[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Notices]
[Pages 60471-60474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21234]


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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; 
Guidances 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 three final guidance documents for the 
Accreditation Scheme for Conformity Assessment Pilot Program--
specifically, ``The Accreditation Scheme for Conformity Assessment 
(ASCA) Pilot Program; Guidance for Industry, Accreditation Bodies, 
Testing Laboratories, and FDA Staff''; ``Basic Safety and Essential 
Performance of Medical Electrical Equipment, Medical Electrical 
Systems, and Laboratory Medical Equipment--Standards Specific 
Information for the Accreditation Scheme for Conformity Assessment 
(ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, 
Testing Laboratories, and FDA Staff''; and ``Biocompatibility Testing 
of Medical Devices--Standards Specific Information for the 
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: 
Guidance for Industry, Accreditation Bodies, Testing Laboratories, and 
FDA Staff.'' These guidances describe the goals, scope, procedures, and 
framework for the voluntary ASCA Pilot program, and provide information 
about two groups of consensus standards within the scope of the pilot 
program.

DATES: The announcement of these guidances is published in the Federal 
Register on September 25, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 60472]]

(ASCA) Pilot Program; Guidances for Industry, Accreditation Bodies, 
Testing Laboratories, and FDA Staff''; ``Basic Safety and Essential 
Performance of Medical Electrical Equipment, Medical Electrical 
Systems, and Laboratory Medical Equipment--Standards Specific 
Information for the Accreditation Scheme for Conformity Assessment 
(ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, 
Testing Laboratories, and FDA Staff''; and ``Biocompatibility Testing 
of Medical Devices--Standards Specific Information for the 
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: 
Guidance for Industry, Accreditation Bodies, Testing Laboratories, and 
FDA 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Electronic copies of these three guidance documents are available 
for download from the internet. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidances. Submit 
written requests for single hard copies of the guidance documents 
entitled ``The Accreditation Scheme for Conformity Assessment (ASCA) 
Pilot Program; Guidance for Industry, Accreditation Bodies, Testing 
Laboratories, and FDA Staff''; ``Basic Safety and Essential Performance 
of Medical Electrical Equipment, Medical Electrical Systems, and 
Laboratory Medical Equipment--Standards Specific Information for the 
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: 
Guidance for Industry, Accreditation Bodies, Testing Laboratories, and 
FDA Staff''; or, ``Biocompatibility Testing of Medical Devices--
Standards Specific Information for the Accreditation Scheme for 
Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, 
Accreditation Bodies, Testing Laboratories, and FDA Staff'' to the 
Office of Policy, 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 Center for Biologics Evaluation and 
Research, Office of Communication, Outreach, and Development, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20903. 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, 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 paragraph (d) with the 
title ``Pilot Accreditation Scheme for Conformity Assessment'' (see 
Pub. L. 115-52, section 205). The new paragraph 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, ASCA-
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 provide data used 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 testing 
under the ASCA Pilot, it provides to the device manufacturer all 
information listed in the ASCA program specifications, which includes 
an ASCA summary test report. A device manufacturer that uses 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 any necessary supplemental documentation (e.g., ASCA 
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, to obtain 
input and recommendations from stakeholders about the ASCA Pilot, 
including its goals and scope as well as

[[Page 60473]]

