Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40973 

Garrison, ND, Garrison Muni, RNAV (GPS) 

RWY 13, Amdt 2 

Garrison, ND, Garrison Muni, RNAV (GPS) 

RWY 31, Amdt 2 

Manchester, NH, Manchester, Takeoff 

Minimums and Obstacle DP, Amdt 10B 

Mesquite, NV, Mesquite, RNAV (GPS) Y 

RWY 2, Orig 

Mesquite, NV, Mesquite, RNAV (GPS) Z 

RWY 2, Orig 

Mesquite, NV, Mesquite, Takeoff Minimums 

and Obstacle DP, Orig 

Minden, NV, Minden-Tahoe, RNAV (GPS)-A, 

Amdt 1 

Minden, NV, Minden-Tahoe, RNAV (GPS)-B, 

Amdt 1 

Columbus, OH, Bolton Field, ILS OR LOC 

RWY 4, Amdt 5A 

Columbus, OH, Bolton Field, NDB RWY 4, 

Amdt 7A 

Columbus, OH, Bolton Field, RNAV (GPS) 

RWY 4, Orig-B 

Lebanon, OH, Warren County/John Lane 

Field, NDB–A, Amdt 6 

Idabel, OK, Mc Curtain County Rgnl, RNAV 

(GPS) RWY 2, Amdt 1 

Idabel, OK, Mc Curtain County Rgnl, RNAV 

(GPS) RWY 20, Amdt 1 

Corvallis, OR, Corvallis Muni, ILS OR LOC 

RWY 17, Amdt 5 

Corvallis, OR, Corvallis Muni, RNAV (GPS) 

RWY 35, Amdt 3 

Corvallis, OR, Corvallis Muni, VOR RWY 17, 

Amdt 8 

Corvallis, OR, Corvallis Muni, VOR RWY 35, 

Amdt 12 

Corvallis, OR, Corvallis Muni, VOR–A, Amdt 

11 

Borger, TX, Hutchinson County, RNAV (GPS) 

RWY 17, Amdt 1 

Borger, TX, Hutchinson County, RNAV (GPS) 

RWY 35, Amdt 1 

Dallas, TX, Dallas Love Field, ILS OR LOC 

RWY 31L, Amdt 22A 

Dallas, TX, Dallas Love Field, ILS OR LOC 

RWY 31R, ILS RWY 31R SA CAT I, ILS 

RWY 31R SA CAT II, Amdt 7 

Dallas, TX, Dallas Love Field, ILS Y OR LOC 

Y RWY 13L, Amdt 33A 

Dallas, TX, Dallas Love Field, ILS Y OR LOC 

Y RWY 13R, Amdt 6A 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Y RWY 13L, Amdt 1C 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Y RWY 13R, Orig-B 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Y RWY 31L, Amdt 1E 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Y RWY 31R, Amdt 3 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Z RWY 13L, Amdt 3B 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Z RWY 13R, Amdt 2A 

Dallas, TX, Dallas Love Field, RNAV (RNP) 

W RWY 13L, Orig-C 

Dallas, TX, Dallas Love Field, RNAV (RNP) 

X RWY 13L, Orig-C 

Houston, TX, West Houston, RNAV (GPS) 

RWY 15, Amdt 1C 

Houston, TX, West Houston, RNAV (GPS) 

RWY 33, Amdt 1B 

Houston, TX, West Houston, VOR–D, Amdt 

1, CANCELED 

La Grange, TX, Fayette Rgnl Air Center, 

Takeoff Minimums and Obstacle DP, 

Amdt 1 

Port Lavaca, TX, Calhoun County, Takeoff 

Minimums and Obstacle DP, Orig-A 

RESCINDED: On July 16, 2018 (83 FR 

32766), the FAA published an Amendment 

in Docket No. 31202, Amdt No. 3807, to Part 

97 of the Federal Aviation Regulations under 

section 97.25, 97.29, 97.33, and 97.37. The 

following entries for Asheville, NC, and 

Cleveland, TN, effective September 13, 2018, 

are hereby rescinded in their entirety: 

Asheville, NC, Asheville Rgnl, ILS OR LOC 

RWY 35, Orig 

Asheville, NC, Asheville Rgnl, ILS OR LOC 

RWY 35, Orig, CANCELED 

Asheville, NC, Asheville Rgnl, LOC RWY 17, 

Orig 

Asheville, NC, Asheville Rgnl, RNAV (GPS) 

RWY 17, Orig 

Asheville, NC, Asheville Rgnl, RNAV (GPS) 

RWY 17, Orig, CANCELED 

Asheville, NC, Asheville Rgnl, RNAV (GPS) 

RWY 35, Orig 

Asheville, NC, Asheville Rgnl, RNAV (GPS) 

RWY 35, Orig, CANCELED 

Asheville, NC, Asheville Rgnl, Takeoff 

Minimums and Obstacle DP, Amdt 1 

Cleveland, TN, Cleveland Rgnl Jetport, RNAV 

(GPS) RWY 3, Amdt 2 

Cleveland, TN, Cleveland Rgnl Jetport, RNAV 

(GPS) RWY 21, Amdt 2 

Cleveland, TN, Cleveland Rgnl Jetport, 

Takeoff Minimums and Obstacle DP, 

Amdt 2 

[FR Doc. 2018–17619 Filed 8–16–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 803 

[Docket No. FDA–2017–N–6730] 

Medical Devices and Device-Led 

Combination Products; Voluntary 

Malfunction Summary Reporting 

Program for Manufacturers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification; order granting 

alternative. 

SUMMARY: The Food and Drug 

Administration’s (FDA, Agency, or we) 

Center for Devices and Radiological 

Health and Center for Biologics 

Evaluation and Research are 

announcing that the Agency is granting 

an alternative that permits manufacturer 

reporting of certain device malfunction 

medical device reports (MDRs) in 

summary form on a quarterly basis. We 

refer to this alternative as the 

‘‘Voluntary Malfunction Summary 

Reporting Program.’’ This voluntary 

program reflects goals for streamlining 

malfunction reporting outlined in the 

commitment letter agreed to by FDA 

and industry and submitted to Congress, 

as referenced in the Medical Device 

User Fee Amendments of 2017 (MDUFA 

IV Commitment Letter). 

DATES: This voluntary program applies 

only to reportable malfunction events 

that manufacturers become aware of on 

or after August 17, 2018. See further 

discussion in section IV.F. ‘‘Submission 

Schedule and Logistics.’’ 

FOR FURTHER INFORMATION CONTACT: 

Michelle Rios, Center for Devices and 

Radiological Health (CDRH), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 3222, 

Silver Spring, MD 20993, 301–796– 

6107, MDRPolicy@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911; or CBER, Office of 

Communication, Outreach, and 

Development (OCOD), 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002; or by 

calling 1–800–835–4709 or 240–402– 

8010; or email: ocod@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Every year, FDA receives hundreds of 

thousands of MDRs of suspected deviceassociated deaths, serious injuries, and 

malfunctions. The Agency’s MDR 

program is one of the postmarket 

surveillance tools FDA uses to monitor 

device performance, detect potential 

device-related safety issues, and 

contribute to benefit-risk assessments. 

Malfunction reports represent a 

substantial fraction of the MDRs FDA 

receives on an annual basis. 

Medical device reporting 

requirements for manufacturers are set 

forth in section 519 of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360i) and the regulations 

contained in part 803 (21 CFR part 803). 

Among other things, part 803 requires 

the submission of an individual MDR 

when a manufacturer becomes aware of 

information, from any source, which 

reasonably suggests that one of its 

marketed devices malfunctioned and 

the malfunction of the device or a 

similar device marketed by the 

manufacturer would be likely to cause 

or contribute to a death or serious injury 

if the malfunction were to recur 

(§§ 803.10(c)(1) and 803.50(a)(2). 

Throughout this document, we refer to 

such malfunctions as ‘‘reportable 

malfunctions’’ or ‘‘reportable 

malfunction events.’’ 

The Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 


daltland on DSKBBV9HB2PROD with RULES
40974 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 

(Pub. L. 110–85) amended section 519(a) 

of the FD&C Act related to the reporting 

of device malfunctions. FDAAA did not 

alter the malfunction reporting 

requirements for class III devices and 

those class II devices that are 

permanently implantable, life 

supporting, or life sustaining. Under 

section 519(a)(1)(B)(i) of the FD&C Act, 

as amended by FDAAA, manufacturers 

of those devices must continue to 

submit malfunction reports in 

accordance with part 803 (or successor 

regulations), unless FDA grants an 

exemption or variance from, or an 

alternative to, a requirement under such 

regulations under § 803.19. However, 

FDAAA amended the FD&C Act to 

require that malfunction MDRs for class 

I and those class II devices that are not 

permanently implantable, life 

supporting, or life sustaining—other 

than any type of class I or II device that 

FDA has, by notice, published in the 

Federal Register or by letter to the 

person who is the manufacturer or 

importer of the device, indicated should 

be subject to part 803 in order to protect 

the public health—be submitted in 

accordance with the criteria established 

by FDA. The criteria require the 

malfunction reports to be in summary 

form and made on a quarterly basis 

(section 519(a)(1)(B)(ii) of the FD&C 

Act). In the Federal Register of March 

8, 2011 (76 FR 12743), FDA explained 

that, pending further notice from the 

Agency, all class I devices and those 

class II devices that are not permanently 

implantable, life supporting, or life 

sustaining would remain subject to 

individual reporting requirements under 

part 803 to protect the public health, 

pursuant to section 519(a)(1)(B)(i)(III) of 

the FD&C Act. Consequently, unless 

granted an exemption, variance, or 

alternative, manufacturers of those 

devices have continued to be required to 

submit individual malfunction reports 

under part 803. Under § 803.19, FDA 

may grant exemptions or variances 

from, or alternatives to, any or all of the 

reporting requirements in part 803, and 

may change the frequency of reporting 

to quarterly, semiannually, annually, or 

other appropriate time period. FDA may 

grant such modifications upon request 

or at its discretion, and when granting 

such modifications, FDA may impose 

other reporting requirements to ensure 

the protection of the public health. (See 

§ 803.19(c)) 

In the Federal Register of December 

26, 2017 (82 FR 60922), FDA issued a 

notification outlining FDA’s proposal to 

grant an alternative under § 803.19 to 

permit manufacturer reporting of certain 

device malfunctions in summary form 

on a quarterly basis, subject to certain 

conditions, and requested comments 

(2017 Proposal). As explained in the 

2017 Proposal, the Voluntary 

Malfunction Summary Reporting 

Program is intended to reflect goals for 

streamlining malfunction reporting that 

FDA and industry agreed to in the 

MDUFA IV Commitment Letter (Ref. 1). 

