[Federal Register Volume 82, Number 93 (Tuesday, May 16, 2017)]
[Notices]
[Pages 22548-22550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09850]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1067]


Request for Comments on Food and Drug Administration 
Accreditation Scheme for Conformity Assessment Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency), Center 
for Devices and Radiological Health (CDRH), is establishing a public 
docket to request comments related to the FDA Accreditation Scheme for 
Conformity Assessment (ASCA) Pilot Program. The purpose is to gain 
insight regarding the development and overall design/approach of the 
ASCA pilot program including program goals, pilot standards, design 
concepts, and overall program approach. The Agency is interested in 
gathering additional information to increase the efficiency of the ASCA 
Program.

DATES: Submit either electronic or written comments or information by 
June 30, 2017. Late, untimely filed comments will not be considered. 
Electronic comments must be submitted on or before June 30, 2017. The 
https://www.regulations.gov electronic filing system will accept 
comments until midnight Eastern Time at the end of June 30, 2017. 
Comments received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is on or before that date.

ADDRESSES: You may submit comments 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:

[[Page 22549]]

     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2017-N-1067 for ``Request for Comments on FDA Accreditation Scheme 
for Conformity Assessment Pilot Program.'' Received comments, those 
filed in a timely manner (see DATES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Division of Dockets 
Management 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 Division of Dockets Management. 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 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Voluntary consensus standards are technical standards developed 
among different parties including governments and standard setting 
organizations, which play an important role in establishing the safety 
and performance criteria for many aspects of medical device design and 
manufacturing. These standards help to support claims of safety and 
quality of technical information in premarket review. FDA has authority 
to recognize voluntary consensus standards for use in establishing 
safety and performance criteria for medical device design and 
manufacturing. Sponsors can include a ``Declaration of Conformity'' to 
attest to which consensus standards they used in their premarket 
applications to meet premarket requirements for their devices. However, 
the appropriate use of an FDA recognized consensus standard via a 
declaration of conformity has not been consistently applied by sponsors 
in submissions. Many standards are highly complex and require 
substantial specialized knowledge to interpret and apply correctly. 
This is a challenge for manufacturers and FDA alike. During the Medical 
Device User Fee Act reauthorization negotiations, FDA and Industry 
agreed to establish an FDA Accreditation Scheme for Conformity 
Assessment (ASCA) Program for recognizing accredited testing 
laboratories that evaluate medical devices according to certain FDA-
recognized standards. This initiative will benefit sponsors of 
submissions who can have the tests conducted at recognized accredited 
test labs and submit to FDA a determination from the test laboratory 
that their device conforms to the standards tested. FDA intends to rely 
on the results from the recognized accredited Test Laboratory for the 
purpose of premarket review without the need to address further 
questions related to standards conformance. Once developed, the ASCA 
will ease a regulatory burden on industry by allowing them to use 
recognized accredited test laboratories to ensure accurate conformance 
with the consensus standard.
    FDA is requesting comments to gain insight regarding the 
development and overall design/approach of the ASCA pilot program, 
including program goals, pilot standards, design concepts, and overall 
program approach. FDA is not endorsing any of the models proposed at 
this time. The Agency is open to considering other options or models 
for the ASCA pilot program and invites comments on any additional 
options or suggestions that may assist FDA in its decision making.
    FDA is also considering using private sector accreditation bodies 
to increase the efficiency of the ASCA Program. As a result, FDA is 
considering a number of different models to serve this purpose. FDA is 
not endorsing any of these models at this time and is open to 
considering other options or models for the ASCA pilot program.

II. Request for Comments

    The Agency invites comments on the ASCA pilot program, in general, 
and on the following questions, in particular. Each individual question 
is numbered; please clearly delineate which questions each of your 
comments are addressing in the written response.
    1. For the ASCA pilot program to achieve success,
    a. What FDA recognized consensus standards available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm need 
to be included to successfully get a sponsor/manufacturer to be willing 
to participate in the program?
    b. What impact/efficiencies would you like to see from the pilot 
program?
    c. What does success of the pilot program look like?
    d. Outline any challenges in the use of recognized voluntary 
consensus standards (e.g., acceptance of test results from accredited 
test labs, standardized test reports, consistent test methods, well-
defined standards) that FDA should focus on while developing the ASCA 
pilot?
    2. To help reduce duplicative efforts, overlap, or conflict with 
other conformity assessment schemes, what benefits/concerns of the ASCA 
work to align with other existing schemes that utilize the same 
consensus standards?
    3. What are the benefits, weaknesses, incentives/disincentives 
associated with a model that uses one or more private sector 
accreditation bodies to accredit testing laboratories to the 
appropriate scope of accreditation for ISO/IEC 17025 (General 
requirements for the

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competence of testing and calibration laboratories) or ISO 15189:2012--
Medical laboratories--Requirements for quality and competence plus FDA 
ASCA program specific requirements? FDA would still retain the 
authority to recognize, deny, amend, or revoke recognition of testing 
laboratories and maintain the official list of recognized testing 
laboratories.
    4. Where no appropriate accreditation bodies step forward to serve 
the needs for the specific areas within the ASCA program, FDA is 
considering a model under which it will serve as the accreditation 
body. What are the benefits, weaknesses, incentives/disincentives 
associated with this approach, and how do you compare this approach to 
the private sector approach?
    5. Describe your familiarity with accreditation to ISO/IEC 17025 
(General requirements for testing and calibration laboratories) or ISO 
15189:2012--Medical laboratories--Requirements for quality and 
competence? If accredited, what is the scope of accreditation?
    6. Do you utilize another management system other than ISO/IEC 
17025 or ISO 15189:2012--Medical laboratories--Requirements for quality 
and competence? If so, what management system has been implemented?
    7. Are there specific FDA recognized consensus standards available 
at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm or testing capabilities related to the medical devices 
sector that you perform?
    8. For more complex standards, such as those that have normative 
references or include references to management systems (e.g., Risk 
Management, Quality Management, Cybersecurity, Infection Control), are 
there specific assessment techniques that should be included?
    9. Would you consider participating in the ASCA Pilot Program? If 
so, what scope of testing would you consider?
    10. Generally, are there any other comments that you would like to 
provide regarding the development of the ASCA pilot program? Do you 
have recommendations for other alternatives to consider?

    Dated: May 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09850 Filed 5-15-17; 8:45 am]
 BILLING CODE 4164-01-P