information to 

populate an MDR, production of the 

appropriate data output, and 

transmission of the MDRs to the FDA 

ESG. The HL7 ICSR supports the batch 

submission of more than one individual 

MDR at a time. Reporters developing 

applications using the HL7 ICSR 

standard may also build functions for 

saving or printing those reports. 

The draft guidance document 

announced elsewhere in this Federal 

Register provides information on both 

options for electronic submission of 

MDRs. 

2. What Is the FDA Electronic 

Submission Gateway (ESG)? 

The FDA ESG is the entry point for all 

electronic submissions to the agency. 

The FDA ESG is available 24 hours a 

day, 7 days a week. Information on the 

FDA ESG is available at http:// 

www.fda.gov/ForIndustry/Electronic

SubmissionsGateway/default.htm. To 

use the FDA ESG, reporters need to have 

a digital certificate. A digital certificate 

is an attachment to an electronic 

message that allows the recipient to 

authenticate the identity of the sender 

via third party verification from an 

independent certificate authority. 

Digital certificates are used to identify 

encryption and decryption codes 

between message senders and 

recipients. Information on digital 

certificates can be found at http:// 

www.fda.gov/ForIndustry/Electronic

SubmissionsGateway/ucm113223.htm. 

3. How Do I Know FDA Received My 

Electronic Submission and It Was 

Successfully Processed? 

FDA’s electronic submission 

processing system sends the submitter 

three different acknowledgments 

(messages) for each submission. 

Acknowledgment 1 comes from the ESG 

and indicates your submission was 

received. Acknowledgment 2 is sent by 

the ESG and indicates the submission 

reached CDRH. CDRH sends 

Acknowledgment 3 and notifies you 

whether your submission was 

successfully loaded into CDRH’s 

adverse event database or the 

submission contained errors (specified 

in the acknowledgment) during 

validation and loading. If your 

submission contained errors, the errors 

need to be corrected and the corrected 

reports resent. 

II. Description of the Proposed Rule 

A. How Would the Rule Address 

Submission of Reports in Electronic 

Format? 

This rule would revise § 803.12 to 

require that manufacturers, importers, 

and user facilities submit postmarket 

MDRs to the agency in an electronic 

format that FDA can process, review, 

and archive. Under the proposal, FDA 

will periodically issue information on 


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file formats, preparation and 

organization of files, media, method of 

transmission, and other relevant 

technological specifications for 

providing reports in an electronic 

format that FDA can process, review, 

and archive. Proposed new § 803.23 

would direct reporters to the agency’s 

Web site to find the most updated 

relevant information. Reports between 

manufacturers, importers, and user 

facilities would not be subject to the 

requirement of submission in electronic 

format, and may be in any format the 

recipient can read. 

The rule would make conforming 

changes throughout part 803 to reflect 

the proposed requirement to submit 

reports to FDA in electronic format. 

These changes include removing 

§ 803.11, which currently addresses 

obtaining paper forms, and removing 

§ 803.14, which currently provides for 

voluntary electronic submission of 

reports with FDA consent. The proposal 

would amend § 803.19, which already 

addresses exemptions or variances from 

any of the requirements of part 803, to 

specifically address exemption or 

variance from the requirement to submit 

reports to FDA in electronic format. 

Other changes include removing 

references to ‘‘electronic equivalent[s] 

approved under § 803.14’’ from 

§§ 803.13, 803.30, 803.33, 803.40, and 

803.53, and updating wording in 

§ 803.20 and 803.56 to be more 

consistent with the fact that reports will 

not be submitted on paper (and thus, for 

example, would no longer have a front 

and back). 

If this proposed rule becomes final, 

manufacturers, importers, and user 

facilities would be required to begin 

submitting medical device reports to the 

agency in electronic format no later than 

1 year from the date of publication of a 

final rule. After the effective date, the 

agency would not accept MDRs 

submitted on paper copies of the FDA 

Form 3500A, or in electronic formats 

other than those identified as ones that 

FDA can process, review, and archive in 

information provided in conjunction 

with this rule, unless the agency had 

granted an exemption or variance as 

provided for in § 803.19. 

1. How Would the Reporting 

Requirements for Manufacturers Change 

With Respect to Electronic Format? 

The rule would amend §§ 803.50(a), 

803.53, and 803.56 to require 

submission of information required by 

§§ 803.52, 803.53, and 803.56 in 

electronic format in accordance with 

§ 803.12(a). 

2. How Would the Reporting 

Requirements for Importers Change 

With Respect to Electronic Format? 

The proposed rule amends § 803.40(a) 

to require submission to FDA of 

information required by § 803.42 in 

electronic format in accordance with 

§ 803.12(a). The proposed electronic 

format requirement does not extend to 

importer reports submitted to device 

manufacturers, which may be in any 

format that the recipient can read. 

3. How Would the Reporting 

Requirements for User Facilities Change 

With Respect to Electronic Format, and 

How Would Annual Report 

Requirements be Affected? 

The proposed rule amends § 803.30(a) 

to require submission to FDA of 

information required by § 803.32 in 

electronic format in accordance with 

§ 803.12(a). The amendment does not 

impose mandatory electronic format 

requirements on user facility reports 

submitted to device manufacturers, 

which may be provided in any format 

the recipient can read. 

The proposed rule also makes certain 

changes to § 803.33, addressing user 

facility annual reports. Under the 

proposed rule, user facilities will 

continue to submit annual reports on 

the paper FDA Form 3419. Because the 

proposal to require submission of 

individual adverse events reports in 

electronic format calls for amendments 

to § 803.12 and for removal of §§ 803.11 

(indicating how to obtain paper forms) 

and 803.14 (addressing voluntary 

electronic submissions), FDA is 

proposing to amend § 803.33 to specify 

where to obtain the FDA Form 3419, 

where to submit completed reports 

under that section, and to remove 

references to § 803.14. 

4. How Would the Requirement to 

Submit Reports in Electronic Format 

Affect Recordkeeping Requirements? 

Section 803.18 of the regulation 

addresses requirements for establishing 

and maintaining MDR files or records 

for manufacturers, user facilities, and 

importers. FDA is proposing to amend 

§ 803.18(b)(ii) to require that MDR files 

contain copies of all reports submitted 

under part 803, whether paper or 

electronic. As under the current 

regulations, under the proposal, 

regulated entities may choose to 

maintain required records either in hard 

copy, by printing out reports submitted 

in electronic format, or in electronic 

form. (For information regarding FDA’s 

current thinking and enforcement policy 

with regard to requirements for 

maintaining electronic records, see 21 

CFR part 11 and the agency guidance 

document, ‘‘Guidance for Industry: Part 

11, Electronic Records; Electronic 

Signatures—Scope and Application,’’ 

available at http://www.fda.gov/ 

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

ucm072322.pdf5667fnl.pdf.). FDA is 

also proposing to add § 803.18(b)(1)(iii) 

to require the retention of all 

acknowledgments FDA sends the 

manufacturer, importer, or user facility 

when reports are submitted in electronic 

format, which will indicate the timing 

and success of submission. 

B. How Would I Submit MDRs in 

Electronic Format? 

