Document ID: FDA-2019-D-0914-0002
Agency: fda
Document Type: Notice
Title: Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry; Availability
Posted Date: 2019-03-29T04:00Z

[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Pages 11983-11984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06061]

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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and Standards; Draft Guidance for Industry; Availability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the availability of the draft guidance entitled ``Review and Update of 
Device Establishment Inspection Processes and Standards.'' FDA is 
issuing this draft guidance document to comply with changes to the 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 This draft 
guidance describes how FDA will implement uniform inspection processes 
and standards. The draft guidance also describes standardized methods 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. This draft guidance 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DATES: Submit either electronic or written comments on the draft 
guidance by May 28, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-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.
     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

[[Page 11984]]

``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 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)).
    Submit written requests for a single hard copy of the draft 
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 draft 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 announcing the availability of a draft guidance for industry 
entitled, ``Review and Update of Device Establishment Inspection 
Processes and Standards.'' FDA is issuing this guidance document to 
comply with section 702(b) of FDARA (Pub. L. 115-52), which directs FDA 
to issue draft guidance that specifies how FDA will review processes 
and standards applicable to inspections of domestic and foreign device 
establishments in effect as of August 18, 2017, and update such 
processes and standards, as needed, through the adoption of uniform 
processes and standards that meet the criteria set forth 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 draft guidance to provide for standardized methods of 
communication when communication is required under 704(h)(1), establish 
a standard timeframe for inspections, and identify practices for 
investigators and device establishments to facilitate the continuity of 
inspections of such establishments.

II. Significance of Draft Guidance

    FDA is issuing this draft guidance 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 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. This guidance 
is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to currently 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 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.

IV. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet at either 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Review and Update of Device Establishment 
Inspection Processes and Standards; Draft Guidance for Industry'' may 
send an email request to [email protected] to receive an 
electronic copy of the document.

    Dated: March 25, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06061 Filed 3-28-19; 8:45 am]
 BILLING CODE 4164-01-P