The 2017 Proposal also summarized 

FDA’s previous experience with 

summary reporting programs, key 

findings from an FDA pilot program for 

the submission of MDRs in summary 

format on a quarterly basis (see 80 FR 

50010, August 18, 2015), additional 

background regarding the development 

of the proposal, and the anticipated 

benefits of summary reporting under the 

proposal. Interested persons were given 

the opportunity to submit comments by 

February 26, 2018. 

II. Comments on the Proposed 

Alternative and FDA’s Response 

In response to the 2017 Proposal, FDA 

received 24 comments from industry, 

professional societies, trade 

organizations, and individual 

consumers by the close of the comment 

period, each containing one or more 

comments on one or more issues. A 

summary of the comments to the docket 

and our responses follow. To make it 

easier to identify comments and our 

responses, the word ‘‘Comment’’ 

appears in parentheses before the 

comment’s description, and the word 

‘‘Response’’ in parentheses precedes the 

response. The comments are grouped 

based on common themes and 

numbered sequentially. 

A. General Comments 

(Comment 1) Three comments 

suggested that the proposal was 

inconsistent with amendments made by 

section 227 of FDAAA to section 519(a) 

of the FD&C Act regarding malfunction 

reporting requirements. Two of these 

comments specifically recommended 

that FDA immediately implement 

summary, quarterly malfunction 

reporting under section 519(a)(1)(B)(ii) 

of the FD&C Act for all class I devices 

and those class II devices that are not 

permanently implantable, life 

supporting, or life sustaining. 

(Response 1) FDA disagrees with 

these comments. As discussed in the 

2017 Proposal, currently, there are still 

reportable malfunctions for which 

submission of individual malfunction 

reports on a prompter basis than 

quarterly is necessary to protect the 

public health—for example, when 

remedial action is needed to prevent an 

unreasonable risk of substantial harm to 

the public health. Those situations may 

involve class I devices and class II 

devices that are not permanently 

implantable, life supporting, or life 

sustaining, and it is not feasible for FDA 

to provide notice in the Federal Register 

or by letter to individual manufacturers, 

pursuant to section 519(a)(1)(B)(i)(III) of 

the FD&C Act, each time one of these 

situations arises. For example, FDA may 

not become aware of the situation until 

it receives an MDR from a manufacturer. 

Therefore, in accordance with section 

519(a)(1)(B)(i)(III) of the FD&C Act, 

manufacturers of class I devices and 

those class II devices that are not 

permanently implantable, life 

supporting, or life sustaining remain 

subject to individual reporting 

requirements in part 803, unless granted 

an exemption, variance, or alternative, 

to protect the public health. However, 

FDA does believe that malfunction 

summary reporting on a quarterly basis, 

in accordance with the conditions 

described in section IV, will reduce 

burden on FDA and manufacturers and 

allow FDA to effectively monitor many 

devices. Accordingly, the Agency is 

granting an alternative under section 

519(a)(1)(B)(i) of the FD&C Act and 

§ 803.19 to permit manufacturers of 

those devices to submit summary, 

quarterly malfunction reports, with 

certain conditions. 

(Comment 2) Several comments raised 

concerns that the proposed program 

would be unable to provide FDA with 

critical information on adverse event 

reporting. Many of the comments from 

individual consumers also raised 

concerns that the proposed program 

would limit transparency of 

malfunction event data that is publicly 

available to patients and physicians, 

including transparency regarding the 

number of reported malfunctions. 

However, another comment indicated 

that the proposed program would 

minimize burden while maintaining 

patient safety. That same comment 

further indicated that the proposed 

malfunction summary reporting format 

would enhance public visibility into the 

events and associated investigation 

compared to a format previously used 

for the Alternative Summary Reporting 

(ASR) program. 

(Response 2) FDA disagrees with the 

comments suggesting that the Voluntary 

Malfunction Summary Reporting 

Program will negatively affect patient 

safety and the transparency of 

malfunction reports. Summary, 

quarterly reporting in accordance with 

this program will result in some 

malfunction reports being submitted to 

FDA and added to the publicly available 

Manufacturer and User Facility Device 

Experience (MAUDE) database later 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40975 

than this occurs under FDA’s current 

individual reporting requirements. 

However, as explained in our 2017 

Proposal, we believe this reporting 

format and schedule will also yield 

benefits for FDA and the public, such as 

helping FDA process malfunction 

reports more efficiently and helping 

both FDA and the public more readily 

identify malfunction trends. 

While summary malfunction reports 

submitted under this program will 

change the format in which information 

is presented to FDA, we do not believe 

there will be an adverse impact on the 

content of information provided to FDA. 

The format for summary reporting 

described in section IV.D includes a 

narrative section for describing 

malfunctions, similar to the narrative 

section required for individual 

reporting. In addition, each narrative 

section is required to include a sentence 

specifying the number of malfunction 

events summarized in the report, 

providing transparency for the public 

regarding the number of events that a 

summary report available in MAUDE 

represents. Therefore, we agree with the 

comment that the summary reporting 

format will improve transparency for 

the public when compared to some past 

summary reports submitted to FDA, 

such as reports submitted under the 

ASR program (Ref. 2). 

(Comment 3) One comment requested 

clarification as to whether a 

manufacturer would need to apply or 

obtain permission to participate in the 

program and asked FDA to clarify how 

the proposed program would work with 

other alternative summary reporting 

situations. Another comment asked FDA 

to clarify whether manufacturers can 

still apply for an exemption or variance 

to be granted under § 803.19 for their 

devices that do not fall under an eligible 

product code. 

(Response 3) FDA is clarifying in the 

description of the alternative that 

manufacturers do not need to submit a 

request or application to FDA before 

participating in the Voluntary 

Malfunction Summary Reporting 

Program. For devices that fall within 

eligible product codes, the alternative 

that FDA is granting under § 803.19 

provides that manufacturers may choose 

or ‘‘self-elect’’ to participate, subject to 

the program conditions identified in 

section IV. If a manufacturer wishes to 

request a different exemption, variance, 

or alternative under § 803.19 (including 

for devices in product codes that are 

eligible for the Voluntary Malfunction 

Summary Reporting Program) the 

manufacturer may submit a request to 

FDA. For more information regarding 

the recommended content of such 

requests, see section 2.27 of the 

Agency’s guidance entitled ‘‘Medical 

Device Reporting for Manufacturers: 

Guidance for Industry and Food and 

Drug Administration Staff’’ (MDR 

Guidance) (Ref. 3). 

Whether participation in the 

Voluntary Malfunction Summary 

Reporting Program will have an impact 

on a manufacturer being granted a 

different exemption, variance, or 

alternative under § 803.19 will depend 

on the scope of the other exemption, 

variance, or alternative. FDA will make 

a case-by-case determination on 

requests for an exemption, variance, or 

alternative submitted under § 803.19(b). 

B. Scope of Program 

(Comment 4) Several comments also 

discussed the scope of product codes 

that should be eligible for the proposed 

program. One comment expressed 

concern about including class III 

devices and class II devices that are 

permanently implantable, lifesupporting, or life-sustaining in the 

program and urged FDA to issue another 

Federal Register notice with the list of 

eligible product codes for these 

categories of devices for public 

comment before allowing summary, 

quarterly malfunction reporting for 

those devices. In contrast, another 

comment asserted that all devices 

should be eligible for malfunction 

summary reporting, unless there is an 

express determination, subject to public 

input, that permitting summary 

reporting for a device would present 

public health concerns. Other comments 

recommended that all device product 

codes should be eligible for summary, 

quarterly malfunction reporting, with 

the exception of product codes for class 

III devices and class II devices that are 

permanently implantable, life 

supporting, or life sustaining when 

those product codes have been in 

existence for less than 2 years. 

(Response 4) FDA disagrees that it 

should publish another Federal Register 

notice for public comment listing 

product codes that would be eligible or 

ineligible for the program. Among other 

reasons, the Agency expressly requested 

comment on the product codes that 

should be eligible for the proposed 

program, and many commenters 

submitted proposed lists of eligible 

product codes or identified specific 

devices about which they had concerns. 

FDA has considered these comments 

and has also conducted an extensive 

review of all product codes, regardless 

of device class, to determine whether 

each product code would be eligible. In 

addition, consistent with its 2017 

Proposal, product codes that have been 

in existence for less than 2 years are not 

included in the list of eligible product 

codes, unless the new product code was 

created solely for administrative 

reasons. In FDA’s experience, this 2- 

year period is an important period for 

having more timely, detailed 

information to monitor malfunction 

events. That 2-year timeframe for new 

product codes is also consistent with 

the MDUFA IV Commitment Letter (Ref. 

1). 

(Comment 5) Three comments 

recommended that importers be 

included within the scope of the 

proposed program and indicated that 

FDA should provide a rationale for not 

including them. One of those comments 

suggested that without more 

information, it appeared arbitrary that 

FDA did not include importers and user 

facilities in the summary reporting 

program. 

(Response 5) FDA disagrees with 

these comments. Unlike manufacturers, 

device user facilities are not required to 

submit malfunction reports under part 

803. User facilities, such as hospitals or 

nursing homes, are required to submit 

MDRs to FDA and/or the manufacturer 

only for reportable death or serious 

injury events. (See section 519(b) of the 

FD&C Act; § 803.30(a)). 

Importers are also subject to different 

requirements for reporting device 

malfunctions than those for 

manufacturers under part 803. Under 

§ 803.40, importers are required to 

submit a report to the device 

manufacturer, not to FDA, within 30 

days after becoming aware of a 

reportable malfunction event. 

Manufacturers then determine the 

reportability of the information received 

from the importer and accordingly 

submit those reports to FDA. This 

program specifically addresses 

malfunction summary reporting to FDA. 

In addition, we believe it is important 

for importers to continue to submit 

individual malfunction MDRs to device 

manufacturers in accordance with 

§ 803.40 so that manufacturers receive 

detailed information necessary to 

conduct adequate investigations and 

follow up related to malfunction events. 

C. Individual Reporting Conditions 

(Comment 6) One comment suggested 

that when requesting that a 

manufacturer submit a 5-day report, 

FDA should have an objective and 

documented basis for making such a 

request, as well as an opportunity for 

manufacturers to appeal. Other 

comments asked FDA to define the term 

‘‘substantially similar’’ as used in 

describing the program condition 

regarding 5-day reports and to clarify 


daltland on DSKBBV9HB2PROD with RULES
40976 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 

what constitutes an ‘‘imminent hazard’’ 

and whether this is analogous to 

reportable malfunctions requiring a 5- 

day report. 