As noted previously, if the proposed 

rule is finalized, manufacturers, 

importers, and user facilities will be 

required to submit most MDRs to the 

agency in an electronic format that FDA 

can process, review, and archive. In 

order to best accommodate 

technological changes, FDA expects to 

issue information on how to prepare 

and submit MDRs to the agency in a 

way that would satisfy the requirements 

of this proposed rule. The most specific 

and updated information about how to 

create, format, and transmit reports, 

using the CeSub software (designed for 

low volume reporting) or the HL7 ICSR 

(designed for high volume reporting), is 

provided on the agency’s Web site, at 

the address provided in proposed 

§ 803.23. The agency will make every 

effort to maintain backwards 

compatibility when implementing 

changes to the systems and formats for 

electronic submission. When backwards 

compatibility is not possible, the agency 

will provide public notice with a 

duration commensurate with the 

complexity of the change. 

C. How Can a Medical Device 

Manufacturer, Importer, or User Facility 

Obtain a Variance Regarding the 

Requirement to Submit a Report in 

Electronic Format? 

Under proposed § 803.19, a 

manufacturer, importer, or user facility 

may submit a written request to FDA 

seeking a variance of the § 803.12 

requirement to submit reports to the 

agency in an electronic format that the 

agency can process, review, and archive. 

Written requests must contain the 

reason(s) why the reporting entity 

requires a variance and for how long the 

variance is needed. FDA anticipates 

receiving few variance requests because 

of the availability of the Internet and the 

commercial availability of digital 

certificates as well as FDA’s free CeSub 

Internet software. Under the proposal, if 

FDA grants a variance, the 


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manufacturer, importer, or user facility 

would be required to submit MDRs as 

specified by FDA in the letter 

authorizing the variance. 

D. What Other Changes Are Being 

Proposed? 

The proposed rule would also codify 

the following modifications: 

1. FDA proposes to remove the 

definition of ‘‘Five-day report’’ in 

§ 803.3, which merely referred to a 

report submitted under § 803.53 (the 

only provision of the regulation in 

which the term appears), using the FDA 

Form 3500A or ‘‘an electronic 

equivalent approved under § 803.14.’’ 

Because this definition is not necessary, 

FDA proposes to remove it. 

2. FDA proposes to amend §§ 803.32, 

803.42, and 803.52 to make minor 

wording changes and corrections to 

these sections to reflect modifications 

already made to FDA Form 3500A and 

its instructions, with OMB approval 

under the PRA. For example, section 

303 of the Medical Device User Fee and 

Modernization Act of 2002 (Public Law 

107–250) required FDA to modify the 

forms to facilitate reporting of MDRs 

involving single-use devices that have 

been reprocessed for reuse (see 69 FR 

7491, February 17, 2004). FDA is 

proposing to amend §§ 803.32, 803.42, 

and 803.52 to reflect the addition to the 

FDA Form 3500A of these two questions 

concerning whether the device is a 

single use device that has been 

reprocessed and reused on a patient and 

the name and address of the 

reprocessor. 

FDA is also proposing to change 

§§ 803.32(b)(4), 803.42(b)(4), and 

803.52(b)(4) from ‘‘date of report by the 

initial reporter’’ to ‘‘date of this report.’’ 

This change would make part 803 

consistent with the way that other FDA 

Centers interpret FDA Form 3500A, 

Block B4 and how Block B4 appears on 

FDA Form 3500A. Finally, FDA is also 

proposing to make other minor updates 

to §§ 803.32(c), 803.42(c), and 803.52(c) 

and (e) to reflect the changes already 

made to the forms and instructions, 

including a reference to the product 

code and PMA/510(k) number. 

E. When Would the Rule Become 

Effective? 

FDA proposes that any final rule that 

issues based on this proposal become 

effective 1 year after the date the final 

rule publishes in the Federal Register. 

III. What Is the Legal Authority for This 

Rule? 

FDA’s legal authority to amend its 

regulations governing the submission of 

postmarket medical device adverse 

event reports for medical devices 

derives from 21 U.S.C. 352, 360, 360i, 

360j, 371, and 374. 

IV. Is There an Environmental Impact? 

The agency has determined under 21 

CFR 25.30(h) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

V. Analysis of Impacts 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866 and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). 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). This proposed rule 

has been determined to be a significant 

regulatory action. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because we lack information on 

the electronic submission capabilities of 

all the firms potentially affected by this 

proposed rule we have not proposed to 

certify that the proposed rule would not 

have a significant economic impact on 

a substantial number of small entities. 

We request commenters to submit such 

information in their comments. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $133 

million, using the most current (2008) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any 1- 

year expenditure that will meet or 

exceed this amount. 

The purpose of this proposed rule is 

to require the submission of MDRs in an 

electronic format the agency can 

process, review, and archive. It would 

affect all persons subject to medical 

device reporting under part 803, which 

includes medical device manufacturers, 

device importers, and user facilities. 

The proposed rule is part of a greater 

agency initiative to adopt electronic 

technologies to improve the quality of 

our operations and increase the 

efficiency of our resources. The rule 

would reduce FDA’s current costs 

associated with processing medical 

device reports (or MDRs) that are 

received on the paper FDA Form 3500A. 

By receiving MDRs electronically, FDA 

would be able to access the adverse 

event information more quickly and also 

eliminate potential data entry errors that 

could occur during input transcription 

of the information from the paper FDA 

Form 3500A reports into our electronic 

medical device adverse event reporting 

database. 

After considering various alternatives, 

FDA determined that without this 

regulation, the agency will need to 

maintain adequate resources to continue 

to convert paper 3500A MDRs to 

electronic MDR records until all 

manufacturers, importers, and user 

facilities voluntarily adopted the 

proposed electronic submission format, 

possibly years in the future. 

A. Benefits 

The major benefit of this proposed 

rule would be to public health because 

the agency would have quicker access to 

the medical device adverse event 

reports information and thus could 

more quickly identify and act on any 

medical device problems. Currently, 

FDA receives 100,000 initial MDRs 

annually on the paper FDA Form 

3500A, which are manually entered into 

the FDA database. FDA receives an 

additional 110,000 supplemental reports 

each year that are also submitted on the 

paper FDA Form 3500A and need to be 

processed and entered into the FDA 

database. It can take from 3 days to more 

than 6 months before an MDR submitted 

on a paper copy of the FDA Form 3500A 

may be available for analysis in the 

Manufacturer and User Device 

Experience database (MAUDE). With a 

standardized electronic format, medical 

device reports would become available 

for analysis as soon as they are 

processed into MAUDE. With a 

reduction in the time to manually enter 

the MDRs into the MAUDE database, 

analysis and action, including feedback 

to manufacturers and consumers, could 

be taken sooner with a corresponding 

benefit to public health. 

The public health benefits would be 

supplemented with operating cost 

reductions within FDA. Assuming the 

number of MDRs remains fairly constant 

over time, electronic reporting would 


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1Percentages are based on the ratio of firms to 

establishments from 2002 Census of Manufactures 

data. 

2 $52 per hour wage is based on BLS 

Occupational Employment and Wages, May 2006, 

for Medical and Health Service Managers, Standard 

Occupational Classification 11–19111. Forty 

percent was added to the mean hourly wage of 

$37.09 to account for benefits and the total was 

rounded to the nearest whole number. 

3BLS Occupation Employment and Wages, May 

2006, by occupation, for all industries (http:// 

www.bls.gov). Wage ($46.50) includes mean hourly 

wage of $33.22 for Standard Occupational 

Classification 15–0000, computer and mathematics 

occupations, all industries; we add 40 percent to 

account for benefits. 

save the agency about $1.25 million 

annually in data entry costs, which is 

about one-half of our current data entry 

contract. 

B. Costs 

There are about 18,000 medical 

device manufacturers and importers 

identified in FDA’s medical device 

registration database and approximately 

38,500 user facilities identified in the 

2002 U.S. Economic Census that would 

be affected by the proposed rule (for a 

total of 56,500 manufacturers, 

importers, and user facilities) (Census, 

2002). Table 1 shows the estimated 

numbers of firms and establishments in 

the affected industries. 