a suitable framework and procedures to facilitate implementation.
    FDA considered comments received on the draft guidance ``The 
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program'' 
that appeared in the Federal Register of September 23, 2019 (https://www.govinfo.gov/content/pkg/FR-2019-09-23/pdf/2019-20543.pdf). FDA 
revised the guidance as appropriate in response to the comments. In 
particular, FDA added clarifications and details regarding the ASCA 
Pilot and its implementation, including changing terminology to 
describe whether a testing laboratory or accreditation body is 
participating in the program; providing additional information on how 
and when FDA will conduct audits under the ASCA Pilot; and clarifying 
who is responsible for developing test methods and completing the ASCA 
summary test report. In addition, FDA added several appendices, 
including an example declaration of conformity for each set of 
standards in the program, as well as additional example ASCA summary 
test reports for biocompatibility testing of medical devices. For ease 
of reading and organizational purposes, FDA separated the document, 
issued in draft, into three separate guidance documents for final 
publication.
     ``The Accreditation Scheme for Conformity Assessment 
(ASCA) Pilot Program; Guidance for Industry, Accreditation Bodies, 
Testing Laboratories, and FDA Staff'' describes how the ASCA Pilot was 
designed and how accreditation bodies, testing laboratories, device 
manufacturers, and FDA staff participate in the program.
     ``Basic Safety and Essential Performance of Medical 
Electrical Equipment, Medical Electrical Systems, and Laboratory 
Medical Equipment--Standards Specific Information for the Accreditation 
Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for 
Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff'' 
provides information specific to the basic safety and essential 
performance standards in the ASCA Pilot, including which standards are 
eligible for inclusion in the program, ASCA program specifications for 
those standards, and recommended premarket submission contents specific 
to those standards when testing is conducted by an ASCA-accredited 
testing laboratory.
     ``Biocompatibility Testing of Medical Devices--Standards 
Specific Information for the Accreditation Scheme for Conformity 
Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation 
Bodies, Testing Laboratories, and FDA Staff'' provides information 
specific to the biological evaluation of medical device standards and 
test methods in the ASCA Pilot, including which standards and test 
methods are eligible for inclusion in the program, ASCA program 
specifications for those standards and test methods, and recommended 
premarket submission contents specific to those standards and test 
methods when testing is conducted by an ASCA-accredited testing 
laboratory.
    These guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These guidances 
represents the current thinking of FDA on the ``Accreditation Scheme 
for Conformity Assessment (ASCA) Pilot Program''; ``Basic Safety and 
Essential Performance of Medical Electrical Equipment, Medical 
Electrical Systems, and Laboratory Medical Equipment--Standards 
Specific Information for the Accreditation Scheme for Conformity 
Assessment (ASCA) Pilot Program''; and ``Biocompatibility Testing of 
Medical Devices--Standards Specific Information for the Accreditation 
Scheme for Conformity Assessment (ASCA) Pilot Program.'' They do 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.

II. Electronic Access

    Persons interested in obtaining a copy of these guidances 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. These 
guidance documents are also available at https://www.regulations.gov or 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to 
download an electronic copy of ``The Accreditation Scheme for 
Conformity Assessment (ASCA) Pilot Program; Guidance for Industry, 
Accreditation Bodies, Testing Laboratories, and FDA Staff;'' ``Basic 
Safety and Essential Performance of Medical Electrical Equipment, 
Medical Electrical Systems, and Laboratory Medical Equipment--Standards 
Specific Information for the Accreditation Scheme for Conformity 
Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation 
Bodies, Testing Laboratories, and FDA Staff;'' or ``Biocompatibility 
Testing of Medical Devices--Standards Specific Information for the 
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: 
Guidance for Industry, Accreditation Bodies, Testing Laboratories, and 
FDA Staff'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the following 
document numbers to identify the guidance you are requesting.
     Document number 17037 for ``The Accreditation Scheme for 
Conformity Assessment (ASCA) Pilot Program; Guidance for Industry, 
Accreditation Bodies, Testing Laboratories, and FDA Staff''.
     Document number 20011 for ``Basic Safety and Essential 
Performance of Medical Electrical Equipment, Medical Electrical 
Systems, and Laboratory Medical Equipment--Standards Specific 
Information for the Accreditation Scheme for Conformity Assessment 
(ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, 
Testing Laboratories, and FDA Staff''.
     Document number 20012 for ``Biocompatibility Testing of 
Medical Devices--Standards Specific Information for the Accreditation 
Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for 
Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff''.

III. 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 information collection and our burden estimate 
is substantially the same, and is meant to encompass, the information 
collections proposed in the guidances (OMB control number 0910-0889).
    These guidances refer 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. 3501-3521). The collections of information in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

[[Page 60474]]



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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.
820............................  Quality System                0910-0073
                                  Regulation.
803............................  Medical Device                0910-0437
                                  Reporting.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
``Requests for Feedback and      Q-submissions..........       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
58.............................  Good Laboratory               0910-0119
                                  Practices.
312............................  Investigational New           0910-0014
                                  Drug Application.
601............................  Biologics License             0910-0338
                                  Application.
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    Dated: September 22, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21234 Filed 9-24-20; 8:45 am]
BILLING CODE 4164-01-P