(Response 6) The circumstances in 

which a 5-day report is required are 

defined under § 803.53, and those 

circumstances remain unchanged for 

manufacturers participating in the 

Voluntary Malfunction Summary 

Reporting Program. As stated in the 

2017 Proposal, the reporting 

requirements at § 803.53 will continue 

to apply to manufacturers of devices in 

eligible product codes who participate 

in this program. We have added a 

separate heading to the description of 

the alternative to clarify this point 

further. For more information regarding 

the handling of a 5-day report, please 

see section 2.20 of the Agency’s MDR 

Guidance (Ref. 3). 

The first individual reporting 

condition requires that if a manufacturer 

submits a 5-day report for an event or 

events that require remedial action to 

prevent an unreasonable risk of 

substantial harm to public health, all 

subsequent reportable malfunctions of 

the same nature that involve 

substantially similar devices must be 

submitted as individual MDRs in 

accordance with §§ 803.50 and 803.52 

until the date that the remedial action 

has been resolved to FDA’s satisfaction. 

For purposes of this individual 

reporting condition, a ‘‘substantially 

similar’’ device could be, for example, a 

device that is the same except for 

certain performance characteristics or a 

device that is the same except for 

certain cosmetic differences in color or 

shape. 

Regarding the term ‘‘imminent 

hazard,’’ FDA notes that the term is 

used to describe one of the general 

overarching principles for summary 

reporting, but is not included in the 

descriptions of any of the individual 

reporting conditions. For purposes of 

these overarching principles, we intend 

‘‘imminent hazard’’ to capture situations 

in which a device poses a significant 

risk to health and creates a public health 

situation that should be addressed 

immediately to prevent injury. Use of 

that term in one of the overarching 

principles was not intended to indicate 

any change in the standard for a 5-day 

report under § 803.53. 

(Comment 7) One comment indicated 

that there should be objective and 

documented criteria for when FDA 

would provide written notice that 

manufacturers must submit an 

individual, 30-day malfunction report in 

accordance with the proposed program 

conditions, along with an opportunity 

for appeal. The comment further 

asserted that due process considerations 

need to be made regarding these 

reporting requirements, including 

notice, a written justification for the 

request, and a process to appeal. 

(Response 7) FDA disagrees that there 

should be fixed criteria for notifying a 

manufacturer that it must submit an 

individual, 30-day malfunction report in 

accordance with the program 

conditions. Manufacturers who are 

notified to submit individual reports in 

accordance with the individual 

reporting conditions will need to 

comply with MDR requirements to 

which they would otherwise be subject 

if not granted this alternative under 

§ 803.19. FDA has provided examples of 

when it would make these notifications, 

but public health issues that require 

submission of individual MDRs to 

monitor device safety are not uniform 

and may arise in various ways. 

FDA will provide written notice to 

manufacturers when they need to 

submit individual MDRs pursuant to 

individual reporting conditions 3 and 4, 

as described in section IV.B. In addition, 

the Agency already has a process in 

place for stakeholders to request review 

of decisions made by CDRH employees. 

For more information, refer to the FDA 

Guidance entitled ‘‘Center for Devices 

and Radiological Health Appeals 

Processes’’ (Ref. 4). 

(Comment 8) Some comments 

disagreed with the proposed program 

condition that would have required 

manufacturers to submit individual, 30- 

day MDRs for reportable malfunction 

events that are the subject of any 

ongoing device recall and suggested that 

the condition be modified or removed. 

The comments cited several different 

reasons for objecting to this condition, 

including that the condition is not 

mentioned in the MDUFA IV 

Commitment Letter, that the condition 

may discourage manufacturers from 

conducting voluntary or class III recalls, 

that the condition is duplicative of 

information that FDA receives during a 

recall, and that it may be difficult for 

manufacturers to manage the 

requirements (e.g., new events may be 

uncovered during a product 

investigation leading to confusion and 

multiple reports for the same incident). 

Suggestions from the commenters 

regarding this individual reporting 

condition included the following: (a) 

The condition should only apply to 

mandatory or FDA-initiated recalls, and 

summary reporting should be permitted 

for voluntary or low-risk class III recalls 

and for incidents related to remedial 

action after the first (parent) MDR is 

submitted, unless a death or serious 

injury is associated; (b) FDA should 

clarify how to handle malfunction 

events that were not submitted as 

individual MDRs, but subsequently, 

prior to the next summary reporting 

date, are identified to be the result of an 

issue addressed by a recall; (c) the 

timeframe for submitting individual 

MDRs should be changed from 90 days 

past the date of the termination of the 

recall to 90 days past the date of the 

recall; and (d) FDA should clarify what 

it means by ‘‘malfunction events of the 

same nature.’’ 

(Response 8) FDA disagrees with the 

comments recommending removal of 

this individual reporting condition. 

Recall classification takes into account 

both the severity of harm and the 

likelihood of occurrence, and it is 

important for FDA to have access to 

more timely information on 

malfunctions related to certain recalls to 

ensure that the recall has been 

appropriately classified and that the 

recall strategy is effective. 

FDA also provides the following 

responses to the additional specific 

issues raised in the comments: (a) For 

the reasons discussed above, FDA 

continues to believe that it is important 

for malfunctions related to certain 

recalls to be reported as individual 

MDRs. However, after considering the 

comments, FDA has determined that 

this individual reporting condition 

should only apply to reportable 

malfunctions that are the subject of a 

recall involving a correction or removal 

that must be reported to FDA under part 

806 (21 CFR part 806). Under part 806, 

manufacturers and importers are 

required to make a written report to 

FDA of any correction or removal of a 

device if the correction or removal was 

initiated to reduce a risk to health posed 

by the device or to remedy a violation 

of the FD&C Act caused by the device 

that may present a risk to health, unless 

the information has already been 

submitted to FDA in accordance with 

other reporting requirements. (See 

§ 806.10(a) and (f).) Because the 

definition of ‘‘risk to health’’ under part 

806 tracks the definitions of class I and 

class II recalls in § 7.3(m) (21 CFR 

7.3(m)), reports of corrections and 

removals are required for actions that 

meet the definition of class I and class 

II recalls. However, under part 806, 

manufacturers and importers need not 

report events that are categorized as 

class III recalls under § 7.3(m) (see 62 

FR 27183, May 19, 1997). Therefore, an 

action that meets the definition of a 

class III recall would not, on its own, 

trigger the requirement to submit 

individual reports under the Voluntary 

Malfunction Summary Reporting 

Program. 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40977 

(b) FDA agrees that it is important to 

provide clarity regarding when the 

requirement to submit individual MDRs 

is triggered under this individual 

reporting condition and the events to 

which that requirement applies. 

Therefore, FDA is revising the 

alternative to clarify that, as of the date 

a manufacturer submits a required 

report of a correction or removal under 

part 806 (or the date that the 

manufacturer submits a report of the 

correction or removal under 21 CFR part 

803 or part 1004 instead, as permitted 

under § 806.10(f)), the manufacturer 

must submit reportable malfunction 

events related to that correction or 

removal as individual MDRs in 

accordance with §§ 803.50 and 803.52. 

We believe these revisions will help 

provide manufacturers with a clear date 

on which this individual reporting 

obligation is triggered. 

With respect to malfunction events 

that were identified for inclusion in a 

summary report but are subsequently 

identified as the subject of a reportable 

correction or removal prior to the end of 

the relevant summary reporting period, 

FDA is revising the alternative to state 

that a summary MDR must be submitted 

for those reportable malfunctions within 

30 calendar days of when the 

manufacturer submits the required 

report of correction or removal. In the 

summary report, the manufacturer must 

include a check on the box for ‘‘Recall’’ 

in SECTION H.7 of the electronic Form 

FDA 3500A. We have similarly revised 

the description of individual reporting 

conditions 3 and 4 to clarify the 

requirements for handling malfunction 

events identified for inclusion in a 

summary report (but not yet submitted) 

prior to the date that individual 

reporting is triggered. 

(c) As part of its recall termination 

process, FDA considers MDR 

information, including reported 

malfunctions to help evaluate the 

effectiveness of the recall. Therefore, 

FDA disagrees with the suggestion to 

limit the duration of individual 

reporting under this condition to 90 

days past the date of a recall. However, 

after considering the comments, we do 

not believe it is necessary to receive 

individual MDRs for reportable 

malfunction events that are the subject 

of a recall after FDA has terminated the 

recall. We have revised the alternative 

accordingly (see Section IV.B.2.). For 

similar reasons, we have revised the 

first individual reporting condition to 

state that individual MDRs associated 

with a 5-day report are only required 

until the remedial action at issue is 

resolved to FDA’s satisfaction. 

(d) By ‘‘malfunction events of the 

same nature,’’ FDA means additional 

reportable malfunction events involving 

the same malfunction that prompted the 

recall. 

(Comment 9) One comment, regarding 

proposed individual reporting condition 

3, suggested that FDA provide 

information on the timing for when the 

Agency will provide written notice to a 

manufacturer that the manufacturer can 

resume participation in the Voluntary 

Malfunction Summary Reporting 

Program. 

(Response 9) FDA cannot provide a 

uniform timeframe for when the Agency 

would notify manufacturers submitting 

individual reports due to an identified 

public health issue that they can resume 

submission of summary, quarterly 

malfunction reports for those devices 

because the timing and resolution of 

public health issues is specific to each 

situation. 

(Comment 10) Three comments 

recommended that FDA clarify what 

constitutes a ‘‘new type of reportable 

malfunction’’ that is exempt from 

summary reporting. One of these 

comments indicated that FDA should 

provide additional information 

regarding when a manufacturer can 

begin submitting summary reports for 

these new types of device malfunctions. 

(Response 10) FDA disagrees that the 

meaning of the phrase ‘‘new type of 

reportable malfunction’’ was unclear in 

the proposal. Manufacturers are 

required under § 820.198 (21 CFR 

820.198) to evaluate complaints to 

determine if they represent events that 

must be reported to FDA under part 803 

or if an investigation is required. 

