
[Federal Register Volume 77, Number 110 (Thursday, June 7, 2012)]
[Notices]
[Pages 33746-33748]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13832]


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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 July 9, 
2012.

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 oira_submission@omb.eop.gov. 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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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)--
Extension

    Section 519(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360i(a)(1)) requires every manufacturer or importer to 
report ``whenever the manufacturer or importer receives or otherwise 
becomes aware of information that reasonably suggests that one of its 
marketed devices: (A) May have caused or contributed to a death or 
serious injury, or (B) has malfunctioned and that such device or a 
similar device marketed by the manufacturer or importer would be likely 
to cause or contribute to a death or serious injury if the malfunction 
were to recur.''
    Section 519(b)(1)(A) of the 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 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: (i) Information 
that reasonably suggests that a device has or may have caused or 
contributed to the serious illness of, or serious injury to, a patient 
of the facility * * *, shall, as soon as practicable but not later than 
10 working days after becoming aware of the information, report the 
information to the manufacturer of the device or to the Secretary if 
the identity of the manufacturer is not known.''
    Complete, accurate, and timely adverse event information is 
necessary for the identification of emerging device problems. 
Information from these

[[Page 33747]]

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 advents 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 CFR section in table 1 of this 
document 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 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 2,200 
hours (220 respondents x 10 hours). For those entities, a one-time 
burden of 10 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, 30,000 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 45,000 hours.
    In the Federal Register of February 14, 2012 (77 FR 8260), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    Subsequent to publication of the 60-day notice, FDA performed an 
additional inspection of the data and consulted with the MDR program 
staff. Per this extra review, FDA has updated the estimated burden 
hours to more accurately reflect the burden.

Reporting Requirements

    21 CFR 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, 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 21 CFR 803.19. Section 
803.19 is expected to take approximately 3 hours 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. There are an estimated 
30,000 medical device distributors. Although they do not submit MDR 
reports, they must maintain records of complaints under 21 CFR 
803.18(d). We estimate that it will take each respondent 1.5 hours 
annually to maintain the records.
    The agency has estimated that on average, 220 user facilities, 
importers, and manufacturers would annually be required, under 21 CFR 
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 10 hours annually to establish new procedures, or revise 
existing procedures.

Third-Party Disclosure Burden

    Under 21 CFR 803.40 and 803.42, 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. We estimate that it will take respondents 
1 hour annually to report the information.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 33748]]



                                                       Table 1--Estimated Annual Reporting Burden
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                                                                                              Annual
                       CFR Section                         FDA Form No.      Number of     frequency of    Total annual      Hours per      Total hours
                                                                            respondents      response        responses       response
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Exemptions--803.19......................................  ..............              57               4             228               3             684
User Facility Reporting--803.30 and 803.32..............  ..............             544               9           4,896               1           4,896
User Facility Annual Reporting--803.33..................   FDA Form 3419             195               1             195               1             195
Importer Reporting, Death and Serious Injury--803.40 and  ..............               1               1               1               1               1
 803.42.................................................
Manufacturer Reporting--803.50, through 803.53..........  ..............           1,239             243         301,077               1         301,077
Supplemental Reports--803.56............................  ..............             124             302          37,448               1          37,448
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    Total...............................................  ..............  ..............  ..............  ..............  ..............         344,301
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                                 Table 2--Estimated Annual Recordkeeping Burden
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                                                      Annual
         21 CFR Section              Number of     frequency of    Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records      recordkeeper
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MDR Procedures--803.17..........             220               1             220              10           2,200
MDR Files--803.18...............          30,000               1          30,000             1.5          45,000
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    Total.......................  ..............  ..............  ..............  ..............          47,200
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                                                 Table 3--Estimated Annual Third-Party Disclosure Burden
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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................               1               25               25                1               25
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    Dated: June 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13832 Filed 6-6-12; 8:45 am]
BILLING CODE 4160-01-P