TABLE 1.—AFFECTED FIRMS AND ESTABLISHMENTS

North American Industry Classification System 

(NAICS) Code Description No. of Firms No. of Establishments 

Various Devices 18,000 8,000 

622 Hospitals 3,800 6,342 

6231 Nursing care facilities 7,826 15,480 

6214 Outpatient care centers 11,125 23,912 

6215 Medical and diagnostic laboratories 5,736 9,844 

6216 Home health care services 9,987 15,016 

Total 56,474 88,594 

The incremental cost of changing to 

electronic submissions for each affected 

entity would vary by the size, type, and 

corporate structure of the firm, as well 

as by its current electronic submission 

capability. The total costs associated 

with this proposed rule would include 

one-time set-up costs and annual 

operating costs. 

1. One-Time Costs 

One-time costs would be the sum of 

the costs of: 

• Rewriting standard operating 

procedures (SOPs) and training the 

appropriate personnel, 

• Installing and validating either the 

installation of CDRH’s CeSub Web 

interface software or the programming 

and configuration of a computer system 

to transmit reports directly to the FDA 

ESG using the HL7 ICSR, and 

• Acquiring the electronic digital 

certificate required by the FDA ESG. 

a. Rewriting SOPs and training 

personnel. All entities affected would 

need to update their SOPs to include the 

electronic submission requirement. For 

medical device manufacturers, 

importers, and hospitals, we estimate 

that it would require about 10 hours to 

make the modifications and train the 

appropriate people on the new 

procedures. For the other user facilities, 

we assume that the corporate or regional 

offices would have the major 

responsibility for medical device 

reporting and thus the SOPs for these 

individual entities would require less 

time to modify. For this analysis we 

estimated that 55 percent of the other 

user facilities would require about 10 

hours to modify their SOPs and the 

remaining 45 percent would require 

about 2 hours.1 The estimated one-time 

incremental cost for updating SOPs, 

assuming an average wage rate of $52 

per hour,2 (Bureau of Labor Statistics 

(BLS), 2006) is about $34.1 million 

[((18,000 medical device manufacturers 

and importers + 6,300 hospitals) x 10 

hours) + ((0.45 x 2 hours + 0.55 x 10 

hours) x 64,500 other user facilities) x 

$52/hour]. 

b. Setting up systems for submission. 

MDRs would be submitted through the 

FDA ESG using one of two methods: 

The CDRH CeSub software or the HL7 

ICSR. Because most entities are small 

and submit few if any MDRs annually, 

we assume they would probably use the 

CDRH CeSub software, which allows for 

the submission of one MDR at a time. To 

comply using this submission method, 

manufacturers, importers, and user 

facilities would need high-speed 

Internet connections and would have to 

download and install up to three free 

software programs, validate the 

installation, and train the appropriate 

personnel on the new procedures. 

Entities that have dedicated information 

technology (IT) staff would be able to 

install and validate the installation 

themselves. Smaller manufacturers, 

importers, and user entities would 

probably choose to hire an outside 

contractor for the installation and its 

validation. 

We do not have data on the amount 

of time required to install and validate 

the installation of the software or the 

percentage of entities that might need to 

contract out the installation. For this 

analysis, we assumed it would take an 

entity 8 to 16 hours to install and 

validate the installation of CDRH’s 

CeSub software and install, if necessary, 

Java Runtime Edition software and Java 

security policy files for their Internet 

browser. This estimate also includes the 

time required to notify FDA, run a test 

submission through the FDA ESG, and 

to train the appropriate staff to use the 

new program. We are also assuming that 

almost all medical device 

manufacturers, importers, and all user 

facilities would use this method to 

submit MDRs. Using an average wage of 

$46.50 for computer and mathematical 

occupations3 (BLS 2006), we estimate 

the cost to install and use the software 

to be between $21.0 million and $41.7 

million [(8 hours x $46.50 wage) x 

(38,500 user facilities + 18,000 

manufacturers and importers) to (16 

hours x $46.50 wage) x (38,500 user 

facilities + 18,000 manufacturers and 

importers)]. 

Entities that submit a large number of 

MDRs each year may choose to use the 

HL7 ICSR method to submit the reports. 


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This method allows for the batch 

submission of multiple MDRs at faster 

transmission rates. We do not know at 

what threshold of reporting it becomes 

cost effective for an entity to submit 

medical device reports using this 

method. An analysis of FDA submission 

data for a 6-year period indicated that 

about 20 large medical device 

manufacturers submit 500 or more 

MDRs each year and about 85 submit 

close to 100 medical device reports per 

year. We assumed that the actual 

number of entities using the HL7 ICSR 

would fall somewhere within this range 

(20 to 85). We also assumed that only 

entities that have existing infrastructure 

to support HL7 ICSR transmissions 

would choose this method to submit 

MDRs. We estimated that it would take 

about 50 hours to set up their gateway 

to be compatible with the agency’s 

system. Using the wage $46.50, the onetime cost for establishing HL7 ICSR 

submission capabilities would range 

between $50 thousand and $200 

thousand [($46.50 x 50 hours) x 20 

entities) and ($46.50 x 50 hours) x 85 

entities)]. 

c. Electronic certificates. All entities 

would need an electronic certificate to 

submit any electronic regulatory 

document to the FDA ESG. The 

electronic certificate identifies the 

sender and serves as an electronic 

signature. Entities that have not 

submitted any electronic documents to 

the agency would incur a one-time cost 

to acquire the certificate and recurring 

costs to keep the certificate active as a 

result of this proposed rule. The 

certificates cost about $20 and are valid 

for 1 year. We assume that the search 

and transactions costs involved in the 

initial acquisition of the certificate 

doubles the cost of the certificate to a 

total of $40 for the first year, half of 

which would be setup costs. If all 

entities needed to acquire electronic 

certificates, the one-time search and 

acquisition costs would be $1.1 million 

($20 acquisition cost x 56,500 entities). 

In addition to the costs we have 

estimated, manufacturers, importers, 

and user facilities affected by this 

proposed rule may have to hire outside 

expertise to install and validate the 

software installation to comply with the 

proposed requirements. 

Table 2 summarizes the estimated 

one-time costs by type of cost for this 

proposed rule by cost and type of 

manufacturers, importers, and user 

entities. The estimate of the total onetime costs for all manufacturers, 

importers, and user facilities ranges 

from $58.6 million to $79.7 million. 

Much of the cost involves acquiring the 

electronic certificate for the capability to 

submit any regulatory document to the 

FDA, including installation and 

validation of the CeSub software or to 

establish HL7 ICSR capabilities. 

Therefore, manufacturers, importers, 

and user facilities that are not already 

making electronic submissions of any 

kind to the agency if this proposed rule 

becomes final would incur these total 

costs. 

TABLE 2.—SUMMARY OF ONE-TIME COSTS BY INDUSTRY ($ MILLION) 

Industry Modifying 

SOPs 

Install and validate CeSub 

software 

Gateway to gateway 

Acquiring ecertificate 

Total 

low high low high low high 

Medical Device 9 .4 6 .7 13 .4 0 .05 0 .2 0 .4 16 .6 23 .4 

User Facility 26 .9 14 .3 28 .6 0 .8 42 .0 56 .3 

Total 36 .3 21 .0 42 .0 0 .05 0 .2 1 .2 58 .6 79 .7 

Annualized at 3 percent over 10 years 6 .9 9 .3 

Annualized at 7 percent over 10 years 8 .3 11 .4 

2. Annual Costs 

The annual costs of this proposed rule 

would include the costs of: 

• Maintaining certificates and 

• High-speed Internet access. 

a. Maintaining electronic certificates. 

