[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50010-50013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20309]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2918]


Pilot Program for Medical Device Reporting on Malfunctions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is soliciting 
nominations for participation in a pilot program for the submission of 
medical device reports for malfunctions of class I devices and certain 
class II devices in summary format on a quarterly basis. Under the 
Medical Device Reporting on Malfunctions pilot program, FDA intends to 
work with manufacturers to identify candidates for the pilot program 
and intends to continue to accept nominations until candidates for the 
pilot program have been selected.

DATES: FDA will begin accepting nominations for participation in the 
voluntary pilot program on September 1, 2015, and intends to continue 
to accept nominations until candidates for the pilot program have been 
selected. See section II for instructions on how to participate in the 
voluntary pilot program.

FOR FURTHER INFORMATION CONTACT: William C. Maloney, Center for Devices 
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3236, 
Silver Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration Amendments Act of 2007 (FDAAA) 
(Pub. L. 110-85), amended section 519(a) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(a)), relating to the 
reporting of device malfunctions to FDA under part 803 (21 CFR part 
803). Specifically, FDAAA amended the FD&C Act to require that medical 
device reports of malfunctions for class I devices and those class II 
devices that are not permanently implantable, life supporting, or life 
sustaining--with the exception of any type of class I or II device 
which 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 
(section 519(a)(1)(B)(ii) of the FD&C Act).\1\ The criteria must 
require the reports to be in summary form and made on a quarterly basis 
(section 519(a)(1)(B)(ii) of the FD&C Act).
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    \1\ In light of section 1003(d) of the FD&C Act (21 U.S.C. 
393(d)) and the Secretary of Health and Human Services' (the 
Secretary's) delegation to the Commissioner of Food and Drugs, 
statutory references to ``the Secretary'' have been changed to 
``FDA'' or the ``Agency'' in this document.
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    FDA is considering the development of malfunction reporting 
criteria for devices subject to section 519(a)(1)(B)(ii) of the FD&C 
Act. In the interim, FDA clarified that all manufacturers of class I 
devices and those class II devices that are not permanently 
implantable, life supporting, or life sustaining, must continue to 
report in full compliance with part 803 (76 FR 12743 at 12744, March 8, 
2011).
    The malfunction reporting requirements for class III devices and 
those class II devices that are permanently implantable, life 
supporting, or life sustaining were not altered by FDAAA. Under the 
amended section 519(a) of the FD&C Act, device manufacturers are to 
continue to submit malfunction reports in accordance with part 803 for 
all class III devices and for those class II devices that are 
permanently implantable, life supporting, or life sustaining, unless 
FDA grants an exemption or variance from, or an alternative to, a 
requirement under such regulations under Sec.  803.19 (section 
519(a)(1)(B)(i) of the FD&C Act).
    In addition, under section 519(a) of the FD&C Act, as amended by 
FDAAA, there is no change to the obligation for an importer to submit 
malfunction reports to the manufacturer in accordance with part 803 for 
devices that it imports into the United States (section 
519(a)(1)(B)(iii) of the FD&C Act).
    FDA intends to use the information learned and experiences gained 
from the pilot program to develop the malfunction reporting criteria 
for devices subject to section 519(a)(1)(B)(ii) of the FD&C Act.

II. Pilot Program for Medical Device Reporting (MDR) on Malfunctions

    FDA has developed this pilot program for manufacturers interested 
in submitting malfunction reports for certain devices in a summary 
format on a quarterly basis. This notice provides:

[[Page 50011]]

(1) The guiding principles underlying the pilot program, (2) the 
conditions for participation in the pilot program, (3) a description of 
the pilot program, (4) the eligibility criteria for the pilot program, 
(5) the procedures that FDA intends to follow in the pilot program, (6) 
the manufacturer notification process, (7) FDA's review process for the 
summary reports, (8) the duration of the pilot program, and (9) FDA's 
evaluation process for the pilot program.

