83 FR 49097 - The Special 510(k) Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 189 (September 28, 2018)

Page Range		49097-49099
FR Document		2018-21141

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``The Special 510(k) Program.'' FDA established the Special 510(k) Program to facilitate the submission, review, and clearance of changes to a manufacturer's own legally marketed predicate device. This draft guidance, when finalized, will provide the framework that FDA will use when considering whether a premarket notification (510(k)) is appropriate for review as a Special 510(k). This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 83 Issue 189 (Friday, September 28, 2018)

[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49097-49099]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3304]


The Special 510(k) Program; Draft Guidance for Industry and Food 
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft

[[Page 49098]]

guidance entitled ``The Special 510(k) Program.'' FDA established the 
Special 510(k) Program to facilitate the submission, review, and 
clearance of changes to a manufacturer's own legally marketed predicate 
device. This draft guidance, when finalized, will provide the framework 
that FDA will use when considering whether a premarket notification 
(510(k)) is appropriate for review as a Special 510(k). This draft 
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by November 27, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-3304 for ``The Special 510(k) Program.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``The Special 510(k) Program'' 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 the Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, 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.

FOR FURTHER INFORMATION CONTACT: Joshua Silverstein, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-
796-5155; Angela DeMarco, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
1611, Silver Spring, MD 20993-0002, 301-796-4471; 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    On March 20, 1998, FDA issued the guidance document entitled ``The 
New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial 
Equivalence in Premarket Notifications,'' which established the Special 
510(k) Program. By establishing the Special 510(k) Program, FDA sought 
to streamline review of 510(k) submissions by leveraging design control 
requirements. The Special 510(k) Program allows manufacturers who are 
intending to change their own legally marketed device to utilize risk 
analysis and verification and validation activities to facilitate 
submission, review, and clearance of the change. While FDA intends to 
review Special 510(k)s within 30 days, the Special 510(k) Program does 
not alter any statutory or regulatory requirements related to the 
premarket notification process under sections 510 and 513 of the FD&C 
Act (21 U.S.C. 360 and 360c) and 21 CFR part 807, subpart E.
    To improve the efficiency of 510(k) review, FDA believes that an 
update to the Special 510(k) Program both clarifies existing policy and 
expands on device changes appropriate for the Program. This draft 
guidance, when finalized, will explain the updated factors FDA intends 
to use when considering

[[Page 49099]]

whether a 510(k) is appropriate for review as a Special 510(k). In 
general, a change to an existing device may be appropriate for a 
Special 510(k) when: (1) The proposed change is made and submitted by 
the manufacturer authorized to market the existing device; (2) 
performance data are unnecessary, or if performance data are necessary, 
well-established methods are available to evaluate the change; and (3) 
all performance data necessary to support substantial equivalence can 
be reviewed in a summary or risk analysis format.
    When finalized, this guidance will supersede the Special 510(k) 
policy in the 1998 guidance entitled ``The New 510(k) Paradigm: 
Alternate Approaches to Demonstrating Substantial Equivalence in 
Premarket Notifications.''

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 current thinking of FDA on ``The Special 
510(k) Program.'' It does not establish any rights for any person and 
is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations. This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by 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. This 
guidance document is also available at https://www.regulations.gov or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``The Special 510(k) Program'' may send 
an email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 18008 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
the following FDA regulations have been approved by OMB as listed in 
the following table:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA                              OMB control
              form                        Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification.       0910-0120
801............................  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
------------------------------------------------------------------------


    Dated: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21141 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49097