Manufacturers, importers, and user 

facilities would bear the cost to 

maintain the electronic certificate that 

identifies the sender. In addition to 

having to renew the certificate on a 

regular basis, those entities who have 

not submitted MDRs would also have to 

ensure they are capable of transmitting 

electronic MDRs to FDA should such a 

report submission be necessary. To add 

these costs to the cost of the certificate 

itself, we assume that entities would 

incur an additional annually recurring 

cost equal to one-half the price of the 

certificate ($10), for a total annually 

recurring cost of $30. If all 

manufacturers, importers, and user 

facilities need to acquire electronic 

certificates, the annual cost would be 

$1.7 million ($30 acquisition certificate 

renewal and acquisition cost x 56,500 

entities). 

b. High-speed Internet access. Entities 

would also need high-speed Internet 

access to use either of the submission 

methods. A 2004 study of small 

businesses sponsored by the Small 

Business Administration (SBA) found 

that essentially all small firms had 

Internet access and about 50 percent 

had high-speed Internet access (Pociask, 

2004). The average cost of high speed 

access was about $40 per month more 

than dial-up access. Because the average 

cost of Internet access has been going 

down over time, we estimate that by the 

time this proposed rule would be made 

final, about 75 percent of device and 

user facilities would have high speed 

access. The average annual recurring 

increase in cost for high speed Internet 

access for the remaining 25 percent of 

the entities would be $6.8 million (($40 

x 12 months) x (0.25 x (18,000 

manufacturers and importers + 38,500 

user facilities))). 

Table 3 shows the annual costs of the 

proposed rule. As with the one-time 

costs, only entities not making 

electronic regulatory document 

submissions of any kind to the agency 

if this proposed rule becomes final 

would incur all these costs. There 

would be no change in the actual time 

required to research and prepare the 

MDRs, nor would there be any 

additional reporting requirements as a 

result of this proposed rule. 

Manufacturers, importers, and user 

facilities that maintain paper FDA Form 

3500A records for their internal MDR 

files own use could still do so under the 

proposed rule. 


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Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Proposed Rules 42211 

4U.S. Census Bureau, 2002 Economic Census, 

Manufacturing Industry Series, Industry Statistics 

by Employment Size for NAICS codes: 334510, 

339112, 339113, 339114, and 339115 

(www.census.gov). 5U.S. Census Bureau, 2002 Economic Census, 

Release Date 11/22/2005, Sector 62: Health Care 

and Social Assistance: Subject Series— 

Establishment and Firm Size: Receipts/Revenue 

Size the United States for NAICS 622, 6231, 6214, 

6215, and 6216 accessed via American Fact Finder 

(www.census.gov). 

TABLE 3.—SUMMARY OF ANNUAL COSTS BY INDUSTRY ($ MILLION) 

Industry Acquiring electronic 

certificate 

High-speed Internet 

access Total 

Medical Device 0 .5 2 .2 

User Facility 1 .2 4 .6 

Total 1 .7 6 .8 8 .5 

Cost savings: We estimate a modest 

industry savings of about $3.2 million 

annually because electronic submission 

should reduce the time it takes to 

submit documents. It should be noted 

that the savings accumulate to firms 

submitting MDRs; firms that submit 

very few or no MDRs would not realize 

any savings. 

C. Summary of Benefits and Costs 

The principal benefit of this proposed 

rule would be the public health benefits 

associated with more rapid processing 

and analysis of the 100,000 initial 

individual MDRs currently submitted to 

FDA on a paper FDA Form 3500A. In 

addition, requiring electronic 

submission of MDRs is expected to 

reduce FDA annual operating costs by 

$1.25 million and generate industry 

savings of about $3.2 million. 

The total one-time cost for modifying 

SOPs and establishing electronic 

submission capabilities is estimated to 

range from $58.6 million to $79.7 

million. Annually recurring costs 

totaled $8.5 million and include 

maintenance of electronic submission 

capabilities, including renewing the 

electronic certificate, and for some 

entities the incremental cost to maintain 

high-speed Internet access. The total 

annualized cost of the proposed rule, 

assuming a 7-percent discount rate over 

10 years, would be from $16.8 million 

to $19.9 million ($15.4 million to $17.8 

million at a 3-percent discount rate). We 

request comment on the accuracy and 

completeness of the assumptions used 

to estimate the costs of this proposed 

rule. For example, we invite comment 

on our use of a 10-year time horizon and 

whether a shorter or a longer horizon 

would be more appropriate to express 

the social costs of this proposed rule. 

D. Alternatives Considered 

During the development of this 

proposed rule, we considered a number 

of alternative approaches. The first was 

to allow manufacturers, importers, and 

user facilities to voluntarily submit 

MDRs electronically. Because our 

experience has shown that a number of 

medical device firms and user facilities 

would resist changing their procedures 

for a long period of time, we would not 

attain the benefits of standardized 

formats and quicker access to medical 

device adverse event data. The FDA, for 

example, would have to maintain 

contracts to handle the input of 

information from both written and 

electronic MDRs. A voluntary system, 

therefore, would fail to achieve the goals 

of this proposed rule. 

Another alternative was to allow 

small entities more time to comply with 

the electronic submission requirements. 

This alternative would allow small 

entities to delay compliance. Under this 

alternative, we would not receive the 

full data-entry savings from requiring 

electronic submissions or all the 

benefits of quicker access to these 

reports. Because so many device 

companies are small entities, this 

approach would significantly postpone 

the benefits the rule is intended to 

confer. Moreover, as shown in the 

following section, the estimated 

incremental costs per small entity from 

the proposed rule are small, so the cost 

reduction per small entity from delayed 

compliance would also be small. 

E. Regulatory Flexibility Analysis 

The SBA defines a small medical 

device manufacturer as having fewer 

than 500 employees. Based on data from 

U.S. Census, about 98 percent of device 

firms affected by this proposed rule are 

considered small entities, and have an 

average value of shipments of about $9.0 

million.4 Businesses in the health care 

industry are classified as small if their 

revenues are below a certain level. 

Hospitals are small if their total revenue 

falls below $25 million and the other 

user facilities are considered small if 

their revenues are below $10 million. 

U.S. Census data indicates that about 87 

percent of the user facilities are 

classified as small and have a weighted 

average revenue of about $3.3 million.5

However, very few user facilities submit 

MDRs in any given year. While this 

proposed rule will now require those 

reports submitted to the agency to be in 

electronic format, the content of a report 

is not being changed from that already 

addressed on the current FDA Form 

3500A. The average costs for these 

manufacturers, importers, and user 

facilities are listed in table 4. The 

average total annualized cost per small 

entity, assuming a 7-percent discount 

rate over 10 years, would range from 

$581 to $693; at a 3-percent discount 

rate, average annualized costs would 

range from $568 to $661. These costs 

represent less than 0.1 percent of 

revenues for medical device firms and 

less than 0.1 percent of revenues for 

user facilities. 

We considered two possible 

alternatives for regulatory relief for 

small businesses. As described above, 

one regulatory alternative would be 

longer compliance times for small 

entities. We would not receive the full 

data-entry savings from requiring 

electronic submissions or all the 

benefits of quicker access to these 

reports. Because so many device 

companies are small entities, this 

approach would significantly postpone 

the benefits the rule is intended to 

confer. Moreover, as shown above, the 

estimated incremental costs per small 

entity from the proposed rule are small, 

so the cost reduction per small entity 

from delayed compliance would also be 

small. 

