Document ID: FDA-2019-D-3805-0001
Agency: fda
Document Type: Notice
Title: The Accreditation Scheme for Conformity Assessment Pilot Program;
Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability
Posted Date: 2019-09-23T04:00Z

[Federal Register Volume 84, Number 184 (Monday, September 23, 2019)]
[Notices]
[Pages 49741-49743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20543]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3805]

The Accreditation Scheme for Conformity Assessment Pilot Program; 
Draft Guidance for Industry, Accreditation Bodies, Testing 
Laboratories, and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``The Accreditation 
Scheme for Conformity Assessment (ASCA) Pilot Program.'' The Pilot 
Accreditation Scheme for Conformity Assessment Program (hereafter 
referred to as the ASCA Pilot) is authorized under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act). In accordance with amendments made 
to the FD&C Act by the FDA Reauthorization Act of 2017 (FDARA) and as 
part of the enactment of the Medical Device User Fee Amendments of 2017 
(MDUFA IV), FDA was directed to issue a draft guidance regarding the 
goals and implementation of the ASCA Pilot. The establishment of the 
goals, scope, procedures, and a suitable framework for the voluntary 
ASCA Pilot supports the Agency's continued efforts to use its 
scientific resources effectively to protect and promote public health 
by simplifying certain aspects of premarket review, thereby reducing 
burdens on the Agency for individual submissions. FDA believes the 
voluntary ASCA Pilot may further encourage international harmonization 
of medical device regulation because it incorporates elements, where 
appropriate, from a well-established set of international conformity 
assessment practices and standards (e.g., ISO/IEC 17000 series). The 
voluntary ASCA Pilot does not supplant or alter any other existing 
statutory or regulatory requirements governing the decision-making 
process for premarket submissions. This draft guidance is not final nor 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 December 23, 2019 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-2019-D-3805 for ``The Accreditation Scheme for Conformity 
Assessment (ASCA) Pilot Program; Draft Guidance for Industry, 
Accreditation Bodies, Testing Laboratories, and Food and Drug 
Administration Staff.'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the

[[Page 49742]]

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 Accreditation Scheme for Conformity Assessment (ASCA) Pilot 
Program; Draft Guidance for Industry, Accreditation Bodies, Testing 
Laboratories, and Food and Drug Administration Staff'' to the Office of 
Policy, 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 (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.

FOR FURTHER INFORMATION CONTACT: Erin Cutts, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5554, Silver Spring, MD 20993-0002, 301-796-6307; 
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

    The FDA Reauthorization Act of 2017 (FDARA) amended section 514 of 
the FD&C Act (21 U.S.C. 360d) by adding a new subsection (d) with the 
title ``Pilot Accreditation Scheme for Conformity Assessment'' (see 
Pub. L. 115-52, section 205). The new section 514(d) requires FDA to 
establish a pilot program under which testing laboratories may be 
accredited by accreditation bodies meeting criteria specified by FDA to 
assess the conformance of a device within certain FDA-recognized 
standards. Determinations by testing laboratories so accredited that a 
device conforms with an eligible standard included as part of the pilot 
program shall be accepted by FDA for the purposes of demonstrating such 
conformity unless FDA finds that a particular such determination shall 
not be so accepted.
    The statute provides that FDA may review determinations by 
accredited testing laboratories, including by conducting periodic 
audits of such determinations or processes of accreditation bodies or 
testing laboratories. Following such a review, or if FDA becomes aware 
of information materially bearing on safety or effectiveness of a 
device assessed by an accredited testing laboratory, FDA may take 
additional measures as determined appropriate, including suspension or 
withdrawal of accreditation of a testing laboratory or a request for 
additional information regarding a specific device.
    Under the ASCA Pilot's conformity assessment scheme, recognized 
accreditation bodies accredit testing laboratories using ASCA program 
specifications associated with each eligible standard and ISO/IEC 
17025:2017: General requirements for the competence of testing and 
calibration laboratories. ASCA-accredited testing laboratories may 
conduct testing to determine conformance of a device with at least one 
of the standards eligible for inclusion in the ASCA Pilot. When an 
ASCA-accredited testing laboratory conducts such testing, it may 
provide a complete test report to the device manufacturer containing 
the elements listed in the ASCA program specifications. A device 
manufacturer who utilizes an ASCA-accredited testing laboratory to 
perform testing in accordance with the provisions of the ASCA Pilot can 
then include a declaration of conformity with supplemental 
documentation (including a summary test report) as part of a premarket 
submission to FDA.
    FDA held a public workshop entitled ``Accreditation Scheme for 
Conformity Assessment of Medical Devices to Food and Drug 
Administration--Recognized Standards'' on May 22-23, 2018,\1\ to obtain 
input and recommendations from stakeholders about the ASCA Pilot, 
including its goals and scope as well as a suitable framework and 
procedures to facilitate implementation. The ASCA Pilot is predicated 
on the processes and policies outlined in this guidance regarding 
demonstration of competence and program participation by accreditation 
bodies and testing laboratories.
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    \1\ Federal Register Notice: https://www.federalregister.gov/documents/2018/01/16/2018-00551/accreditation-scheme-for-conformity-assessment-of-medical-devices-to-food-and-drug.
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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 current thinking of FDA on the 
``Accreditation Scheme for Conformity Assessment (ASCA) Pilot 
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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances or https://www.regulations.gov. Persons unable to 
download an electronic copy of ``The Accreditation Scheme for 
Conformity Assessment (ASCA) Pilot Program; Draft Guidance for 
Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug 
Administration Staff'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 17037 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    In the Federal Register of September 5, 2019 (84 FR 46737), FDA 
requested public comment on the collections of information associated 
with the ASCA Pilot. The proposed information collection and our burden 
estimate is substantially the same, and is meant to encompass, the 
information collections proposed in the draft guidance.
    In addition, 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

[[Page 49743]]

following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

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                                                            OMB control
    21 CFR part or guidance               Topic                 No.
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807, subpart E.................  Premarket Notification.       0910-0120
814, subparts A through E......  Premarket Approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo Classification        0910-0844
 Process (Evaluation of           Process.
 Automatic Class III
 Designation)''.
312............................  Investigational New           0910-0014
                                  Drug Application.
601............................  Biologics License             0910-0338
                                  Application.
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    Dated: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20543 Filed 9-20-19; 8:45 am]
 BILLING CODE 4164-01-P