Through this process, if a manufacturer 

identifies a new type of reportable 

malfunction that has not previously 

been reported to FDA over the life of 

that device, this information must be 

submitted to FDA as an individual MDR 

in accordance with §§ 803.50 and 

803.52 and may not be reported to FDA 

in a summary malfunction report. This 

will allow FDA and manufacturers to 

better understand and address emergent 

issues with medical devices. We have 

revised this individual reporting 

condition to clarify that after 

manufacturers submit an individual 

MDR for the initial occurrence of a 

previously unreported type of reportable 

malfunction for a device, subsequent 

reports for that same type of 

malfunction for that device may be in 

summary form, unless they are subject 

to individual reporting for another 

reason. 

D. Reporting Format 

(Comment 11) Some comments 

suggested that FDA allow manufacturers 

to ‘‘bundle together’’ reportable 

malfunction events in a summary report 

by product code or product family and 

allow the use of International Medical 

Device Regulators Forum’s (IMDRF) 

Level 1,2 codes to bundle like events in 

a summary report. 

(Response 11) FDA disagrees with the 

suggestion that manufacturers be 

permitted to bundle reportable 

malfunction events by product code or 

product family for purposes of 

submitting a summary report. Each 

unique combination of device brand 

name (corresponding to SECTION D1 of 

the Form FDA 3500A), device model, 

and device problem code(s) 

(corresponding to SECTION F10/H6 of 

the Form FDA 3500A) can be 

summarized together in reports 

submitted under this program. 

(Comments regarding the number of 

brand names that should be included in 

each summary report are further 

addressed in the response to Comment 

16 below, and we have made corrections 

to the summary reporting instructions 

for SECTION D.4 to be clear that each 

summary malfunction report should 

summarize events for a single device 

model.) Bundling together malfunction 

reports by product codes or device 

families would make summarizing and 

interpreting the information in a 

summary report difficult for 

manufacturers, FDA, and the public 

because a product code or product 

family could contain several devices 

with different functions, components, 

and modes of operation that are 

important for purposes of understanding 

malfunction events and the causes of 

those events. The intent of the 

Voluntary Malfunction Summary 

Reporting Program is to streamline 

reporting of events that are the same or 

similar, yet not to over bundle reports 

such that important details regarding 

device performance are obscured. 

The IMDRF (Ref. 5) is working 

towards harmonization of all medical 

device coding, including device 

problem codes. To harmonize medical 

device coding globally, device problem 

codes have been organized in a 

hierarchical arrangement, such that 

higher level codes (e.g., electrical issue) 

describe more general device problems, 

while lower level codes (e.g., insulation 

issue) provide more granularity into the 

type of device problem described. For 

purposes of grouping device issues for 

reports submitted under this Voluntary 

Malfunction Summary Reporting 

Program, we recommend that all coding 


daltland on DSKBBV9HB2PROD with RULES
40978 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 

be grouped at the lowest level of coding 

available, when IMDRF codes are 

available. Based on our experience, FDA 

does not believe grouping by the lowest 

level of coding will eliminate the 

efficiency benefits of summary 

reporting. FDA does not specify a 

specific level of coding, but expects the 

most specific appropriate code to be 

used. 

(Comment 12) One comment noted 

that it was unclear whether a summary 

malfunction report will be available in 

MAUDE or another database. Another 

comment recommended that FDA allow 

Excel spreadsheets with malfunction 

report data to be uploaded to MAUDE. 

(Response 12) FDA plans to make 

summary reports submitted under the 

Voluntary Malfunction Summary 

Reporting Program publicly available in 

MAUDE. However, FDA will not upload 

Excel spreadsheets to MAUDE because 

they are incompatible with the MAUDE 

interface. 

(Comment 13) One comment 

indicated that FDA should consider 

amending the requirement that an 

individual process the complaints 

twice—once for reporting assessment 

and then quarterly. 

(Response 13) FDA disagrees with this 

comment. FDA is granting an alternative 

to the individual reporting requirements 

under part 803 for certain reportable 

malfunction events. The Quality System 

(QS) regulation requires manufacturers 

to evaluate all complaints to determine 

if they represent events that must be 

reported to FDA under part 803 

(§ 820.198(a)). If a complaint represents 

an MDR reportable event, then the 

manufacturer must, among other things, 

investigate it and submit an MDR to 

FDA. (See §§ 803.10(c), 803.50, and 

820.198(d)) The difference for 

manufacturers that have been granted 

the alternative described in this 

document is that they could choose to 

report certain malfunction events to 

FDA as a summary report instead of as 

an individual report. 

(Comment 14) One comment 

requested that FDA provide more detail 

concerning the terms ‘‘similar device’’ 

and ‘‘similar complaint,’’ as used in the 

discussion of the rationale for the 

proposed summary reporting format. 

(Response 14) The term ‘‘similar 

device’’ is used in FDA’s MDR 

regulations to describe malfunction 

events for which manufacturers must 

submit a report to FDA. (see e.g., 

§ 803.50(a)(2)) As used in this 

alternative, the term ‘‘similar device’’ is 

intended to have the same meaning as 

it does for purposes of part 803. FDA’s 

MDR Guidance (Ref. 3), provides more 

information regarding the factors that 

FDA and manufacturers may consider in 

determining if a device is ‘‘similar’’ to 

another device. 

FDA does not believe it is necessary 

to provide a formal definition of the 

term ‘‘similar complaint’’ for purposes 

of this alternative because that term is 

not used in describing any of the 

conditions of the Voluntary Malfunction 

Summary Reporting Program, including 

the required reporting format. Whether 

a complaint constitutes a ‘‘similar 

complaint’’ for purposes of conducting 

an investigation under FDA’s QS 

regulation is outside the scope of this 

alternative. 

(Comment 15) One comment asked 

FDA to provide further information on 

how a manufacturer is to provide 

supplemental information, including 

whether FDA expects such information 

to be shared with the Agency. Some 

comments also noted that FDA should 

explain how a previously submitted 

summary malfunction report should be 

updated with new information, 

including how to handle new 

information regarding a previously 

reported event that would change the 

categorization of the event (e.g., if the 

manufacturer subsequently became 

aware that a serious injury was 

associated with a previously reported 

malfunction event). 

(Response 15) FDA understands the 

need for clarification of how to handle 

additional information and 

supplemental reporting under this 

program and has revised the alternative 

to address this issue. A manufacturer 

participating in the Voluntary 

Malfunction Summary Reporting 

Program must submit an initial 

summary report within the Summary 

Malfunction Reporting Schedule 

timeframe described in table 1. 

Supplemental reports to a summary 

malfunction report must also be 

submitted within that timeframe. For 

example, if a manufacturer submits a 

summary report for certain malfunction 

events of which it became aware in 

January to March and in May of that 

same year becomes aware of additional 

information that would have been 

required in the initial summary report if 

it had been known to the manufacturer, 

then the manufacturer must submit a 

supplemental report with that 

additional information by July 31. 

Manufacturers do not need to submit a 

supplemental report for new 

information if they would not have been 

required to report that information had 

it been known or available at the time 

of filing the initial summary 

malfunction report. 

However, this timing for 

supplemental reports would not apply 

when additional information is learned 

about an event or events included in a 

previously submitted summary report 

that triggers individual reporting 

requirements. For example, if the 

manufacturer becomes aware of 

additional information reasonably 

suggesting that a previously reported 

malfunction meets the criteria for a 

reportable serious injury or death event, 

then the manufacturer must submit an 

initial, individual MDR for the 

identified serious injury or death within 

30 calendar days of becoming aware of 

the additional information. The 

manufacturer must simultaneously 

submit a supplement to the initial MDR 

summary report reducing the number of 

events summarized by 1, so that the 

total number of events remains the 

same. The alternative has been revised 

to reflect that these are requirements for 

participating in the Voluntary 

Malfunction Summary Reporting 

Program. 

(Comment 16) One comment stated 

that Form FDA 3500A is not an optimal 

format because it is only used for single 

event reporting. Other comments made 

specific recommendations and/or raised 

issues regarding the proposed summary 

reporting format using Form FDA 

3500A, including the following: (a) In 

Form FDA 3500A, SECTIONS B.5 and 

H.10, FDA should request that 

information be entered in a summary, 

high-level form, rather than requiring 

detailed descriptions or itemized 

investigation findings; (b) clarify the 

most ‘‘up to date’’ information that is 

expected to be received in the report; (c) 

clarify that only one brand name per 

product code should be entered in the 

field with additional brand names being 

provided in a separate attachment 

(SECTION D.1); (d) inclusion of patient 

age, weight, and breakdown of gender 

and race is inappropriate for summary 

malfunction reporting, and it is not clear 

if such information is required in a 

summary malfunction report; (e) clarify 

that manufacturers can submit summary 

malfunction reports for devices 

manufactured at multiple 

manufacturing sites (SECTION D.3); (f) 

the summary format should permit a 

serial number to be used instead of a lot 

number to identify the devices that are 

the subject of a summary report 

(SECTION D.4); and (g) address how a 

manufacturer should link a device 

problem code with a method code, 

result code, and evaluation conclusion 

code (if different) for a single summary 

report that includes more than one 

device problem. 

(Response 16) FDA does not believe 

the summary reporting format should be 

changed to use a new form. The 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40979 

Voluntary Malfunction Summary 

Reporting Program aims to, among other 

things, consolidate reporting of same or 

similar events into a single summary 

report to reduce the overall volume of 

reports, while still providing critical 

content to FDA. While the Form FDA 

3500A was developed for individual 

MDRs, manufacturers successfully used 

the Form FDA 3500A to submit 

summary malfunction reports in FDA’s 

pilot program. In addition, as explained 

in our 2017 Proposal, for purposes of 

streamlining changes that FDA and 

manufacturers must make to process or 

submit summary reports under the 

Voluntary Malfunction Summary 

Reporting Program, we believe that 

using the Form FDA 3500A is the most 

efficient approach. We provide the 

following responses to the specific 

recommendations/issues raised 

regarding the summary reporting format: 

(a) FDA continues to believe that it is 

important for summary malfunction 

reports submitted under this program to 

provide a similar level of detail in text 

narratives as is available in an 

individual report to allow for sufficient 

understanding of the malfunction, any 

circumstances that led to the 

malfunction, and any follow-up steps 

the manufacturer has taken to 

investigate, correct, and prevent the 

malfunction from happening again. 

These narrative text fields are key to 

helping ensure that summary reporting 

under this program streamlines 

malfunction reporting without reducing 

the reporting of important details 

regarding device performance and 

transparency to the public. (b) Each 

summary report must be ‘‘up to date,’’ 

meaning that it must include all 

required information available, as of the 

close of the quarterly time period listed 

in the Summary Malfunction Reporting 

Schedule (see table 1). FDA has clarified 

this in section IV.F. (c) FDA disagrees 

that separate attachments with 

additional brand names should be 

permitted to accompany a summary 

malfunction report. Each summary 

malfunction report may only summarize 

malfunction events for a single brand 

name. We further clarified this in the 

instructions for the summary reporting 

format at section IV.D. Including 

multiple brand names in an attachment 

to a single summary report would, 

among other things, result in FDA 

having difficulty identifying the specific 

malfunction event to the exact device 

brand. (d) FDA agrees that information 

summarizing patient age, weight, 

gender, race, and ethnicity may not be 

relevant for many summary malfunction 

reports. FDA is revising the description 

of the summary reporting format to 

clarify that inclusion of this information 

in Section B.5 is not a required entry for 

the form. However, FDA recommends 

including descriptors such as patient 

weight or race in a text narrative for a 

malfunction summary report if the 

information is available and indicates 

that a malfunction is more likely to 

affect a specific group of patients. (e) 

FDA is revising the description of the 

summary reporting format to clarify that 

multiple manufacturing sites could be 

entered in SECTION G.1 if the device is 

manufactured at multiple sites. We note 

that depending on their roles, each 

manufacturing site may be responsible 

for submitting MDRs. (See e.g., section 

2.17 of FDA’s MDR Guidance (Ref. 3), 

which provides additional information 

regarding reporting obligations for 

contract manufacturers.) (f) FDA agrees 

that a serial number may be included in 

SECTION D.4 and has added ‘‘serial 

number’’ to the reporting format 

instructions for that section. (g) The 

summary reporting format requires 

firms to identify the method, result, and 

conclusion codes in Block H6 of the 

Form FDA 3500A, including as many 

codes as are necessary to describe the 

event problem and evaluation for the 

reportable malfunction events that are 

being summarized. If the report 

summarizes reportable events that 

involved more than one type of device 

problem (see e.g., Case Scenario #2, 

Report #3 in Appendix A (Ref. 6)), 

differences in the conclusion code 

according to the different device 

problems can be explained in SECTION 

H.10. 

E. Consideration of Combination 

Products 

(Comment 17) Some comments raised 

issues regarding the application of the 

malfunction summary reporting for 

combination products that contain a 

device constituent part but that are 

marketed under drug or biological 

product marketing authorization 

pathways (referred to in this document 

as drug and biologic-led combination 

products), as opposed to those under 

device marketing authorization 

pathways (device-led combination 

products). Issues raised in these 

comments include: Concerns about a 

device product code-based eligibility 

approach for drug and biologic-led 

combination products because such 

products may not have a device product 

code; the quarterly schedule proposed 

because it would create redundancies 

for drug and biologic-led combination 

products, which are subject to periodic 

reporting; the format proposed because 

it might not be compatible with the 

reporting systems for drugs or biological 

products that are utilized for drug and 

biologic-led combination products; and 

development of a single report that 

includes malfunction summary 

reporting and satisfies other 

combination product reporting 

requirements. 

(Response 17) Among other things, 

the final rule on postmarketing safety 

reporting (PMSR) for combination 

products (81 FR 92603, December 20, 

2016), codified in part 4, subpart B (21 

CFR part 4, subpart B), clarified that all 

combination product applicants must 

comply with malfunction reporting 

requirements as described in part 803 if 

their combination product contains a 

device constituent part. Accordingly, in 

the 2017 Proposal, FDA requested 

comment on how the Voluntary 

Malfunction Summary Reporting 

Program might be implemented for 

combination products, including drug 

and biologic-led combination products. 

Shortly after the issuance of the 

proposal for this program, FDA also 

published a draft guidance entitled, 

‘‘Postmarketing Safety Reporting for 

Combination Products; Guidance for 

Industry and FDA Staff’’ (PMSR draft 

guidance) (Ref. 7) regarding compliance 

with the final rule on PMSR for 

combination products, and an 

Immediately in Effect guidance 

announcing FDA’s compliance policy 

for that rule (Ref. 8). The PMSR draft 

guidance noted that the Agency was 

proposing the Voluntary Malfunction 

Summary Reporting Program and stated 

that the Agency intends to update the 

PMSR draft guidance if combination 

products are included in the program. 

The compliance policy guidance 

announced the Agency’s intent to delay 

enforcement of certain provisions of the 

rule, including malfunction reporting 

requirements for drug and biologic-led 

combination products, to provide 

applicants with additional time to 

consider Agency recommendations and 

technical specifications as they update 

their systems and procedures to comply 

with those provisions. 

Applicants of device-led combination 

products must submit MDRs in 

accordance with part 803 (see § 4.104 

(21 CFR 4.104)), and therefore, they 

report malfunctions using the same 

system as device manufacturers. Thus, 

FDA believes the eMDR data system and 

instructions support use of the 

Voluntary Malfunction Summary 

Reporting Program for such products. 

Accordingly, we are including deviceled combination products in the 

Voluntary Malfunction Summary 

Reporting Program. However, 

combination product applicants for drug 


daltland on DSKBBV9HB2PROD with RULES
40980 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 

and biologic-led combination products 

with a device constituent part must 

submit malfunction reports under a 

different system. Under § 4.104(b), 

malfunction reports must be submitted 

in accordance with 21 CFR 314.80(g) or 

600.80(h)) for these combination 

products. Additional considerations, 

including the issues raised in comments 

as discussed above, need to be 

addressed before drug and biologic-led 

combination products could be 

included in the Voluntary Malfunction 

Summary Reporting Program. As noted 

above, the Agency intends to delay 

enforcement of the malfunction 

reporting requirements for drug and 

biologic-led combination products 

under the PMSR final rule. FDA will 

consider all relevant comments 

submitted on the 2017 Proposal as well 

as those submitted on the PMSR draft 

guidance in developing an approach for 

voluntary malfunction summary 

reporting for such combination 

products. 

F. Submission Schedule and Logistics 

(Comment 18) One comment 

recommended that FDA permit 

manufacturers to submit individual 

reports for each adverse event within 90 

calendar days from the date they 

become aware of the reportable event, 

while using the summary format. The 

comment also suggested that FDA 

provide an additional 30 days for the 

submission of summary reports because 

the manufacturer may need more than a 

month between the end of the reporting 

period and the due date to aggregate 

reports. 

(Response 18) FDA disagrees with this 

comment. Permitting manufacturers to 

submit individual reports using the 

summary format within 90 calendar 

days would delay the submission of 

malfunction information to FDA 

without providing the anticipated 

benefits of summary reporting that FDA 

identified in the 2017 Proposal, such as 

increased efficiency in processing 

malfunction reports and more readily 

apparent malfunction trends. While we 

recognize that a manufacturer may 

become aware of some reportable 

malfunction events toward the end of a 

quarter, manufacturers will have at least 

30 days from that time to prepare and 

submit summary malfunction reports. 

FDA does not believe that 

manufacturers will need an additional 

30 days beyond the reporting schedule 

outlined in the 2017 Proposal to 

aggregate malfunction reports into a 

summary report. Therefore, we have 

retained the Summary Malfunction 

Reporting Schedule that was included 

in the 2017 Proposal (see table 1). 

(Comment 19) One comment 

suggested that FDA use a more generic 

reporting number format or a 

completely different reporting number 

format. 

(Response 19) FDA disagrees with this 

comment. The required reporting 

number format for this program uses the 

existing common format that 

manufacturers must use to submit 

individual reports through their 

electronic reporting systems under part 

803. Therefore, we believe there is no 

need for a separate MDR reporting 

number format to identify summary 

reports. 

(Comment 20) One comment 

suggested that FDA clarify what the 

manufacturer should do if an 

investigation is not completed within 

the reported timeframe. 

(Response 20) As discussed in 

response to Comment 15, FDA has 

revised the alternative to include 

instructions regarding supplemental 

reporting for summary reports 

submitted under this voluntary 

program. In situations where a 

manufacturer is not able to complete its 

investigation regarding a reportable 

malfunction by the deadline for 

submitting a summary report, the 

manufacturer is still required to report 

the event within the timeframes 

specified in the Summary Malfunction 

Reporting Schedule (see table 1). If 

additional information becomes known 

or available to the manufacturer after 

submission of a summary report, 

including additional information that 

becomes known through an 

investigation, the manufacturer is 

required to submit supplemental reports 

amending its initial submission as 

needed. 

G. Addition of Product Codes to the 

Program 

(Comment 21) Some comments 

suggested that FDA should explain more 

clearly how industry would make a 

request under § 803.19(b) and provide a 

mechanism for industry to request an 

exemption, when appropriate, for 

product codes that may be newly 

assigned within the first 2 years. 

(Response 21) FDA is not making any 

changes to the alternative in response to 

this comment. As discussed in section 

VI, FDA intends to periodically assess 

the eligibility of product codes after 

they have been in existence for 2 years 

and will update the FDA’s Product 

Classification database accordingly. 

Manufacturers can also send a request 

for a product code to be added to the list 

of eligible product codes and for 

manufacturers of devices within that 

product code to be granted the same 

alternative for malfunction events 

associated with those devices. 

Information about where to send such 

requests is provided in section VI. 

H. Other Comments 

(Comment 22) One comment stated 

that the average Paperwork Reduction 

Act (PRA) burden on manufacturers of 

6 minutes per response appears to be a 

very low estimate. 

(Response 22) FDA disagrees with this 

comment. The estimation of time is the 

amount of time needed to submit a 

summary malfunction report. It is 

essentially the same amount of time 

needed to submit an individual report 

because the event narrative should be 

similar, with the exception of one 

additional line that is entered that 

indicates the number of adverse events 

represented by the report. It does not 

include the time needed to evaluate and 

investigate complaints that may 

represent reportable malfunction events. 

(Comment 23) Two comments 

suggested that FDA should provide 

clarity on how the program will apply 

with national competent authorities via 

the National Competent Authority 

Report (NCAR) exchange program. 

(Response 23) FDA disagrees with this 

comment. The NCAR exchange program 

is separate from FDA’s MDR reporting 

requirements. Malfunction summary 

reporting under this program does not 

change the information shared through 

the NCAR exchange program, and the 

NCAR program is currently outside the 

scope of the Voluntary Malfunction 

Summary Reporting Program. 

(Comment 24) One comment suggests 

that FDA should use IBM’s Watson 

Platform for Health GxP (Watson) to 

conduct an analysis to identify the 

product codes that represent the largest 

opportunity described in the business 

case for patients, industry, and FDA 

instead of other database systems. 