In addition, we considered proposing 

a waiver to the electronic submission 

requirement for small firms that can 

demonstrate an economic hardship. 

Because the estimated incremental costs 

per small entity from the proposed rule 

are small, the cost reduction per small 

entity from a waiver would also be 

small. 

We ask for comments on both of these 

options for regulatory relief for small 

entities. 

While the estimated costs per affected 

entity are low, FDA does not have 

adequate information on the electronic 

capabilities of all of the firms affected 


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by this proposed rule and has made 

many assumptions to derive these 

estimate used in this analysis, therefore 

we do not propose to certify that this 

proposed rule would not have a 

significant economic impact on a 

substantial number of small entities. 

FDA requests comment on this issue. 

TABLE 4.—INCREMENTAL COMPLIANCE COSTS PER SMALL ENTITY

One-Time 

Costs Annually 

Recurring 

Total 

Annualized 

low high low high 

Rewriting SOPs 104 520 

Software Installation and validation of installation 372 744 

Acquiring Electronic Certificate 40 

Maintaining submission capabilities 30 

Upgrade Internet Access 480 

7 percent discount rate 581 693 

3 percent discount rate 568 661 

VI. Paperwork Reduction Act of 1995 

This proposed rule contains 

information collection provisions that 

are subject to review by OMB under the 

PRA (44 U.S.C. 3501–3520). A 

description of these provisions is given 

in this document with an estimate of the 

annual reporting and recordkeeping 

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 

each collection of information. 

FDA invites comments on these 

topics: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Medical Device Reporting 

Description: In accordance with the 

proposed Medical Device Reporting 

regulation, medical device 

manufacturers, importers, and user 

facilities would be required to submit 

MDRs to FDA, to maintain records, and 

may also seek exemption or variance 

from these requirements. FDA is also 

proposing to amend §§ 803.32, 803.42, 

and 803.52 to make minor wording 

changes and corrections to these 

sections to reflect modifications already 

made to FDA Form 3500A and its 

instructions. Manufacturers, importer, 

and user facilities are currently 

submitting paper MDR reports on FDA 

Form 3500A. The existing information 

collection for part 803 is approved 

under OMB control number 0910–0437. 

The changes to the burden associated 

with this proposed rule are described 

below and have been sent to OMB as a 

revision to OMB control number 0910– 

0437 for review under section 307(d) of 

the PRA. 

Section 519(a)(1) of the act (21 U.S.C. 

360i(a)(1)) requires every manufacturer 

or importer to report ‘‘whenever the 

manufacturer or importer receives or 

otherwise becomes aware of information 

that reasonably suggests that one of its 

marketed devices— 

(A) may have caused or contributed to 

a death or serious injury, or 

(B) 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 * * *’’ 

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

requires ‘‘whenever a device user 

facility receives or otherwise becomes 

aware of information that reasonably 

suggests that a device 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 working days after becoming aware 

of the information, report the 

information to the Secretary and, if the 

identity of the manufacturer is known, 

to the manufacturer of the device.’’ 

Section 519(b)(1)(B) of the act requires 

‘‘whenever a device user facility 

receives or otherwise becomes aware of: 

(i) information that reasonably suggests 

that a device has or may have caused or 

contributed to the serious illness of, or 

serious injury to, a patient of the facility 

* * *, shall, as soon as practicable but 

not later than 10 working days after 

becoming aware of the information, 

report the information to the 

manufacturer of the device or to the 

Secretary if the identity of the 

manufacturer is not known.’’ 

Complete, accurate, and timely 

adverse event information is necessary 

for the identification of emerging device 

problems so the agency can protect the 

public health under section 519 of the 

act. FDA is requesting approval for the 

information collection requirements 

contained in part 803. 

Description of Respondents: 

Manufacturers and importers of medical 

devices and device user facilities. 

Device user facility means a hospital, 

ambulatory surgical facility, nursing 

home, outpatient diagnostic facility, or 

outpatient treatment facility as defined 

in § 803.3, which is not a physician’s 

office (also defined in § 803.3). 

The total annual estimated burden 

imposed by this collection of 

information is 21,525 hours annually. 


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TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR 

Section 

FDA 

Form No. 

No. of 

Respondents 

Annual Frequency 

Per Response 

Total Annual 

Responses 

Hours per 

Response 

Total 

Hours 

803.19 55 4 220 1 220 

803.30 and 809.32 411 2 822 0.33 271 

803.33 3419 411 1 411 1 411 

803.40 and 803.42 44 20 880 0.33 290 

803.50 and 803.52 1,304 58 75,632 0.11 8,248 

803.56 1,200 48 57,600 0.10 5,760 

Total 15,200 

TABLE 6.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR 

Section 

No. of 

Respondents 

Frequency per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

803.17 1,677 1 1,677 3 .3 5,534 

803.18 (a) to (d) 527 1 527 1 .5 791 

Total 2,204 2,204 6,325 

The approved MDR reporting and 

recordkeeping burden for paper 

submissions is 138,271 hours. This 

proposed rule reporting and 

recordkeeping burden for electronic 

submissions is 21,525 hours, a decrease 

of 123,071 hours. Based on an average 

wage rate of $46.50 per hour, the total 

cost to respondents associated with 

these reporting and recordkeeping 

burdens is $1,000,913. An explanation 

for the burden decrease is provided 

below. 

A. Reporting Requirements 

The number of respondents for each 

Code of Federal Regulations (CFR) 

section in table 5 is based upon the 

number of respondents entered into 

FDA’s internal databases. FDA estimates 

that electronic submission will decrease 

the burden associated with §§ 803.19, 

803.30, 803.32, 803.40, 803.50, 803.52, 

and 803.56. We believe electronic 

submission will neither increase nor 

decrease burden associated with 

§ 803.33, which we estimate will take 1 

hour. We believe § 803.19 will take 1 

hour, while §§ 803.30, 803.32, 803.40, 

and 803.42 will take 20 minutes. 

Sections 803.50 and 803.52 will take 7 

minutes. Section 803.56 will take 6 

minutes. The following table 

summarizes our burden estimates and 

how we believe they will change due to 

electronic submission. 

TABLE 7.—ESTIMATED REPORTING BURDEN PROGRAM CHANGE

21 CFR Section 

Hours per response 

under current paper 

submission process 

Hours per response 

as result of electronic 

submission 

Burden Change 

803.19 3 1 Reduction (2 hours) 

803.30 and 809.32 1 0 .33 Reduction (.66 hours) 

803.33 1 1 no change 

803.40 and 803.42 1 0 .33 Reduction (.66 hours) 

803.50 and 803.52 1 0 .11 Reduction (.89 hours) 

803.56 1 0 .10 Reduction (.90 hours) 

As previously described, there are two 

reporting options. The first one is CeSub 

for low volume reporters and the second 

one is HL7 ICSR for high volume 

reporters. We are basing our hours per 

response for both systems on FDA’s 

experience using the two options. 

B. Recordkeeping Requirements 

The number of respondents for each 

CFR section in table 6 is based upon the 

number of respondents entered into 

FDA’s internal databases. The agency 

believes that the majority of 

manufacturers, user facilities, and 

importers have already established 

written procedures to document 

complaints and information to meet the 

MDR requirements as part of their 

internal quality control system. The 

following table summarizes our burden 

estimates and how we believe they will 

change due to electronic submission. 


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TABLE 8.—ESTIMATED RECORDKEEPING BURDEN PROGRAM CHANGE

21 CFR Section 

Hours per response 

under current paper 

submission process 

Hours per response 

as result of electronic 

submission 

Burden Change 

803.17 10 3 .3 Reduction (7.7 hours) 

803.18 (a) to (d) 1 .5 1 .5 No change 

C. Total Annual Cost Burden 

As stated earlier, the cost to 

respondents for these reporting and 

recordkeeping requirements is 

$1,000,913. In addition, the conversion 

from paper to electronic submissions 

will result in capital costs, both onetime costs as well as annual costs, as 

discussed earlier in this proposed rule 

in the economic analysis. One-time 

capital costs include the cost to modify 

reporting systems, installing and 

validating CeSub software, installing 

gateway to gateway submission 

capabilities, and acquiring e-certificates 

and have been estimated to range from 

a low of $58.6 million to a high of $79.7 

million. Once the procedures have been 

modified, there is an operating and 

maintenance cost to renew the digital 

certificate and maintain high-speed 

internet access, which have been 

estimated cost $8.5 million each year. 

Burden estimates are based on reports 

processed between July 1, 2005, and 

June 30, 2006, with the existing medical 

device adverse event reporting program. 

In compliance with the PRA, the 

agency has submitted the information 

collection provisions of this proposed 

rule to OMB for review. Interested 

persons are requested to send comments 

regarding information collection to 

OMB (see the DATES and ADDRESSES

sections of this document). 

VII. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that this rule does not 

contain policies that have federalism 

implications as defined in the order 

and, consequently, a federalism 

summary impact statement is not 

required. 

VIII. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IX. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. U.S. Census Bureau, 2002 Economic 

Census Industry Series: NAICS Code 62, 

Health Care and Social Assistance (http:// 

www.census.gov). Total is the sum of firms in 

NAICS 622, 6231, 6214, 6215, and 6216. 

2. BLS Occupational Employment and 

Wages May 2005 for Medical and Health 

Service Managers, Standard Occupational 

Classification, 11–19111. 

3. Pociask, Steven, A Survey of Small 

Businesses’ Telecommunications Use and 

Spending, SBA Office of Advocacy contract 

number SBA–HQ–02–M–0493, March 2004. 

List of Subjects in 21 CFR Part 803 

Imports, Medical devices, Reporting 

and recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, FDA proposes to 

amend part 803 to read as follows: 

PART 803—MEDICAL DEVICE 

REPORTING 

1. The authority citation for 21 CFR 

part 803 continues to read as follows: 

Authority: 21 U.S.C. 352, 360, 360i, 360j, 

371, 374. 

§ 803.3 [Amended] 

2. Amend § 803.3 by removing the 

definition for ‘‘Five-day report’’. 

§ 803.11 [Removed] 

3. Remove § 803.11. 

4. Revise § 803.12 to read as follows: 

§ 803.12 How do I submit reports and 

supplements? 

(a) Manufacturers, user facilities, and 

importers must submit initial and 

supplemental reports to FDA in an 

electronic format that FDA can process, 

review, and archive. FDA will provide 

and update information on how to 

provide the electronic submission (e.g., 

preparation and organization of files, 

file formats, media and method of 

transmission). 

(b) If you are confronted with a public 

health emergency, this can be brought to 

FDA’s attention by contacting the FDA 

Office of Emergency Operations (HFA– 

615), Office of Crisis Management, 

Office of the Commissioner, at 301–443– 

1240, followed by the submission of an 

e-mail to 

emergency.operations@fda.hhs.gov. 

Note: This action does not satisfy your 

obligation to report under part 803. 

(c) You may submit a voluntary 

telephone report to the MEDWATCH 

office at 800–FDA–1088. You may also 

obtain information regarding voluntary 

reporting from the MEDWATCH office 

at 800–FDA–1088. You may also find 

the voluntary MEDWATCH 3500 form 

and instructions to complete it at http:// 

www.fda.gov/Safety/MedWatch/ 

HowToReport/DownloadForms/ 

default.htm. 

5. Revise § 803.13 to read as follows: 

§ 803.13 Do I need to submit reports in 

English? 

Yes. You must submit all reports 

required by this part in English. 

§ 803.14 [Removed] 

6. Remove § 803.14. 

7. Amend § 803.18 by revising 

paragraph (b)(1)(ii) and adding 

paragraph (b)(1)(iii) to read as follows: 

§ 803.18 What are the requirements for 

establishing and maintaining MDR files or 

records that apply to me? 

* * * * * 

(b)(1) * * * 

(ii) Copies of all reports submitted 

under this part (whether paper or 

electronic), and of all other information 

related to the event that you submitted 

to us or other entities such as an 

importer, distributor, or manufacturer. 

(iii) Copies of all electronic 

acknowledgments FDA sends you in 

response to your electronic submissions. 

* * * * * 

8. Amend § 803.19 by revising 

paragraphs (b) and (e) to read as follows: 


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§ 803.19 Are there exemptions, variances, 

or alternative forms of adverse event 

reporting requirements? 

* * * * * 

(b) If you are a manufacturer, 

importer, or user facility, you may 

request an exemption or variance from 

any or all of the reporting requirements 

in this part, including the requirements 

of § 803.12(a). You must submit the 

request to us in writing at the following 

address: MDR Exemption Requests, 

Office of Surveillance and Biometrics 

(HFZ–530), 1350 Piccard Dr., Rockville, 

MD 20850. Your request must include 

information necessary to identify you 

and the device; a complete statement of 

the request for exemption, variance, or 

alternative reporting; and an 

explanation why your request is 

justified. If you are requesting a variance 

to the requirement to submit reports to 

FDA in electronic format, under 

§ 803.12(a), your request should indicate 

for how long you would require this 

variance. 

* * * * * 

(e) If we grant your request for a 

reporting modification, you must submit 

any reports or information required in 

our approval of the modification. The 

conditions of the approval will replace 

and supersede the regular reporting 

requirement specified in this part until 

such time that we revoke or modify the 

alternative reporting requirements in 

accordance with paragraph (d) of this 

section, or until the date specified in 

our response granting your variance, at 

which time, the provisions of this part 

will again apply. 

9. In § 803.20, revise paragraph (a), 

redesignate paragraphs (b) and (c) as 

paragraphs (c) and (d), and add new 

paragraph (b) to read as follows: 

§ 803.20 How do I complete and submit an 

individual adverse event report? 

(a) If you are a health professional or 

consumer, you may submit voluntary 

reports to FDA regarding devices or 

other FDA-regulated products using the 

FDA Form 3500. 

(b) A mandatory electronic 

submission from a user facility, 

importer, or manufacturer, must contain 

the information from the applicable 

blocks of FDA Form 3500A. All 

electronic submissions must include 

information about the patient, the event, 

the device, and the ‘‘initial reporter.’’ 

An electronic submission from a user 

facility or importer must include the 

information from block F. An electronic 

submission from a manufacturer must 

include the information from blocks G 

and H. If you are a manufacturer and 

you receive a report from a user facility 

or importer, you must incorporate that 

information in your electronic 

submission and include any corrected 

or missing information. 

* * * * * 

10. Add § 803.23 to read as follows: 

§ 803.23 Where can I find information on 

how to prepare and submit an MDR in 

electronic format? 

(a) You may obtain information on 

how to prepare and submit reports in an 

electronic format that FDA can process, 

review, and archive at http:// 

www.fda.gov/ForIndustry/FDA

eSubmitter/ucm107903.htm. 

