Document ID: FDA-2012-N-0110-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Reporting: Manufacturer, Importer,
User Facility, and Distributor Reporting
Posted Date: 2015-05-07T04:00Z

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26278-26280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10995]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on medical device reporting 
(MDR); manufacturer, importer, user facility, and distributor 
reporting.

DATES: Submit either electronic or written comments on the collection 
of information by July 6, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use

[[Page 26279]]

of automated collection techniques, when appropriate, and other forms 
of information technology.

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 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.
    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 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.

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, 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 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 Sec.  
803.18(d). We estimate that it will take

[[Page 26280]]

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 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 10 hours annually to establish new procedures, or revise 
existing procedures.

Third-Party Disclosure Burden

    Under Sec. Sec.  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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of                        Average
                       CFR section                         FDA form No.      Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       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..................            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
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............         344,301
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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
         21 CFR section             Number of      records per    Total annual   Average  burden    Total hours
                                  recordkeepers   recordkeeper       records       per  record
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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
                                --------------------------------------------------------------------------------
    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................               1               25               25                1               25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: May 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10995 Filed 5-6-15; 8:45 am]
 BILLING CODE 4164-01-P