(Response 24) FDA disagrees with this 

comment. Among other reasons, the 

IBM Watson Platform is not an FDAowned resource; therefore, it is not 

logistically feasible for FDA to use this 

platform to identify product codes 

eligible for the Voluntary Malfunction 

Summary Reporting Program at this 

time. 

III. Principles for Malfunction 

Summary Reporting 

Informed by the findings from the 

Pilot Program for Medical Device 

Reporting on Malfunctions, FDA 

identified the following overarching 

principles for summary reporting of 

malfunctions: 

• The collection of information in 

summary format should allow FDA to 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40981 

1We note that the Voluntary Malfunction 

Summary Reporting Program does not apply to 

importers or device user facilities. Therefore, 

requirements under part 803 for importers and 

device user facilities are unaffected by this 

alternative. For example, importers will continue to 

submit individual MDRs to the manufacturer under 

§ 803.40. 

collect sufficient detail to understand 

reportable malfunction events. 

• To increase efficiency, summary 

malfunction reporting should occur in a 

common format for the electronic 

reporting system used. 

• Information about reportable 

malfunctions should be transparent to 

FDA and to the public, regardless of 

whether the information is reported as 

an individual MDR or a summary 

report. Information contained in a 

summary malfunction report that is 

protected from public disclosure under 

applicable disclosure laws would be 

redacted prior to release of the report. 

• Manufacturers should communicate 

information regarding an imminent 

hazard at the earliest time possible. 

• Summary reporting is meant to 

streamline the process of reporting 

malfunctions. It does not change 

regulatory requirements for MDR-related 

investigations or recordkeeping by 

manufacturers. (For example, 

manufacturers participating in the 

Voluntary Malfunction Summary 

Reporting Program remain subject to 

requirements for establishing and 

maintaining MDR event files under 

§ 803.18. In addition, under the QS 

regulation, manufacturers must 

evaluate, review, and investigate any 

complaint that represents an MDR 

reportable event (see § 820.198). 

• Summary reporting information 

should not be duplicative of information 

received through other MDR reporting 

processes. 

IV. Voluntary Malfunction Summary 

Reporting Program 

For the reasons discussed in the 2017 

Proposal and in section II, the Agency 

has determined that, at this time, 

pursuant to section 519(a)(1)(B)(i)(III) of 

the FD&C Act, all devices should remain 

subject to the reporting requirements of 

part 803, to protect the public health. 

However, based on the findings from the 

2015 Pilot Program, the Agency’s 

experience with summary reporting 

programs, its experience with MDR 

reporting generally, and the comments 

received on 2017 Proposal, FDA has 

determined that for many devices, it is 

appropriate to permit manufacturers to 

submit malfunction summary reports on 

a quarterly basis, for certain 

malfunctions, instead of individual, 30- 

day malfunction reports. 

Therefore, under § 803.19, FDA is 

granting the manufacturers of devices 

within eligible product codes, as 

identified in FDA’s Product 

Classification Database (https://

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfPCD/classification.cfm) on 

August 17, 2018, an alternative to the 

reporting requirements at 

§§ 803.10(c)(1), 803.20(b)(3)(ii), 

803.50(a)(2), 803.52, and 803.56 with 

respect to reportable malfunction events 

associated with those devices. The list 

reflects FDA’s consideration of a list 

proposed by industry representatives, 

consistent with the MDUFA IV 

Commitment Letter, as well as the 

comments received on the 2017 

Proposal regarding eligible product 

codes. To assist manufacturers and the 

public in identifying which product 

codes are eligible for participation in 

this voluntary program, FDA’s 

searchable Product Classification 

Database (https://www.accessdata.fda.

gov/scripts/cdrh/cfdocs/cfPCD/ 

classification.cfm) has been updated to 

reflect such eligibility. As discussed in 

section II, FDA is also making some 

changes to the conditions of the 

alternative after considering the 

comments received on the 2017 

Proposal. 

The alternative permits manufacturers 

of devices within eligible product codes 

to submit malfunction reports in 

summary format on a quarterly basis for 

those devices, subject to the conditions 

of the alternative described in the 

remainder of this section. Such 

manufacturers ‘‘self-elect’’ to participate 

by submitting summary malfunction 

reports in accordance with the 

conditions of the alternative. They do 

not need to submit a separate 

application to FDA to participate.1

The remainder of this section 

describes the following conditions that 

manufacturers must follow if they 

choose to submit summary malfunction 

reports for devices within eligible 

product codes under the alternative: (1) 

The conditions under which individual 

malfunction reports are required; (2) 

submission of supplemental reports; (3) 

the format for summary malfunction 

reports; (4) considerations for 

combination products; and (5) the 

schedule and other logistics for 

submission of summary reports. 

Because this is an alternative, if a 

manufacturer does not submit summary 

reports for reportable malfunction 

events in accordance with the 

conditions described in this section, 

including the reporting schedule and 

format, then the manufacturer must 

submit individual malfunction reports 

in compliance with all requirements 

under part 803 (unless the manufacturer 

has been granted a different exemption, 

variance, or alternative that applies). 

A. Events Outside the Scope of This 

Alternative 

The Voluntary Malfunction Summary 

Reporting Program does not apply to 

reportable death or serious injury 

events, which are still required to be 

reported to FDA within the mandatory 

30-calendar-day timeframe, under 

§§ 803.50 and 803.52, or within the 5- 

work day timeframe under § 803.53. 

Thus, if a manufacturer participating in 

the program becomes aware of 

information reasonably suggesting that a 

device that it markets may have caused 

or contributed to a death or serious 

injury, then the manufacturer must 

submit an individual MDR for that event 

because it involves a reportable death or 

serious injury. 

The reporting requirements at 

§ 803.53 also continue to apply to 

manufacturers participating in the 

program. Under § 803.53(a), a 5-day 

report must be filed if a manufacturer 

becomes aware of an MDR reportable 

event that necessitates remedial action 

to prevent an unreasonable risk of 

substantial harm to the public health. 

Further, under § 803.53(b), if FDA has 

made a written request for the 

submission of a 5-day report, the 

manufacturer must submit, without 

further requests, a 5-day report for all 

subsequent reportable malfunctions of 

the same nature that involve 

substantially similar devices for the 

time period specified in the written 

request. FDA may extend the time 

period stated in the original written 

request if the Agency determines it is in 

the interest of the public health (see 

§ 803.53(b)). 

B. Individual Reporting Conditions 

Manufacturers of devices in eligible 

product codes may continue submitting 

individual, 30-day malfunction reports 

in compliance with §§ 803.50 and 

803.52 if they choose to do so. However, 

those manufacturers may submit all 

reportable malfunction events for 

devices in eligible product codes in the 

summary format and according to the 

schedule described below in section 

IV.D and F, unless one of the following 

individual reporting conditions applies: 

1. A Reportable Malfunction Is 

Associated With a 5-Day Report 

After submitting a 5-day report 

required under § 803.53(a), all 

subsequent reportable malfunctions of 

the same nature that involve 

substantially similar devices must be 

submitted as individual MDRs in 


daltland on DSKBBV9HB2PROD with RULES
40982 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 

2FDA regulations provide that ‘‘[e]ach device 

manufacturer or importer shall submit a written 

report to FDA of any correction or removal of a 

device initiated by such manufacturer or importer 

if the correction or removal was initiated: (1) To 

reduce a risk to health posed by the device or (2) 

to remedy a violation of the act caused by the 

device which may present a risk to health unless 

the information has already been provided as set 

forth in paragraph (f) of this section or the 

corrective or removal action is exempt from the 

reporting requirements under § 806.1(b).’’ We note 

that under part 806, manufacturers and importers 

are not required to report a correction or removal 

that meets the definition of a class III recall under 

21 CFR part 7. (See 21 CFR 7.3(g) and (m), 806.2(d) 

and (j) through (k), and 806.10; see also 62 FR 

27183 at 27184.) 

compliance with §§ 803.50 and 803.52 

until the date that the remedial action 

has been terminated to FDA’s 

satisfaction. Summary reporting of 

malfunctions may then resume on the 

regularly scheduled summary reporting 

cycle. Submission of reportable 

malfunctions associated with 5-day 

reports in this manner will assist FDA 

in monitoring the time course and 

resolution of the issue presenting an 

unreasonable risk of substantial harm to 

the public health. 

2. A Reportable Malfunction Is the 

Subject of Certain Device Recalls 

When a device is the subject of a 

recall involving the correction or 

removal of the device to address a 

malfunction and that correction or 

removal is required to be reported to 

FDA under part 806,2 all reportable 

malfunction events of the same nature 

that involve the same device or a similar 

device marketed by the manufacturer 

must be submitted as individual MDRs 

in accordance with §§ 803.50 and 

803.52 until the date that the recall is 

terminated. After the recall is 

terminated, summary reporting may 

resume on the regularly scheduled 

summary reporting cycle. The 

requirement to submit individual 

reports under this condition is triggered 

on the date that the manufacturer 

submits a report of a correction or 

removal required under part 806 (or the 

date that the manufacturer submits a 

report of the correction or removal 

under part 803 or part 1004 instead, as 

permitted under § 806.10(f)). This will 

allow FDA to monitor the frequency of 

reportable malfunctions associated with 

the recall and effectiveness of the recall 

strategy. 

If a manufacturer becomes aware of 

reportable malfunction events before the 

date that the requirement to submit 

individual reports is triggered and a 

summary report for those events has not 

yet been submitted to FDA, then the 

manufacturer must submit any of those 

malfunction events related to the recall 

in a summary MDR format within 30 

calendar days of submitting the required 

report of correction or removal. In the 

summary MDR, the manufacturer must 

include a check box of recall in section 

H.7 of the electronic Form FDA 3500A. 

3. FDA Has Determined That Individual 

MDR Reporting Is Necessary To Address 

a Public Health Issue 

If FDA has determined that individual 

malfunction reports are necessary to 

provide additional information and 

more rapid reporting for an identified 

public health issue involving certain 

devices, manufacturers must submit 

reportable malfunction events for those 

devices as individual MDRs in 

compliance with §§ 803.50 and 803.52. 

Under these circumstances, FDA will 

provide written notification to 

manufacturers of relevant devices that 

individual MDR submissions are 

necessary. FDA will provide further 

written notice when manufacturers of 

those devices may resume participation 

in summary malfunction reporting. 

The requirement to submit individual 

reports under this condition is triggered 

on the date the manufacturer receives 

the written notification from FDA. If a 

manufacturer became aware of 

reportable malfunction events before the 

date that the requirement to submit 

individual reports is triggered and a 

summary report for those events has not 

yet been submitted to FDA, then the 

manufacturer must submit any of those 

malfunction events for the identified 

devices to FDA within 30 calendar days 

of receiving notification from FDA. 

4. FDA Has Determined That a Device 

Manufacturer May Not Report in 

Summary Reporting Format 

FDA may determine that a specific 

manufacturer is no longer allowed to 

participate in the Voluntary 

Malfunction Summary Reporting 

Program for reasons including, but not 

limited to, failure to comply with 

applicable MDR requirements under 

part 803, failure to follow the conditions 

of the program, or the need to monitor 

a public health issue. In that case, FDA 

will provide written notification to the 

device manufacturer to submit 

individual malfunction reports in 

compliance with §§ 803.50 and 803.52. 

The requirement to submit individual 

reports under this condition is triggered 

on the date the manufacturer receives 

the written notification from FDA. If a 

manufacturer became aware of 

reportable malfunction events before the 

date that the requirement to submit 

individual reports is triggered under 

this condition and a summary report for 

those events has not yet been submitted 

to FDA, then the manufacturer must 

submit those malfunction events within 

30 calendar days of receiving 

notification from FDA. 

5. A New Type of Reportable 

Malfunction Occurs for a Device 

If a manufacturer becomes aware of 

information reasonably suggesting a 

reportable malfunction event has 

occurred for a device that the 

manufacturer markets and the 

reportable malfunction is a new type of 

malfunction that the manufacturer has 

not previously reported to FDA for that 

device, then the manufacturer must 

submit an individual report for that 

reportable malfunction in compliance 

with §§ 803.50 and 803.52. After the 

manufacturer submits this initial 

individual report, subsequent 

malfunctions of this type may be 

submitted in summary form according 

to the reporting schedule in table 1, 

unless another individual reporting 

condition applies. 

C. Supplemental Reports 

In general, if a manufacturer obtains 

information required in a malfunction 

summary report (see section IV.D. 

describing the required content of a 

summary report), that the manufacturer 

did not provide because it was not 

known or was not available when the 

manufacturer submitted the initial 

summary malfunction report, the 

manufacturer must submit the 

supplemental information to FDA in an 

electronic format in accordance with 

§ 803.12(a). The supplemental 

information must be submitted to FDA 

by the submission deadline described in 

the Summary Malfunction Reporting 

Schedule (table 1), according to the date 

on which the manufacturer becomes 

aware of the supplemental information. 

Manufacturers must continue to follow 

the requirements for the content of 

supplemental reports set forth at 

§ 803.56(a) thorough (c), meaning that 

on a supplemental or follow up report, 

the manufacturer must: (a) Indicate that 

the report being submitted is a 

supplemental or follow up report; (b) 

submit the appropriate identification 

numbers of the report that you are 

updating with the supplemental 

information (e.g., your original 

manufacturer report number and the 

user facility or importer report number 

of any report on which your report was 

based), if applicable; and (c) include 

only the new, changed, or corrected 

information. 

However, if a manufacturer submits a 

summary malfunction report and 

subsequently becomes aware of 

information reasonably suggesting that 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40983 

an event (or events) summarized therein 

represents a reportable serious injury or 

death event, or a new type of reportable 

malfunction, then the manufacturer 

must submit reports as follows: The 

manufacturer must submit an initial, 

individual MDR for the identified 

serious injury, death, or new type of 

reportable malfunction event within 30 

calendar days of becoming aware of the 

additional information. The 

manufacturer must simultaneously 

submit a supplement to the initial 

malfunction summary report reducing 

the number of events summarized 

accordingly, so that the total number of 

events remains the same. 

D. Malfunction Reporting Summary 

Format 

Manufacturers of devices in eligible 

product codes who elect to participate 

in the Voluntary Malfunction Summary 

Reporting Program must submit 

summary malfunction reports in the 

format described below. As detailed in 

the 2017 Proposal and Appendix, the 

format largely adopts the format that 

was tested in FDA’s Pilot Program for 

Medical Device Reporting on 

Malfunctions and is compatible with the 

Form FDA 3500A (Ref. 9), which allows 

manufacturers to submit MDRs using 

the same electronic submission form 

that they use to submit individual 

MDRs, in accordance with the eMDR 

Final Rule (79 FR 8832, February 14, 

2014). Because summary malfunction 

reports represent a grouping of 

malfunction events for a specific model 

of a device, the summary reporting 

format would require an additional 

element in the summary text narrative 

to identify the number of reportable 

malfunctions that each report 

represents. As described below, the 

XML tags ‘‘<NOE>’’ and ‘‘<NOE/>’’ are 

placed on both sides of the number of 

events (NOE) to make the number 

extractable from the report. FDA 

believes that submission of summary 

reports in the format described below 

will provide the most compact and 

efficient reporting mechanism for 

streamlining malfunction reporting that 

still provides sufficient detail for FDA to 

monitor devices effectively. 

Format Instructions: Separate 

summary malfunction reports must be 

submitted for each unique combination 

of brand name, device model, and 

problem code(s). (See Appendix A for 

case examples of how to report (Ref. 6).) 

Each summary malfunction report must 

include at least the following 

information collected on Form FDA 

3500A and must be submitted in an 

electronic format: 

• SECTION B.5: Describe Event or 

Problem—To distinguish this report as a 

summary malfunction report, the first 

sentence of the device event narrative 

must read: ‘‘This report summarizes 

<NOE> XXX </NOE> malfunction 

events,’’ where XXX is replaced by the 

number of malfunction events being 

summarized. 

The device event narrative must then 

include a detailed description of the 

nature of the events and, if relevant and 

available, we recommend including a 

range of patient age and weight and a 

breakdown of patient gender, race, and 

ethnicity. 

• SECTION D.1: Brand Name. 

• SECTION D.2 and D.2.b: Common 

Device Name and Product Code. Include 

the common name of the device and 

Product Classification Code (Procode). 

• SECTION D.3: Manufacturer Name, 

City, and State. 

• SECTION D.4: Device 

Identification—Enter the model and/or 

catalog number and lot number(s) and/ 

or serial number(s) for the devices that 

are the subject of the MDR. Include any 

device identifier (DI) portion of the 

unique device identifier (UDI) for the 

device version or model that is the 

subject of the MDR. 

• SECTION G.1: Contact Office (and 

Manufacturing Site(s) for Devices)— 

Enter the name, address, and email of 

the manufacturer reporting site (contact 

office), including the contact name for 

the summary report being submitted. 

Enter the name and address of the 

manufacturing site(s) for the device, if 

different from the contact office. 

• SECTION G.2: Phone Number of 

Contact Office. 

• SECTION G.5: Combination 

Products—If applicable, indicate that 

the report involves a combination 

product (see section IV.E.). 

• SECTION H.1: Type of Reportable 

Event—Check ‘‘Malfunction’’ in this 

box. 

• SECTION H.6: Event Problem and 

Evaluation Codes— 

Æ Enter the device problem code(s). 

(See Appendix A for case examples of 

how to report (Ref. 6).) 

Æ Enter the evaluation code(s) for the 

following categories: Method, Results, 

Conclusion. 

Æ Enter a Conclusion Code, even if 

the device was not evaluated. 

• SECTION H.10: Additional 

Manufacturer Narrative—Provide a 

summary of the results of the 

investigation for the reported 

malfunctions, including any follow up 

actions taken, and any additional 

information that would be helpful in 

understanding how the manufacturer 

addressed the malfunction events 

summarized in the report. Enter a 

breakdown of the malfunction events 

summarized in the report, including the 

number of devices that were returned, 

the number of devices that were labeled 

‘‘for single use’’ (if any), and the number 

of devices that were reprocessed and 

reused (if any). 

E. Combination Product Considerations 

As noted in the response to comment 

17 above, device-led combination 

products are included in this alternative 

that we are granting under § 803.19 to 

permit voluntary malfunction summary 

reporting. The eMDR data system and 

instructions support use of the 

Voluntary Malfunction Summary 

Reporting Program for device-led 

combination products. However, as 

discussed in response to comment 17 

above, additional considerations need to 

be addressed before drug and biologicled combination products could be 

included in the Voluntary Malfunction 

Summary Reporting Program. As noted 

in Response 17, the Agency intends to 

delay enforcement of the malfunction 

reporting requirements for drug and 

biologic-led combination products 

under the PMSR final rule. FDA will 

consider the relevant comments 

received on the 2017 Proposal, as well 

as any additional, relevant comments 

relating to malfunction reporting for 

drug and biologic-led combination 

products submitted in relation to the 

PMSR draft guidance in developing an 

approach for voluntary malfunction 

summary reporting for such 

combination products. 

F. Submission Schedule and Logistics 

Manufacturers submitting 

malfunction summary reports or 

supplemental reports to a malfunction 

summary report must use electronic 

reporting (Ref. 10) to submit those 

reports on a quarterly basis according to 

the schedule in table 1. The summary 

malfunction report must include the 

MDR Number, which consists of the 

registration number of the manufacturer, 

the year in which the event is being 

reported, and a 5-digit sequence 

number. Information included in a 

malfunction summary report must be 

current as of the last date of the 

quarterly timeframe identified in the 

first column of table 1. 


daltland on DSKBBV9HB2PROD with RULES
40984 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 

TABLE 1—SUMMARY MALFUNCTION REPORTING SCHEDULE

Reportable malfunctions or supplemental information that you become aware of during these timeframes: Must be submitted to FDA 

by: 

January 1–March 31 ....................................................................................................................................................... April 30. 

April 1–June 30 ............................................................................................................................................................... July 31. 

July 1–September 30 ...................................................................................................................................................... October 31. 

October 1–December 31 ................................................................................................................................................ January 31. 

The Voluntary Malfunction Summary 

Reporting Program applies only to 

reportable malfunction events that 

manufacturers become aware of on or 

after August 17, 2018. The deadline for 

FDA accepting the first round of 

quarterly reports for this program is 

October 31, 2018. 

Under §§ 803.17 and 803.18, 

manufacturers are required to develop, 

maintain, and implement written MDR 

procedures and establish and maintain 

MDR event files, and those requirements 

remain applicable for manufacturers 

that elect to participate in this program. 

Among other things, a manufacturer 

must develop, maintain, and implement 

MDR procedures that provide for timely 

transmission of complete MDRs to FDA. 

(See § 803.17(a)(3)). Manufacturers 

participating in the Voluntary 

Malfunction Summary Reporting 

Program will need to update their 

internal MDR processes and procedures 

to provide for submitting summary 

malfunction reports within the 

Summary Malfunction Reporting 

Schedule. 