(b) We may sometimes update 

information on how to prepare and 

submit reports electronically. If we do 

make modifications, we will ensure that 

we alert reporters by updating the eMDR 

Web page. 

11. Amend § 803.30 by revising 

paragraphs (a)(1) and (a)(2) to read as 

follows: 

§ 803.30 If I am a user facility, what 

reporting requirements apply to me? 

(a) * * * 

(1) Reports of death. You must submit 

a report to us as soon as practicable but 

no more than 10 work days after the day 

that you become aware of information, 

from any source, that reasonably 

suggests that a device has or may have 

caused or contributed to the death of a 

patient of your facility. You must also 

submit the report to the device 

manufacturer, if known. You must 

submit the information required by 

§ 803.32. Reports sent to the agency 

must be submitted in accordance with 

the requirements of § 803.12(a). 

(2) Reports of serious injury. You 

must submit a report to the 

manufacturer of the device no later than 

10 work days after the day that you 

become 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 your facility. If the 

manufacturer is not known, you must 

submit the report to us. You must report 

information required by § 803.32. 

Reports sent to the agency must be 

submitted in accordance with the 

requirements of § 803.12(a). 

* * * * * 

12. Amend § 803.32 by revising 

paragraphs (b)(4) and (c) to read as 

follows: 

§ 803.32 If I am a user facility, what 

information must I submit in my individual 

adverse event reports? 

* * * * * 

(b) * * * 

(4) Date of this report; 

* * * * * 

(c) Device information (Form 3500A, 

Block D). You must submit the 

following: 

(1) Brand name; 

(2) Product Code, if known, and 

Common Device Name; 

(3) Manufacturer name, city, and 

state; 

(4) Model number, catalog number, 

serial number, lot number, or other 

identifying number, and expiration date; 

(5) Operator of the device (health 

professional, lay user/ patient, other); 

(6) Date of device implantation 

(month, day, year), if applicable; 

(7) Date of device explantation 

(month, day, year), if applicable; 

(8) Whether the device is a single-use 

device that was reprocessed and reused 

on a patient (Yes, No)? 

(9) If the device is a single-use device 

that was reprocessed and reused on a 

patient (yes to paragraph (c)(8) of this 

section), the name and address of the 

reprocessor; 

(10) Whether the device was available 

for evaluation and whether the device 

was returned to the manufacturer; if so, 

the date it was returned to the 

manufacturer; and 

(11) Concomitant medical products 

and therapy dates. (Do not report 

products that were used to treat the 

event.) 

* * * * * 

13. Revise § 803.33 to read as follows: 

§ 803.33 If I am a user facility, what must 

I include when I submit an annual report? 

(a) You must submit to us an annual 

report on FDA Form 3419. You must 

submit an annual report by January 1, of 

each year. You may obtain this form 

from any of the following: 

(1) The Consolidated Forms and 

Publications Office, Beltsville Service 

Center, 6351 Ammendale Rd., Landover, 

MD 20705; 

(2) FDA, MEDWATCH (HF–2), 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–7240; 

(3) Division of Small Manufacturers, 

International, and Consumer Assistance, 

Office of Communication, Education, 

and Radiation Programs, Center for 

Devices and Radiological Health (CDRH) 

(HFZ–220), 1350 Piccard Dr., Rockville, 

MD 20850, by e-mail: 

DSMICA@CDRH.FDA.GOV, or FAX: 

301–443–8818; or 

(4) On the Internet at http:// 

www.fda.gov/Safety/MedWatch/How

ToReport/DownloadForms/default.htm. 

(b) You must clearly identify your 

annual report as such. You must submit 

your annual report to FDA, CDRH, 

Medical Device Reporting, P.O. Box 

3002, Rockville, MD 20847–3002. Your 

annual report must include: 


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(1) Your CMS provider number used 

for medical device reports, or the 

number assigned by us for reporting 

purposes in accordance with § 803.3; 

(2) Reporting year; 

(3) Your name and complete address; 

(4) Total number of reports attached 

or summarized; 

(5) Date of the annual report and 

report numbers identifying the range of 

medical device reports that you 

submitted during the report period (e.g., 

1234567890–2007–0001 through 1000); 

(6) Name, position title, and complete 

address of the individual designated as 

your contact person responsible for 

reporting to us and whether that person 

is a new contact for you; and 

(7) Information for each reportable 

event that occurred during the annual 

reporting period including: 

(i) 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 us; 

and 

(vi) Where the report was submitted, 

i.e., to the manufacturer, importer, or us. 

(c) In lieu of submitting the 

information in paragraph (b)(7) of this 

section, you may submit a copy of each 

medical device report that you 

submitted to the manufacturers and/or 

to us during the reporting period. 

(d) If you did not submit any medical 

device reports to manufacturers or us 

during the time period, you do not need 

to submit an annual report. 

14. Revise § 803.40 to read as follows: 

§ 803.40 If I am an importer, what reporting 

requirements apply to me? 

(a) Reports of deaths or serious 

injuries. You must submit a report to us, 

and a copy of this report to the 

manufacturer, as soon as practicable, 

but no later than 30 calendar days after 

the day that you receive or otherwise 

become aware of information from any 

source, including user facilities, 

individuals, or medical or scientific 

literature, whether published or 

unpublished, that reasonably suggests 

that one of your marketed devices may 

have caused or contributed to a death or 

serious injury. You must submit the 

information required by § 803.42. 

Reports must be submitted in 

accordance with the requirements of 

§ 803.12(a). 

(b) Reports of malfunctions. You must 

submit a report to the manufacturer as 

soon as practicable but no later than 30 

calendar days after the day that you 

receive or otherwise become aware of 

information from any source, including 

user facilities, individuals, or through 

your own research, testing, evaluation, 

servicing, or maintenance of one of your 

devices, that reasonably suggests that 

one of your devices has malfunctioned 

and that this device or a similar device 

that you market would be likely to cause 

or contribute to a death or serious injury 

if the malfunction were to recur. You 

must submit the information required 

by § 803.42. 

15. Amend § 803.42 by revising 

paragraphs (b)(4) and (c) to read as 

follows: 

§ 803.42 If I am an importer, what 

information must I submit in my individual 

adverse event reports? 

* * * * * 

(b) * * * 

(4) Date of this report; 

* * * * * 

(c) Device information (Form 3500A, 

Block D). You must submit the 

following: 

(1) Brand name; 

(2) Product Code, if known, and 

Common Device Name; 

(3) Manufacturer name, city, and 

state; 

(4) Model number, catalog number, 

serial number, lot number, or other 

identifying number, and expiration date; 

(5) Operator of the device (health 

professional, lay user/patient, other); 

(6) Date of device implantation 

(month, day, year), if applicable; 

(7) Date of device explantation 

(month, day, year), if applicable; 

(8) Whether the device is a single-use 

device that was reprocessed and reused 

on a patient (Yes, No)? 

(9) If the device is a single-use device 

that was reprocessed and reused on a 

patient (yes to paragraph (c)(8) of this 

section), the name and address of the 

reprocessor; 

(10) Whether the device was available 

for evaluation and whether the device 

was returned to the manufacturer; if so, 

the date it was returned to the 

manufacturer; and 

(11) Concomitant medical products 

and therapy dates. (Do not report 

products that were used to treat the 

event.) 

* * * * * 

16. Amend § 803.50 by revising 

paragraph (a) introductory text and 

paragraph (b)(3) to read as follows: 

§ 803.50 If I am a manufacturer, what 

reporting requirements apply to me? 

