[Federal Register Volume 79, Number 245 (Monday, December 22, 2014)]
[Notices]
[Pages 76331-76333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29832]
[[Page 76331]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1837]
Transfer of a Premarket Notification (510(k)) Clearance--
Questions and Answers; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Transfer of a Premarket
Notification (510(k)) Clearance--Questions and Answers.'' The purpose
of the draft guidance is to provide information on how to notify FDA of
the transfer of a premarket notification clearance from one holder to
another, and the procedures FDA and industry should use to ensure
public information in FDA's databases about the current 510(k) holder
for a specific device(s) is accurate and up-to-date. This draft
guidance is not final nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 23, 2015. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by February 20, 2015,
(see the ``Paperwork Reduction Act of 1995'' section of this document).
ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Transfer of a Premarket Notification (510(k)) Clearance--Questions
and Answers'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002 or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research (CBER), Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Marjorie Shulman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1536, Silver Spring, MD 20993-0002, 301-
796-6572 or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
I. Background
FDA is announcing the availability of the draft guidance entitled
``Transfer of a Premarket Notification (510(k)) Clearance--Questions
and Answers.'' This draft guidance provides information on how to
notify FDA of the transfer of a 510(k) clearance from one holder to
another, and the procedures FDA and industry should use to ensure
public information in FDA's databases about the current 510(k) holder
for a specific device(s) is accurate and up-to-date.
Previously, FDA's databases did not reflect changes in the 510(k)
holder that occurred after FDA's clearance of the 510(k). This was in
part because 510(k) holders were not required to list their devices by
510(k) number, which made it difficult for FDA to tie a particular
510(k) to its current holder. Lack of updated, accurate 510(k) holder
information created a number of challenges for FDA, for current 510(k)
holders, future 510(k) submitters, and other stakeholders.
The Food and Drug Administration Amendments Act of 2007 (FDAAA)
(Public Law 110-85) amended section 510 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) by requiring domestic and foreign device
establishments to begin submitting their registration and device
listing information to FDA by electronic means rather than on paper
forms,\1\ and also specified the timeframes within which establishments
are required to submit such information.\2\ In accordance with FDAAA,
the Agency launched FDA's Unified Registration and Listing System
(FURLS), an Internet-based registration and listing system.\3\
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\1\ See FD&C Act section 510(p) (21 U.S.C. 360(p)).
\2\ See FD&C Act sections 510(b)(2), (i), and (j) (21 U.S.C.
360(b)(2), (i), and (j)).
\3\ See 77 FR 45927 (August 2, 2012).
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Notification to FDA of a sale or other transfer of a 510(k)
clearance, whether or not the device is already on the market, is
accomplished by compliance with device listing requirements. As a
result of the launch of the FURLS Device Registration and Listing
Module (DRLM) and the changes to the registration and listing
regulations that became effective on October 1, 2012,\4\ the medical
device listing information provided to FDA changed. Owners and
operators of medical device establishments that market 510(k)-cleared
devices must now supply the FDA-assigned premarket submission number of
the cleared 510(k) when they list their devices in FURLS.\5\ This
listing allows FDA to easily identify the holder of each 510(k) based
on the records created by manufacturers, specification developers,
repackers/relabelers, single-use device reprocessors, or
remanufacturers in FURLS DRLM. Listing information is required to be
updated at least annually \6\ and there may only be one 510(k) holder
for a device at a time; \7\ therefore, this updated listing provides
FDA with current 510(k) holder information by 510(k) number.
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\4\ See id.
\5\ See 21 CFR 807.25(g)(4).
\6\ See FD&C Act section 510(j) (21 U.S.C. 360(j)) and 21 CFR
807.22.
\7\ See FD&C Act section 510(k) (21 U.S.C. 360(k)) and 21 CFR
807.81(a).