A. Guiding Principles

    The following basic principles underlie the Medical Device 
Reporting on Malfunctions pilot program described in this notice. FDA 
intends for these principles to create a common understanding between 
the manufacturer and FDA about the goals and parameters of this pilot 
program.
    1. FDA is exploring a possible approach to summary reporting of 
device malfunctions on a quarterly basis under the pilot program (as 
illustrated in the case examples in this notice in section II.C. 
Description of the Program) that would allow FDA to collect sufficient 
detail to effectively monitor the devices subject to section 
519(a)(1)(B)(ii) of the FD&C Act and protect the public health.
    2. The data received in this pilot should contain details 
sufficient to understand the device-related malfunctions. A narrative 
text should be provided to include a summary of the malfunction events, 
the results of the manufacturer's investigation of the reported 
malfunctions, including the type of any remedial action taken or an 
explanation of why remedial action was not taken, and any additional 
information that would be helpful to understand how the manufacturer 
addressed the malfunctions summarized in the report.
    3. As the summary information collected under this pilot represents 
a subset of the detailed information collected under Sec.  803.52, FDA 
intends to use the existing electronic Medical Device Reporting (eMDR) 
infrastructure for the summary reports.
    4. All summary MDR reports \2\ will appear in the Manufacturer and 
User Facility Device Experience (MAUDE) database, which is publically 
available.
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    \2\ Any information in the report that is protected from public 
disclosure under the Freedom of Information Act (FOIA) will be 
redacted prior to the release of the report.
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B. Conditions

    1. Under Sec.  803.19, manufacturers who are accepted into the 
program will be granted an exemption or variance from, or alternative 
to, the reporting requirements under Sec. Sec.  803.50(a) and 803.52 
for those malfunction events associated with the devices selected for 
the pilot. Other reportable events involving the devices selected for 
the pilot must be reported to FDA within the mandatory 30-calendar day 
timeframe on Form FDA 3500A, as required by Sec. Sec.  803.50(a) and 
803.52, or within the 5-work day timeframe as required by Sec.  803.53. 
Additional information and instructions will be provided to 
manufacturers accepted into the pilot.
    2. A candidate is not precluded from withdrawing from the pilot 
program at any time and returning to the individual reporting 
requirements of Sec. Sec.  803.50(a) and 803.52.
    3. Due to FDA resource issues, FDA intends to limit the pilot 
program to no more than nine (9) candidates.
    4. At its discretion, FDA may withdraw a manufacturer from the 
pilot program, for reasons including, but not limited to, any 
violations of the FD&C Act, failure to follow the instructions of the 
pilot program, or if FDA obtains information after the manufacturer is 
accepted to the pilot program that the manufacturer is not an 
appropriate candidate for the program as described in this notice in 
section II.D. Appropriate Candidates. Withdrawal from the pilot program 
will result in a return to the individual reporting requirements of 
Sec. Sec.  803.50(a) and 803.52.
    5. At its discretion, FDA may modify specific details regarding the 
pilot if needed. Any such changes will be communicated directly to the 
candidates of the pilot program.

C. Description of the Program

    Candidates of the pilot program will submit Form FDA 3500A reports 
in electronic reporting format on a quarterly basis. For purposes of 
the pilot, ``quarterly basis'' is defined as a three (3) month period. 
Each submission should represent a summary of malfunction events 
received for a unique device problem code or set of codes within the 
quarterly timeframe, and for a particular device model number and/or 
catalog number. Device malfunctions that are summarized in one report 
should not be duplicated in any other submissions within the same 
quarterly timeframe.
    Summary reports should include the following information collected 
on Form FDA 3500A in electronic format:
    SECTION B.5: Describe Event or Problem--The device event narrative 
should include a description of the nature of the events (being as 
specific as possible); and if available, a range of patient age and 
weight, and a breakdown of patient gender. The first sentence of the 
device event narrative should include the following sentence:
    ``This report summarizes  XXX  malfunction events'' 
where XXX is replaced by the number of malfunction events being 
summarized.
    SECTION D.2 and D.2.b: Common Device Name and Procode--Enter the 
common name of the device and the product code.
    SECTION D.3: Manufacturer Name, City and State--Enter the 
manufacturer name, city and state where the manufacturer is located.
    SECTION D.4: Device Identification--Enter the model or catalog 
number for the device being summarized in the MDR report.
    SECTION G.1: Contact Office (and Manufacturing Site for Devices)--
Enter the name and address of the manufacturer reporting site [contact 
office], including contact name for the report submitted. Enter the 
name and address of the manufacturing site for the device, if different 
from the contact office.
    SECTION G.2: Phone Number--Enter the phone number for the contact 
office.
    SECTION H.1: Type of Reportable Event--Check ``Malfunction'' in 
this box.
    SECTION H.6: Event Problem and Evaluation Codes--Enter the device 
problem code(s), including any codes received from a user facility or 
importer report provided in Section F.10 of Form FDA 3500A. Enter 
``9999'' as the first device problem code to identify the report as a 
summary malfunction report. Enter the evaluation code(s) for the 
categories of method, results, and conclusions. Enter a conclusion 
code(s) even if the device was not evaluated.
    SECTION H.10: Additional Manufacturer Narrative--Provide a summary 
of the results of your investigation of the reported malfunctions, 
including the type of any remedial action taken or an explanation of 
why remedial action was not taken, and any additional information that 
would be helpful to understand how you addressed the malfunction events 
summarized in the report. Also enter a breakdown of the malfunction 
events summarized in the report, including the number of devices that 
were returned to you; the number of devices that were labeled for 
single use (if any); and the number of devices that were reprocessed 
and re-used (if any).

    Note: All reportable adverse events which result in a serious 
injury or death; and/or necessitate remedial action to prevent an 
unreasonable risk of substantial harm to the public health, are 
excluded from this pilot program. In addition, for reference here is 
the

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link to the on-line version of the Form FDA 3500A: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048334.pdf.