(a) If you are a manufacturer, you 

must report to us the information 

required by § 803.52 in accordance with 

the requirements of § 803.12(a), no later 

than 30 calendar days after the day that 

you receive or otherwise become aware 

of information, from any source, that 

reasonably suggests that a device that 

you market: 

* * * * * 

(b) * * * 

(3) You are also responsible for 

conducting an investigation of each 

event and evaluating the cause of the 

event. If you cannot submit complete 

information on a report, you must 

provide a statement explaining why this 

information was incomplete and the 

steps you took to obtain the information. 

If you later obtain any required 

information that was not available at the 

time you filed your initial report, you 

must submit this information in a 

supplemental report under § 803.56 in 

accordance with the requirements of 

§ 803.12(a). 

17. Amend § 803.52 by revising 

paragraphs (b)(4), (c), and (e) to read as 

follows: 

§ 803.52 If I am a manufacturer, what 

information must I submit in my individual 

adverse event reports? 

* * * * * 

(b) * * * 

(4) Date of this report; 

* * * * * 

(c) Device information (Form 3500A, 

Block D). You must submit the 

following: 

(1) Brand name; 

(2) Product code, if known, and 

Common Device Name; 

(3) Manufacturer name, city, and 

state; 

(4) Model number, catalog number, 

serial number, lot number, or other 

identifying number, and expiration date; 

(5) Operator of the device (health 

professional, lay user/patient, other); 

(6) Date of device implantation 

(month, day, year), if applicable; 

(7) Date of device explantation 

(month, day, year), if applicable; 

(8) Whether the device is a single-use 

device that was reprocessed and reused 

on a patient (Yes, No)? 

(9) If the device is a single-use device 

that was reprocessed and reused on a 

patient (yes to paragraph (c)(8) of this 

section), the name and address of the 

reprocessor; 

(10) Whether the device was available 

for evaluation and whether the device 

was returned to the manufacturer; if so, 

the date it was returned to the 

manufacturer; and 

(11) Concomitant medical products 

and therapy dates. (Do not report 

products that were used to treat the 

event.) 

* * * * * 


CPrice-Sewell on DSKGBLS3C1PROD with PROPOSALS
Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Proposed Rules 42217 

(e) Reporting information for all 

manufacturers (Form 3500A, Block G). 

You must submit the following: 

(1) Your reporting office’s contact 

name and address and device 

manufacturing site; 

(2) The contact’s telephone number; 

(3) Your report sources; 

(4) Date received by you (month, day, 

year); 

(5) PMA/510k Number and whether 

or not the product is a combination 

product; 

(6) Type of report being submitted 

(e.g., 5–day, initial, followup); and 

(7) Your report number. 

* * * * * 

18. Revise the introductory text of 

§ 803.53 to read as follows: 

§ 803.53 If I am a manufacturer, in which 

circumstances must I submit a 5-day 

report? 

You must submit a 5-day report to us 

with the information required by 

§ 803.52 in accordance with the 

requirements of § 803.12(a) no later than 

5 work days after the day that you 

become aware that: 

* * * * * 

19. Amend § 803.56 by revising the 

introductory text and paragraphs (a) and 

(c) to read as follows: 

§ 803.56 If I am a manufacturer, in what 

circumstances must I submit a 

supplemental or followup report and what 

are the requirements for such reports? 

If you are a manufacturer, when you 

obtain information required under this 

part that you did not provide because it 

was not known or was not available 

when you submitted the initial report, 

you must submit the supplemental 

information to us within 30 calendar 

days of the day that you receive this 

information. You must submit the 

supplemental or followup report in 

accordance with the requirements of 

§ 803.12(a). On a supplemental or 

followup report, you must: 

(a) Indicate that the report being 

submitted is a supplemental or followup 

report; 

* * * * * 

(c) Include only the new, changed, or 

corrected information. 

Dated: August 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19683 Filed 8–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–331] 

Schedules of Controlled Substances: 

Placement of 5-Methoxy-N,NDimethyltryptamine Into Schedule I of 

the Controlled Substances Act 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Notice of Proposed Rulemaking. 

SUMMARY: The Deputy Administrator of 

the Drug Enforcement Administration 

(DEA) is issuing this notice of proposed 

rulemaking to place the substance 5- 

methoxy-N,N-dimethyltryptamine (5- 

MeO-DMT) and its salts into schedule I 

of the Controlled Substances Act (CSA). 

This proposed action is based on a 

recommendation from the Acting 

Assistant Secretary for Health of the 

Department of Health and Human 

Services (DHHS) and on an evaluation 

of the relevant data by DEA. If finalized 

as proposed, this action would impose 

the criminal sanctions and regulatory 

controls of schedule I substances under 

the CSA on the manufacture, 

distribution, dispensing, importation, 

exportation, and possession of 5-MeODMT. 

DATES: Written comments must be 

postmarked, and electronic comments 

must be sent, on or before September 21, 

2009. Commenters should be aware that 

the electronic Federal Docket 

Management System will not accept 

comments after midnight Eastern time 

on the last day of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–331’’ on all written and 

electronic correspondence. Written 

comments being sent via regular or 

express mail should be sent to the Drug 

Enforcement Administration, Attention: 

DEA Federal Register Representative/ 

ODL, 8701 Morrissette Drive, 

Springfield, VA 22152. Comments may 

be sent to DEA by sending an electronic 

message to 

dea.diversion.policy@usdoj.gov. 

Comments may also be sent 

electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the 

http://www.regulations.gov Web site. 

DEA will accept electronic comments 

containing Microsoft Word, 

WordPerfect, Adobe PDF, or Excel files 

only. DEA will not accept any file 

format other than those specifically 

listed here. 

Please note that DEA is requesting 

that electronic comments be submitted 

before midnight Eastern time on the day 

the comment period closes because 

http://www.regulations.gov terminates 

the public’s ability to submit comments 

at midnight Eastern time on the day the 

comment period closes. Commenters in 

time zones other than Eastern time may 

want to consider this so that their 

electronic comments are received. All 

comments sent via regular or express 

mail will be considered timely if 

postmarked on the day the comment 

period closes. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, Ph.D., Chief, 

Drug and Chemical Evaluation Section, 

Office of Diversion Control, Drug 

Enforcement Administration, 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone: (202) 307–7183. 

SUPPLEMENTARY INFORMATION: 

Comments and Requests for Hearing 

In accordance with the provisions of 

the CSA (21 U.S.C. 811(a)), this action 

is a formal rulemaking ‘‘on the record 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of the Administrative 

Procedure Act (5 U.S.C. 556 and 557). 

All persons are invited to submit their 

comments or objections with regard to 

this proposal. Requests for a hearing 

may be submitted by interested persons 

and must conform to the requirements 

of 21 CFR 1308.44 and 1316.47. The 

request should state, with particularity, 

the issues concerning which the person 

desires to be heard and the requestor’s 

interest in the proceeding. Only 

interested persons, defined in the 

regulations as those ‘‘adversely affected 

or aggrieved by any rule or proposed 

rule issuable pursuant to section 201 of 

the Act (21 U.S.C. 811),’’ may request a 

hearing. 

21 CFR 1308.42. Please note that DEA 

may grant a hearing only ‘‘for the 

purpose of receiving factual evidence 

and expert opinion regarding the issues 

involved in the issuance, amendment or 

repeal of a rule issuable’’ pursuant to 21 

U.S.C. 811(a). All correspondence 

regarding this matter should be 

submitted to the DEA using the address 

information provided above. 

Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record and made available for 

public inspection online at http:// 

www.regulations.gov and in the Drug 


CPrice-Sewell on DSKGBLS3C1PROD with PROPOSALS