[Federal Register Volume 85, Number 125 (Monday, June 29, 2020)]
[Notices]
[Pages 38900-38901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0914]


Review and Update of Device Establishment Inspection Processes 
and Standards; Guidance for Industry; 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 a final guidance entitled ``Review and Update of 
Device Establishment Inspection Processes and Standards.'' FDA is 
issuing this guidance to comply with changes to the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act 
of 2017 (FDARA), which requires that FDA review and update, as needed, 
the processes and standards applicable to inspections (other than for-
cause) of domestic and foreign medical device establishments in place 
as of August 18, 2017. This guidance describes how FDA will implement 
uniform inspection processes and standards. The guidance also describes 
standardized methods of communication during the inspection process and 
identifies practices for investigators and device establishments to 
facilitate the continuity of inspections of such establishments.

DATES: The announcement of the guidance is published in the Federal 
Register on June 29, 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

[[Page 38901]]

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-0914 for ``Review and Update of Device Establishment 
Inspection Processes and Standards.'' 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)).
    Submit written requests for a single hard copy of the guidance 
entitled ``Review and Update of Device Establishment Inspection 
Processes and Standards'' to the Office of Strategic Planning and 
Operational Policy, Office of Regulatory Affairs, Food and Drug 
Administration, 12420 Parklawn Dr., Element Building, Rockville, MD 
20857. Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tiffany Kelley, Office of Regulatory 
Affairs, Division of Operational Policy, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-348-1970, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is issuing this guidance document to comply with section 702(b) 
of FDARA (Pub. L. 115-52). Section 702(b) of FDARA directs FDA to issue 
guidance that specifies how FDA will implement the processes and 
standards, applicable to inspections of domestic and foreign device 
establishments, described in section 704(h)(1)(A) through (D) of the 
FD&C Act (21 U.S.C. 374(h)(1)(A) through (D)), as added by section 
702(a) of FDARA. FDARA 702(b) also requires the guidance to provide for 
standardized methods of communication when communication is required 
under section 704(h)(1) of the FD&C Act, establish a standard timeframe 
for inspections, and identify practices for investigators and device 
establishments to facilitate the continuity of inspections of such 
establishments.
    In the Federal Register of March 29, 2019 (84 FR 11983), FDA 
announced the availability of the draft guidance of the same title. FDA 
received several comments on the draft guidance and those comments were 
considered as the guidance was finalized. The guidance announced in 
this notice finalizes the draft guidance dated March 29, 2019.
    FDA is issuing this guidance consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on this topic. 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.

II. Paperwork Reduction Act of 1995

    This guidance refers to currently approved FDA 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 21 
CFR part 803 have been approved under OMB control number 0910-0437. The 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents or https://www.regulations.gov. Persons unable to download an electronic copy of 
``Review and Update of Device Establishment Inspection Processes and 
Standards; Guidance for Industry'' may send an email request to 
[email protected] to receive an electronic copy of the 
document.

    Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13972 Filed 6-26-20; 8:45 am]
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