II. Arguments Medicaid for procedures other than fraud, perjury, false statement,
Fleming submitted multiple those that he had performed, that he racketeering, blackmail, extortion,
documents in support of his arguments falsified clinical trial data, and that his falsification or destruction of records, or
that his guilty plea ‘‘does not state a actions ‘‘have the potential for causing interference with, obstruction of an
crime’’ and that he is ‘‘actually significant loss of public confidence in investigation into, or prosecution of, any
innocent.’’ However, section 306(l) of the healthcare system.’’ Fleming’s criminal offense and (2) based on the
the FD&C Act defines conviction as actions took place over a period of conviction and other information,
when a Federal or State court’s several months and demonstrated Fleming has demonstrated a pattern of
judgment of conviction or when a multiple instances of fraud. While conduct giving reason to believe that he
Federal or State court’s acceptance of a Fleming contends that he performed may violate requirements under the
guilty plea. In Fleming’s ‘‘Petition to safer imaging studies than those billed, FD&C Act relating to drug products.
Enter a Plea of Guilty,’’ he stated that he FDA must weigh this claim against the FDA considered the applicable factors
serious nature of the fraud he listed in section 306(c)(3) of the FD&C
understood the charges against him and
committed. Construing Fleming’s Act and determined that a debarment of
that he was voluntarily entering his
argument in a light most favorable to 10 years is appropriate.
guilty plea. The court entered a
him, whether he performed safer As a result of the foregoing findings,
judgment of conviction after accepting
imaging studies does not sufficiently Fleming is debarred for 10 years from
Fleming’s guilty plea. Federal court is
counter the very serious nature of providing services in any capacity to a
the proper venue for any challenge to
fraudulent conduct and is not enough to person with an approved or pending
Fleming’s guilty plea based on a claim
establish that a shorter debarment drug product application under sections
of actual innocence, not this remedial
period would be appropriate. 505, 512, or 802 of the FD&C Act (21
proceeding. OSI carefully reviewed Based on the factual findings in the
Fleming’s submission in its entirety, U.S.C. 355, 360b, or 382), or under
proposal to debar and on the record, OSI section 351 of the Public Health Service
and Fleming does not dispute that the finds that a 5-year debarment period for
court entered a judgment of conviction Act (42 U.S.C. 262), effective (see DATES)
each felony offense is appropriate. The (see 21 U.S.C. 335a(c)(1)(B) and
or that the court accepted his guilty nature and seriousness of Fleming’s
plea; therefore, Fleming’s arguments (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
offense, Fleming’s managerial Any person with an approved or
regarding his actual innocence fail to participation, and his lack of voluntary
raise a genuine and substantial issue of pending drug product application, who
steps to mitigate the impact on the knowingly uses the services of Fleming,
fact warranting a hearing. public weigh in favor of debarment.
Under section 306(b)(2)(B)(ii)(I) of the in any capacity during his period of
Although Fleming does not appear to debarment, will be subject to civil
FD&C Act, FDA has the authority to have prior criminal convictions
debar an individual convicted of certain money penalties (section 307(a)(6) of the
involving matters within FDA’s FD&C Act (21 U.S.C. 335b(a)(6))). If
Federal felonies, involving, among other jurisdiction, a debarment period of 5
things, fraud, if FDA finds that the Fleming, during his period of
years for each felony conviction is debarment, provides services in any
individual has demonstrated a pattern appropriate. As noted in the proposal to
of conduct giving reason to believe that capacity to a person with an approved
debar, the conduct underlying the or pending drug product application, he
he may violate requirements under the offenses involved submitting claims for
FD&C Act relating to drug products. The will be subject to civil money penalties
payment for procedures other than the
relevant factual issues are whether (section 307(a)(7) of the FD&C Act). In
procedures Fleming performed and
Fleming was, in fact, convicted of a addition, FDA will not accept or review
falsifying clinical trial data, and ‘‘[t]he
felony involving fraud and whether any abbreviated new drug applications
conduct that form[ed] the basis of [his]
there is reason to believe that he may submitted by or with the assistance of
conviction occurred in the course of
violate requirements under the FD&C Fleming during his period of debarment
[his] profession and showed disregard
Act relating to drug products. Fleming (section 306(c)(1)(B) of the FD&C Act).
for the obligations of [his] profession
does not dispute that he pled guilty to and the law.’’ Based on the pattern of Dated: September 25, 2018.
felony healthcare fraud and felony mail fraudulent conduct, FDA has reason to George M. Warren,
fraud or that, based on these believe that Fleming may violate the Director, Office of Scientific Integrity.
convictions, there is reason to believe requirements under the FD&C Act [FR Doc. 2018–21210 Filed 9–27–18; 8:45 am]
that he may violate requirements under relating to drug products. Furthermore, BILLING CODE 4164–01–P
the FD&C Act relating to drug products. given that Fleming has offered no
Therefore, Fleming has failed to raise a arguments challenging the proposed
genuine and substantial issue of fact determination regarding the extent to DEPARTMENT OF HEALTH AND
warranting a hearing regarding whether which his debarment periods should HUMAN SERVICES
he is subject to debarment. run concurrently or consecutively, OSI
Fleming’s response included one further determines that the 5-year Food and Drug Administration
argument that may be construed to be a debarment period for each felony
challenge to ORA’s proposed findings [Docket No. FDA–2018–D–3304]
conviction should run consecutively,
on the nature and seriousness of his resulting in a total debarment of 10 The Special 510(k) Program; Draft
offense. Fleming appears to claim that years. Guidance for Industry and Food and
the imaging studies he performed on his
III. Findings and Order Drug Administration Staff; Availability
patients were safer than the imaging
amozie on DSK3GDR082PROD with NOTICES1

studies he billed to Medicare and Therefore, the Director of OSI, under AGENCY: Food and Drug Administration,
Medicaid. In the proposal to debar, in section 306(b)(2)(B)(i)(I) of the FD&C HHS.
evaluating the nature and seriousness of Act and authority delegated to him by ACTION: Notice of availability.
the offenses, ORA noted that Fleming the Commissioner of Food and Drugs,
was convicted of two felonies, finds that: (1) Fleming has been SUMMARY: The Food and Drug
healthcare fraud and mail fraud. ORA convicted of a felony which involves Administration (FDA or Agency) is
considered that he billed Medicare and bribery, payment of illegal gratuities, announcing the availability of the draft

VerDate Sep<11>2014 19:22 Sep 27, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1

Document Created: 2018-09-28 01:22:21
Document Modified: 2018-09-28 01:22:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		Submit either electronic or written comments on the draft guidance by November 27, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Contact		Joshua Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301- 796-5155; Angela DeMarco, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002, 301-796-4471; 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.
FR Citation		83 FR 49097

83 FR 49097 - The Special 510(k) Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 189 (September 28, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration