[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)]
[Notices]
[Pages 51820-51822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21036]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0110]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device 
Reporting: Manufacturer, Importer, User Facility, and Distributor 
Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 25, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0437. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device Reporting: Manufacturer, Importer, User Facility, and 
Distributor Reporting (21 CFR Part 803)--(OMB Control Number 0910-
0437)--Revision

    Section 519(a)(1) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act)

[[Page 51821]]

(21 U.S.C. 360i(a)(1)) requires every manufacturer or importer to 
report whenever the manufacturer or importer receives or otherwise 
becomes aware of information that reasonably suggests that one of its 
marketed devices may have caused or contributed to a death or serious 
injury or has malfunctioned and that such device or a similar device 
marketed by the manufacturer or importer would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
recur.
    Section 519(b)(1)(A) of the FD&C Act requires whenever a device 
user facility receives or otherwise becomes aware of information that 
reasonably suggests that a device has or may have caused or contributed 
to the death or serious illness, of a patient of the facility, the 
facility shall, as soon as practicable but not later than 10 working 
days after becoming aware of the information, report the information to 
the Secretary of HHS and, if the identity of the manufacturer is known, 
to the manufacturer of the device.
    Section 519(b)(1)(B) of the FD&C Act requires whenever a device 
user facility receives or otherwise becomes aware of information that 
reasonably suggests that a device has or may have caused or contributed 
to the serious illness of, or serious injury to, a patient of the 
facility, shall, as soon as practicable but not later than 10 working 
days after becoming aware of the information, report the information to 
the manufacturer of the device or to the Secretary of HHS if the 
identity of the manufacturer is not known.
    Complete, accurate, and timely adverse event information is 
necessary for the identification of emerging device problems. 
Information from these reports will be used to evaluate risks 
associated with medical devices which will enable FDA to take 
appropriate regulatory measures in protection of the public health 
under section 519 of the FD&C Act. Thus FDA is requesting approval for 
these information collection requirements which are being implemented 
under part 803 (21 CFR part 803).
    Respondents to this collection of information are businesses or 
other for-profit and nonprofit organizations including user facilities, 
manufacturers, and importers of medical devices.
    Part 803 requires user facilities to report to the device 
manufacturer and to FDA in case of a death, incidents where a medical 
device caused or contributed to a death or serious injury. 
Additionally, user facilities are required to annually submit the 
number and summary of adverse events reported during the calendar year 
using Form FDA 3419. Manufacturers of medical devices are required to 
report to FDA when they become aware of information indicating that one 
of their devices may have caused or contributed to death or serious 
injury or has malfunctioned in such a way, that should the malfunction 
recur, it would be likely to cause or contribute to a death or serious 
injury. Device importers report deaths and serious injuries to the 
manufacturers and FDA. Importers report malfunctions only to the 
manufacturers, unless they are unknown, then the reports are sent to 
FDA.
    The number of respondents for each Code of Federal Regulations 
(CFR) section in table 1 is based upon the number of respondents 
entered into FDA's internal databases. FDA estimates, based on its 
experience and interaction with the medical device community, that all 
reporting CFR sections are expected to take 1 hour to complete, with 
the exception of Sec.  803.19. Section 803.19 is expected to take 
approximately 3 hours to complete, but is only required for reporting 
the summarized data quarterly to FDA. By summarizing events, the total 
time used to report for this section is reduced because the respondents 
do not submit a full report for each event they report in a quarterly 
summary report.
    The Agency believes that the majority of manufacturers, user 
facilities, and importers have already established written procedures 
to document complaints and information to meet the medical device 
reporting (MDR) requirements as part of their internal quality control 
system. There are an estimated 30,000 medical device distributors. 
Although they do not submit MDR reports, they must maintain records of 
complaints under Sec.  803.18(d).
    The Agency has estimated that on average 220 user facilities, 
importers, and manufacturers would annually be required to establish 
new procedures, or revise existing procedures, in order to comply with 
this provision.
    Therefore, FDA estimates the one-time burden to respondents for 
establishing or revising procedures under Sec.  803.17 to be 6,006 
hours (1,820 respondents x 3.3 hours). For those entities, a one-time 
burden of 3.3 hours is estimated for establishing written MDR 
procedures. The remaining manufacturers, user facilities, and 
importers, not required to revise their written procedures to comply 
with this provision, are excluded from the burden because the 
recordkeeping activities needed to comply with this provision are 
considered ``usual and customary'' under 5 CFR 1320.3(b)(2).
    Under Sec.  803.18, 1,820 respondents represent distributors, 
importers, and other respondents to this information collection. FDA 
estimates that it should take them approximately 1.5 hours to complete 
the recordkeeping requirement for this section. Total hours for this 
section equal 2,730 hours.

Reporting Requirements

    Part 803 requires user facilities to report incidents where a 
medical device caused or contributed a death or serious injury to the 
device manufacturer and to FDA in the case of a death. Manufacturers of 
medical devices are required to report to FDA when they become aware of 
information indicating that one of their devices may have caused or 
contributed to death or serious injury or has malfunctioned in such a 
way that, should the malfunction recur, it would be likely to cause or 
contribute to a death or serious injury. Device importers report deaths 
and serious injuries to the manufacturers and FDA. Importers report 
malfunctions only to the manufacturers (see third-party disclosure 
burden table), unless the manufacturers are unknown, then the reports 
are sent to FDA.
    FDA estimates are based on our experience and interaction with the 
medical device community and burden analysis from the rulemaking. 
Section 803.19 is expected to take approximately 1 hour to complete, 
but is only required to report the summarized data quarterly to FDA. By 
summarizing events, the total time used to report for this section is 
reduced because the respondents do not submit a full report for each 
event they report in a quarterly summary report.

Recordkeeping Requirements

    The Agency believes that the majority of manufacturers, user 
facilities, and importers have already established written procedures 
to document complaints and information to meet the MDR requirements as 
part of their internal quality control system. The Agency has estimated 
that on average, 1,820 user facilities, importers, and manufacturers 
would annually be required, under Sec.  803.17, to establish new 
procedures, or revise existing procedures, in order to comply with this 
provision. We estimate that it will take each respondent 3.3 hours 
annually to establish new procedures, or revise existing procedures. We 
estimate that it will take each respondent 1.5 hours annually to 
maintain the records.

Third-Party Disclosure Burden

    Under Sec. Sec.  803.40 and 803.42, device importers report deaths 
and serious

[[Page 51822]]

injuries to the manufacturers and FDA. Importers report malfunctions 
only to the manufacturers, unless they are unknown, then the reports 
are sent to FDA. We estimate that it will take respondents 0.35 hours 
annually to report the information.
    In the Federal Register of May 07, 2015 (80 FR 26278), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received. However, since 
the 60-day notice, we have updated the burden estimates to reflect 
revisions made by the final rule, ``Medical Device Reporting: 
Electronic Submission Requirements,'' which became effective August 14, 
2015.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
                     21 CFR Section                        FDA Form No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
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Exemptions--803.19......................................  ..............              56               4             224               1             224
User Facility Reporting--803.30 and 803.32..............  ..............             520               7           3,640            0.35           1,274
User Facility Annual Reporting--803.33..................            3419             520               1             520               1             520
Importer Reporting, Death and Serious Injury--803.40 and  ..............               1               1               1               1               1
 803.42.................................................
Manufacturer Reporting--803.50, through 803.53..........  ..............           1,240             204         252,960            0.10          25,296
Supplemental Reports--803.56............................  ..............           1,050              94          98,700            0.10           9,870
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    Total...............................................  ..............  ..............  ..............  ..............  ..............          37,185
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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MDR Procedures--803.17..........           1,820               1           1,820             3.3           6,006
MDR Files--803.18...............           1,820               1           1,820             1.5           2,730
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    Total.......................  ..............  ..............  ..............  ..............          47,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                           21 CFR Section                               Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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Importer Reporting, Malfunctions--803.40 and 803.42................              60               25            1,500             0.35              525
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: August 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21036 Filed 8-25-15; 8:45 am]
BILLING CODE 4164-01-P