Document ID: FDA-2014-D-1837-0001
Agency: fda
Document Type: Notice
Title: Transfer of a Premarket Notification 510k Clearance Questions and Answers Draft Guidance for Industry and Food and Drug Administration Staff Availability
Posted Date: 2014-12-22T05:00Z

[Federal Register Volume 79, Number 245 (Monday, December 22, 2014)]
[Notices]
[Pages 76331-76333]
From the Federal Register Online via the Government Printing 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Questions and Answers; Draft Guidance for Industry and Food and Drug 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availability of the draft guidance entitled ``Transfer of a Premarket 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of the draft guidance is to provide information on how to notify FDA of 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 This draft 
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 23, 2015.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requests for a single hard copy of the draft guidance document entitled 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 CDRH-Guidance@fda.hhs.gov 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)
                                 -------------------------------------------------------------------------------
    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

[[Page 76333]]

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]
BILLING CODE 4164-01-P