V. Implementation Strategy 

The goal of the Voluntary Malfunction 

Summary Reporting Program is to 

permit manufacturers of devices under 

certain product codes to report 

malfunctions on a quarterly basis and in 

a summary format, as outlined in the 

MDUFA IV Commitment Letter (Ref. 1), 

in a manner that provides for effective 

monitoring of devices and is beneficial 

for FDA, industry, and the public. An 

important part of this voluntary program 

is providing clarification to 

manufacturers regarding the product 

codes eligible for the program. 

Consistent with the MDUFA IV 

Commitment Letter (Ref. 1), FDA has 

identified eligible product codes for the 

Voluntary Malfunction Summary 

Reporting Program in FDA’s Product 

Classification Database, available on 

FDA’s website, as part of granting the 

alternative (see https://

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfPCD/classification.cfm). 

Manufacturers that choose to participate 

in quarterly, summary reporting through 

this program will remain responsible for 

complying with applicable MDR 

requirements under part 803 (e.g., 

requirements to establish and maintain 

MDR event files under § 803.18) and QS 

requirements under part 820 (21 CFR 

part 820) (e.g., the requirement to 

evaluate, review, and investigate any 

complaint that represents an MDR 

reportable event under § 820.198). 

If FDA determines that individual 

malfunction reports are necessary from 

a specific manufacturer or for specific 

devices, FDA will notify relevant 

manufacturers that they must submit 

individual reports and provide an 

explanation for that decision and, as 

appropriate, the steps necessary to 

return to summary, quarterly reporting. 

The Agency also notes that, under 

§ 803.19(d), it may revoke or modify in 

writing an exemption, variance, or 

alternative reporting requirement if it 

determines that revocation or 

modification is necessary to protect the 

public health. 

VI. Updating Product Codes for 

Inclusion Into the Program 

FDA recognizes that new product 

codes will be created after the date of 

granting the Voluntary Malfunction 

Summary Reporting Program alternative 

under § 803.19. In general, FDA does 

not intend to consider devices under 

product codes in existence for less than 

2 years to be eligible for the program, 

unless the new product code was issued 

solely for administrative reasons. Any 

product code in existence after the 

publication date will be initially 

ineligible to participate in the program. 

However, FDA will periodically 

evaluate new product codes after they 

have been in existence for 2 years to 

determine whether they should be 

added to the list of product codes 

eligible for the Voluntary Malfunction 

Summary Reporting Program. If FDA 

determines that a new product code 

should be added, then it will grant 

manufacturers of devices within that 

product code the same alternative under 

§ 803.19 for malfunction events 

associated with those devices and 

update FDA’s Product Classification 

database accordingly to reflect the 

changes. 

Manufacturers can send a request for 

a product code to be added to the list 

of eligible product codes and for 

manufacturers of devices within that 

product code to be granted the same 

alternative for malfunction events 

associated with those devices to the 

MDRPolicy@fda.hhs.gov mailbox. You 

may also mail your written request to 

MDR Policy Branch, Division of 

Postmarket Surveillance, Office of 

Surveillance and Biometrics, Center for 

Devices and Radiological Health, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

3217, Silver Spring, MD 20993–0002. 

VII. Conclusion 

In accordance with section 

519(a)(1)(B)(i) of the FD&C Act and 

§ 803.19, FDA is granting the alternative 

described in section IV to manufacturers 

of devices in eligible product codes, as 

identified in the FDA Product 

Classification Database (https://

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfPCD/classification.cfm) on 

August 17, 2018. FDA believes that for 

the devices in eligible product codes, 

quarterly, summary reporting in 

accordance with the conditions of the 

alternative will be as effective as the 

current MDR regulatory requirements 

for purposes of identifying and 

monitoring potential device safety 

concerns and device malfunctions. The 

Voluntary Malfunction Summary 

Reporting Program will allow 

manufacturers to submit summary 

reports with event narratives that will 

help FDA more efficiently process 

malfunction reports and identify 

malfunction trends. In addition, FDA’s 

determination of product code 

eligibility and the conditions of 

participation in the program will require 

submission of individual 30-day or 5- 

day malfunction reports in 

circumstances where such reports are 

necessary to protect public health. 

VIII. Analysis of 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. 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40985 

IX. Paperwork Reduction Act of 1995 

The Voluntary Malfunction Summary 

Reporting Program described in this 

Notice contains information collection 

provisions that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). 

These provisions have been approved 

under OMB control number 0910–0437. 

This document also refers to 

previously approved collections of 

information. These collections of 

information are subject to review by the 

OMB under the PRA (44 U.S.C. 3501– 

3520). The collections of information in 

part 4, subpart B, regarding 

postmarketing safety reporting for 

combination products have been 

approved under OMB control number 

0910–0834; the collections of 

information in part 803, regarding 

medical device reporting, have been 

approved under OMB control number 

0910–0437; the collections of 

information in 806, regarding 

corrections and removals, have been 

approved under OMB control number 

0910–0359; the collections of 

information in 21 CFR part 807, subpart 

E, regarding premarket notification, 

have been approved under OMB control 

number 0910–0120; the collections of 

information in 21 CFR part 814, 

subparts A through E, regarding 

premarket approval, have been 

approved under OMB control number 

0910–0231; the collections of 

information in 21 CFR part 810, 

regarding medical device recall 

authority, have been approved under 

OMB control number 0910–0432; the 

collections of information in part 820, 

regarding quality system regulations, 

have been approved under OMB control 

number 0910–0073; the collections of 

information in 21 CFR parts 1002 

through 1050, regarding radiological 

health, have been approved under OMB 

control number 0910–0025; the 

collections of information regarding the 

MedWatch: The Food and Drug 

Administration Medical Products 

Reporting Program have been approved 

under OMB control number 0910–0291; 

and the collections of information 

regarding the Adverse Event Program for 

Medical Devices (Medical Product 

Safety Network (MedSun)) have been 

approved under OMB control number 

0910–0471. 

X. References 

The following references are on 

display in the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852 and are available 

for viewing by interested persons 

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

through Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. Medical Device User Fee Agreement IV 

Commitment Letter, available at https:// 

www.fda.gov/downloads/ForIndustry/ 

UserFees/MedicalDeviceUserFee/ 

UCM535548.pdf. 

2. Food and Drug Administration, ‘‘Medical 

Device Reporting—Alternative Summary 

Reporting (ASR) Program; Guidance for 

Industry,’’ (October 19, 2000); available 

at https://www.fda.gov/downloads/ 

MedicalDevices/DeviceRegulation

andGuidance/GuidanceDocuments/ 

ucm072102.pdf. 

3. Food and Drug Administration, ‘‘Medical 

Device Reporting for Manufacturers; 

Guidance for Industry and Food and 

Drug Administration Staff,’’ (November 

8, 2016); available at https://

www.fda.gov/downloads/ 

medicaldevices/deviceregulationand

guidance/guidancedocuments/ 

ucm359566.pdf. 

4. Food and Drug Administration, ‘‘Center for 

Devices and Radiological Health Appeals 

Processes; Guidance for Industry and 

Food and Drug Administration Staff,’’ 

(May 17, 2013); available at https://

www.fda.gov/downloads/ 

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/ 

UCM284670.pdf. 

5. Food and Drug Administration, 

‘‘International Medical Device Regulators 

Forum,’’ available at https://

www.fda.gov/MedicalDevices/ 

InternationalPrograms/IMDRF/ 

default.htm. 

6. Appendix A, ‘‘Case Examples of Summary 

Malfunction Reporting,’’ available in 

Docket No. FDA–2017–N–6730. 

7. Food and Drug Administration, 

‘‘Postmarketing Safety Reporting for 

Combination Products; Draft Guidance 

for Industry and Food and Drug 

Administration Staff,’’ (March 2018); 

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

downloads/RegulatoryInformation/ 

Guidances/UCM601454.pdf. 

8. Food and Drug Administration, 

‘‘Compliance Policy for Combination 

Product Postmarketing Safety Reporting, 

Immediately in Effect Guidance for 

Industry and Food and Drug 

Administration Staff,’’ available at 

https://www.fda.gov/Regulatory

Information/Guidances/ucm601456.htm. 

9. Food and Drug Administration, Form FDA 

3500A, available at https://www.fda.gov/ 

downloads/aboutfda/reportsmanuals

forms/forms/ucm048334.pdf. 5. 

10. Electronic Medical Device Reporting 

(eMDR) (manufacturers may obtain 

information on how to prepare and 

submit reports in an electronic format 

that FDA can process, review, and 

archive), available at: https://

www.fda.gov/ForIndustry/ 

FDAeSubmitter/ucm107903.htm. 

Dated: August 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17770 Filed 8–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2018–0775] 

Drawbridge Operation Regulation; 

Columbia River, Portland, OR and 

Vancouver, WA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of deviation from 

drawbridge regulation. 

SUMMARY: The Coast Guard has issued a 

temporary deviation from the operating 

schedule that governs the Interstate 5 (I– 

5) Bridges across the Columbia River, 

mile 106.5, between Portland, Oregon, 

and Vancouver, Washington. The 

deviation is necessary to facilitate the 

presence of participants in the Hands 

Across the Bridge Project. This 

deviation allows the bridges to remain 

in the closed-to-navigation position 

during the event. 

DATES: This deviation is effective from 

11 a.m. to 2 p.m. on September 3, 2018. 

ADDRESSES: The docket for this 

deviation, USCG–2018–0775 is available 

at http://www.regulations.gov. Type the 

docket number in the ‘‘SEARCH’’ box 

and click ‘‘SEARCH.’’ Click on Open 

Docket Folder on the line associated 

with this deviation. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

deviation, call or email Mr. Steven 

Fischer, Bridge Administrator, 

Thirteenth Coast Guard District; 

telephone 206–220–7282, email d13-pfd13bridges@uscg.mil. 

SUPPLEMENTARY INFORMATION: Oregon 

Department of Transportation (bridge 

owner) requested a temporary deviation 

from the operating schedule for the I–5 

Bridges, mile 106.5, across the Columbia 

River between Vancouver, WA, and 

Portland, OR, to facilitate safe passage of 

participants in the Hands Across the 

Bridge Project. The I–5 Bridges provides 

three designated navigation channels 

with vertical clearances ranging from 39 

to 72 feet above Columbia River Datum 

0.0 while the lift spans are in the closedto-navigation position. The normal 

operating schedule for the I–5 Bridges is 

33 CFR 117.869. The subject bridges 

need not open to marine vessels during 


daltland on DSKBBV9HB2PROD with RULES