    Case Examples: The following examples are meant to illustrate the 
format for how malfunction reports submitted under this pilot will be 
captured. All of these examples are for class I devices and those class 
II devices that are not permanently implantable, life supporting, or 
life sustaining. These examples do not address interpretation of these 
reportable events.
    Case Scenario #1: Multiple malfunction reports for the same device 
problem. A manufacturer receives 50 similar reports within the 
quarterly timeframe indicating that model XYZ pump experienced an air 
detected set alarm, which interrupted delivery. The alarms may have 
been a false alarm. These events were received from various sources. Of 
the 50 adverse events, 46 did not involve patients, and 4 involved 
patients with no reported injuries or deaths. None of these events 
necessitate remedial action to prevent an unreasonable risk of 
substantial harm to the public health. The XYZ pumps were recently 
retrofitted with a new user interface software model V.2.04.12.
    Report for Case #1: A single summary MDR report is to be submitted 
to FDA through eMDR:
     B.5: This report summarizes  50  malfunction 
events. A review of the events indicated that model XYZ pump 
experienced an air detected set alarm, which interrupted delivery. The 
alarms may have been a false alarm. These reports were received from 
various sources. Of the 50 events, 46 did not involve patients, and 4 
involved patients with no patient consequences. The four patients 
ranged from 25-32 years of age and 130-250 lbs. Of the reported 
patients, one was male and three were female. The XYZ pumps were 
recently retrofitted with a new user interface software model 
V.2.04.12.
     D.2: Infusion Pump
     D.2.b: FRN
     D.3: ABC Company, 123 Baker Street, Anywhere, MD, USA
     D.4: Model XYZ
     G.1: Mr. X, ABC company, 123 Baker Street, Anywhere, MD, 
USA
     G.2: 301-555-0001
     H.1: Malfunction
     H.6: Device Codes: 9999 (Summary Malfunction); 1008 (Air 
Leak)
     H.6: Manufacturer Method Codes: 10 (Actual Device 
Evaluated); 38 (Visual Inspection)
     H.6: Manufacturer Results Code: 549 (Air pump assembly)
     H.6: Manufacturer Evaluation Conclusion Codes: 52 (Device 
was out of calibration)
     H.10: For 40 of the 50 reported events, the devices were 
returned to ABC, and their operating condition was confirmed by 
service. The cause of the malfunction was determined to be a faulty 
pump head module. To correct the condition, the pump head modules were 
replaced.
    Case Scenario #2: Multiple malfunction reports that have two device 
problems: A manufacturer receives 100 malfunction reports within the 
quarterly timeframe that include two types of device malfunctions that 
are related to a specific model (XYZ, Version 2) of a powered AC bed: 
(1) 75 events involve a broken weld near where the motor attaches; and 
(2) 55 events involve a screw that attaches the bed rail to the 
mounting bracket on the bed, which snapped. Some of the events involve 
both types of device malfunctions. None of the events involve patients. 
None of the events necessitate remedial action to prevent an 
unreasonable risk of substantial harm to the public health.
    Reports for Case #2: Under this pilot, a unique device problem code 
or set of codes for a particular device model number and/or catalog 
number that are summarized in one report should not be duplicated in 
any other submissions within the same quarterly timeframe. As a result, 
there are three categories of reports for this scenario--(1) 45 events 
that involve broken welds only; (2) 25 events that involve broken 
screws only; and (3) 30 events that involve both broken welds and 
broken screws. Therefore, three summary reports will need to be 
submitted to FDA through eMDR.
    Report #1:
     B.5: This report summarizes  45  malfunction 
events. A review of the events indicated that model XYZ experienced 
broken welds near where the motor attaches to the powered AC beds. No 
patients were involved.
     D.2: AC Powered Beds
     D.2.b: FNL
     D.3: ABC company, 123 Baker Street, Anywhere, MD, USA
     D.4: Model XYZ
     G.1: Mr. X, ABC Company, 123 Baker Street, Anywhere, MD, 
USA
     G.2: 301-555-0001
     H.1: Malfunction
     H.6: Device Codes: 9999 (Summary Malfunction); 1069 
(Break); 3195 (Weld)
     H.6: Manufacturer Method Codes: 10 (Actual Device 
Evaluated); 38 (Visual Inspection)
     H.6: Manufacturer Results Code: 170 (Manufacturing process 
problem)
     H.6: Manufacturer Evaluation Conclusion Codes: 12 (Design 
deficiency)
     H.10: To correct the condition, the beds were taken out of 
service.
    Report #2:
     B.5: This report summarizes  25  malfunction 
events. A review of the events indicated that a screw that attaches the 
bed rail to the mounting bracket on the bed is snapping on model XYZ. 
No patients were involved.
     D.2: AC Powered Beds
     D.2.b: FNL
     D.3: ABC company, 123 Baker Street, Anywhere, MD, USA
     D.4: Model XYZ
     G.1: Mr. X, ABC Company, 123 Baker Street, Anywhere, MD, 
USA
     G.2: 301-555-0001
     H.1: Malfunction
     H.6: Device Codes: 9999 (Summary Malfunction); 1069 
(Break); 568 (Screw)
     H.6: Manufacturer Method Codes: 10 (Actual Device 
Evaluated); 38 (Visual Inspection)
     H.6: Manufacturer Results Code: 170 (Manufacturing process 
problem)
     H.6: Manufacturer Evaluation Conclusion Codes: 12 (Design 
deficiency)
     H.10: To correct the condition, the beds were taken out of 
service temporarily. A technician was dispatched to replace the screw. 
Load testing was applied to verify bed rail performance.
    Report #3:
     B.5: This report summarizes  30  malfunction 
events. A review of the events indicated that a screw that attaches the 
bed rail to the mounting bracket on the AC powered bed failed causing 
the bed rail to detach and collide with the beam near where the motor 
attaches. The force of impact caused a broken weld to form near the 
motor attachment on the AC powered bed. No patients were involved.
     D.2: AC Powered Beds
     D.2.b: FNL
     D.3: ABC Company, 123 Baker Street, Anywhere, MD, USA
     D.4: Model XYZ
     G.1: Mr. X., ABC Company, 123 Baker Street, Anywhere, MD, 
USA
     G.2: 301-555-0001
     H.1: Malfunction
     H.6: Device Codes: 9999 (Summary Malfunction); 1069 
(Break); 3195 (Screw); 568 (Weld)
     H.6: Manufacturer Method Codes: 10 (Actual Device 
Evaluated); 38 (Visual Inspection)
     H.6: Manufacturer Results Code: 170 (Manufacturing process 
problem)