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II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on how to
notify FDA of the transfer of a 510(k) clearance and the procedures FDA
and industry should use to ensure public information in FDA's databases
about the current 510(k) holder for a specific device(s) is accurate
and up-to-date. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by
[[Page 76332]]
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Transfer of a Premarket Notification
(510(k)) Clearance--Questions and Answers,'' may send an email request
to [email protected] to receive an electronic copy of the
document. Please use the document number 1808 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 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 of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Transfer of a Premarket Notification (510(k)) Clearance--
Questions and Answers
This draft guidance is intended to provide information on how to
notify FDA of the transfer of a 510(k) clearance from one person to
another, and the procedures FDA and industry should use to ensure
public information in FDA's databases about the current 510(k) holder
for a specific device(s) is accurate and up-to-date. The proposed
information collection seeks to provide information in order to notify
FDA of the transfer of a premarket notification (510(k)) clearance.
Description of respondents: The respondents to this collection of
information are 510(k) holders and parties claiming to be 510(k)
holders. The Agency estimates the burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Guidance title: transfer of a Number of Average burden
premarket notification (510(k)) Number of responses per Total annual per response Total hours
clearance--questions and answers respondents respondent responses (in hours)
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Voluntary reporting of transfer 4,080 1 4,080 .25 1,020
of 510(k) Clearance on FDA's
Unified Registration and
Listing System (Outside of
Annual Listing Reporting
Requirement)...................
Submission of 510(k) transfer 2,033 1 2,033 4 8,132
documentation when more than
one party lists the same 510(k)
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Total....................... .............. .............. .............. .............. 9,152
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Currently, FDA estimates 78% of 510(k)s are listed outside of the
annual registration cycle based on numbers in the FURLS database from
fiscal year 2009 through fiscal year 2014. Fiscal year 2008 was left
out of this cohort as it was the first year that registrants were
required to report the 510(k) number on their listings and, therefore,
an unusually high number of listings were created. An average of 5,231
510(k)s have been listed in each year since 2008. Because listing
outside of the annual requirement is voluntary, FDA estimates that
annually 78% of 510(k)s will continue to be listed outside of the
annual requirement. FDA estimates that 4,080 510(k)s may be listed
outside of the annual registration cycle. FDA estimates that it will
take approximately 15 minutes for each listing, for a total reporting
burden of 1,020 hours.
FDA estimates it will have 2,033 instances of more than one party
claiming to be a 510(k) holder for a specific device as part of annual
registration and listing. The Agency reached this estimate by
identifying the number of unique 510(k) device listings entered in
FURLS between fiscal years 2009 and 2014 that conflict with a listing
already entered by another party (5,304), dividing that number by the
number of years (six), and multiplying by the average number of parties
claiming to be the 510(k) holder when there is a conflict in the
current FURLS database (2.3). The draft guidance identifies potential
documentation a party could submit to FDA to establish the transfer of
a 510(k) clearance. FDA estimates it will take a party approximately 4
hours to locate and submit information to establish the transfer of the
510(k) clearance, resulting in 8,132 burden hours for those 2,033
parties claiming to be 510(k) holders. FDA reached this estimate based
on its expectation of the amount of time it will take a party to locate
the information, to copy, and to submit a copy to FDA.
The burden estimate does not include the maintenance of records
used to document transferring a premarket notification (510(k))
clearance. Based on available information, FDA believes that the
maintenance of these records is a usual and customary part of normal
business activities. For example, in the ordinary course of business,
supporting documents should be kept to verify asset information for
calculating the annual depreciation or calculating gain or loss on sale
of an asset on a businesses' tax return. Therefore, this
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recordkeeping requirement creates no additional paperwork burden.
Before the proposed information collection provisions contained in
this draft guidance become effective, FDA will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the information collection provisions. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR part 807 (registration and listing) are approved under OMB
control number 0910-0625; collections of information in 21 CFR part 807
subpart E (premarket notification submission) have been approved under
OMB control number 0910-0120 and collections of information in 42 CFR
493.17 have been approved under OMB control number 0910-0607.
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: December 16, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29832 Filed 12-19-14; 8:45 am]
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