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     H.6: Manufacturer Evaluation Conclusion Codes: 12 (Design 
deficiency)
     H.10: To correct the condition, the beds were taken out of 
service. Technicians have examined the beds and have opened up a 
Corrective and Preventive Action (CAPA) to address the design issue.

D. Appropriate Candidates

    Appropriate candidates for the pilot program are manufacturers who:
    1. Are currently submitting reports to FDA using the paper Form FDA 
3500A or the electronic MDR (eMDR) format.
    2. Manufacture class I devices and/or those class II devices that 
are not permanently implantable, life supporting, or life sustaining.
    3. Currently use or are willing to use eMDR to submit summary 
malfunction reports to the FDA during the pilot period.
    4. Are in compliance with the Medical Device Reporting regulation 
in 21 CFR part 803.

E. Procedures

1. Nomination
    A manufacturer of class I devices and those class II devices that 
are not permanently implantable, life supporting, or life sustaining 
may nominate themselves for participation in the pilot program by 
submitting a nomination to [email protected]. FDA intends to 
acknowledge receipt of nominations via return email. The following 
information will assist FDA in processing and responding to 
nominations:
     Name of manufacturer
     Registration number
     Contact name, address, phone number, and email address
     Model or catalog number for the device(s) that you are 
requesting to include in the pilot, and
     Product classification code for the device(s) that you are 
requesting to include in the pilot. You may access the Product 
Classification Code database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
2. FDA Consideration
    Acceptance of nominations will start 2 weeks following the 
publication date of this Federal Register notice. Because only a 
limited number of candidates are needed, FDA will use its discretion in 
choosing candidates based on the eligibility criteria in this Federal 
Register notice in section II.D. Appropriate Candidates, the needs of 
the pilot to include a diversity of manufacturers with regard to device 
type (including in vitro diagnostic devices), and expected number of 
malfunction events. FDA may contact the manufacturer to request 
supplemental information if this information is needed in order to 
complete our review of the request. The manufacturer must provide the 
supplemental information within 15 days of FDA's request; otherwise, 
the Agency will consider the nomination withdrawn.

F. Manufacturer Notification

    FDA intends to notify manufacturers who are selected for this pilot 
program within 45 days from receiving their nomination or any 
supplemental information requested by FDA. Once FDA has selected the 
candidates for this pilot, FDA will notify subsequent applicants by 
email that the nomination period has closed.

G. FDA Review

    All reports received under the pilot program will be reviewed and 
processed in the same manner as individual medical device reports that 
are submitted under part 803. A version of the report releasable under 
FOIA will be accessible through the public MAUDE database.

H. Duration of the Pilot

    FDA intends for the pilot program to run for 2 calendar quarters 
for each candidate and will continue until the 2 calendar quarters have 
been completed for all candidates. At its discretion, FDA may terminate 
the pilot program before the close of this period, or FDA may extend 
the pilot program beyond the 2 calendar quarters. The decision to 
terminate or extend the pilot will be announced in the Federal 
Register.

I. Evaluation

    FDA intends to evaluate all information and feedback received from 
the candidates and to use the information and experiences gained from 
the pilot program to develop criteria for summary reporting on a 
quarterly basis for devices subject to section 519(a)(1)(B)(ii) of the 
FD&C Act.

III. Paper Reduction Act of 1995

    This notice refers to previously approved collections of 
information 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). The collections of information in 21 CFR part 803 have been 
approved under OMB control number 0910-0437; the collections of 
information in Form FDA 3500A have been approved under OMB control 
number 0910-0291.

    Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20309 Filed 8-17-15; 8:45 am]
 BILLING CODE 4164-01-P