Review and Update of Device Establishment Inspection Processes and Standards: Guidance for Industry

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Review and Update of Device
Establishment Inspection
Processes and Standards
Guidance for Industry
Document issued on June 29, 2020.
The draft of this document was issued on March 29, 2019.
For questions about this document contact the Office of Regulatory Affairs (ORA) Office of
Strategic Planning and Operational Policy (OSPOP) at ORAPolicyStaffs@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
Identify all comments with the docket number FDA-2019-D-0914. Comments may not be acted
upon by the Agency until the document is next revised or updated.
Additional Copies
ORA
Additional copies are available from the Internet. You may also send an e-mail request to
ORAPolicyStaffs@fda.hhs.gov to receive a copy of the guidance.
CDRH
Additional copies from the Center for Devices and Radiological Health (CDRH) are available
from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to
receive a copy of the guidance.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER)
by written request, Office of Communication, Outreach and Development, Bldg. 71, Room 3128,
10903 New Hampshire Ave., Silver Spring, MD 20993; by telephone, 1-800-835-4709 or 240-
402-8010; by email, ocod@fda.hhs.gov; or from the Internet at
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/defaul
t.htm.

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1
Review and Update of Device
Establishment Inspection Processes
and Standards
Guidance for Industry
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) 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. To discuss an alternative approach, contact the FDA staff
or Office responsible for this guidance as listed on the title page.
I. 	INTRODUCTION
FDA is issuing this guidance to comply with section 702(b)(2) of the FDA Reauthorization Act
of 2017 (FDARA) (Public Law 115-52), which directs FDA to issue guidance that specifies how
the Agency will implement uniform processes and standards1 that are applicable to inspections
(other than for-cause)2 of foreign and domestic device establishments.3 FDA updated processes
and standards as needed to address the new provisions in section 704(h)(1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) that were added by FDARA section 702(a) and to establish
a standard timeframe for inspections. This 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.
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
1 As used in this guidance, the term “standards” refers to “a level of quality or attainment” and does not refer to a
“voluntary consensus standard” as described in Office of Management and Budget Circular No. A-119 at
https://www.nist.gov/sites/default/files/revised_circular_a-119_as_of_01-22-2016.pdf.
2 Section 704(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) applies to “inspections other than for-
cause inspections” only. Therefore, as used in this guidance, “inspection” does not include for-cause inspections.
The inspections within the scope of this guidance are conducted in accordance with a risk-based schedule pursuant
to section 510(h)(2) of the FD&C Act.
3 The uniform processes and standards in this guidance apply to inspections of device establishments required to be
registered with the Secretary, including but not limited to establishments required to register under 21 CFR 607.80
and 21 CFR 1271.1(b)(2).

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cited. The use of the word should in Agency guidance means that something is suggested or
recommended, but not required.
II. 	BACKGROUND
On August 18, 2017, FDARA was signed into law. Among other things, FDARA added section
704(h)(1) to the FD&C Act. This provision requires FDA to review processes and standards
applicable to inspections of domestic and foreign device establishments and update such
processes and standards, as necessary, through the adoption of uniform processes and standards
applicable to such inspections. Section 704(h)(1) of the FD&C Act specifies that the updated
uniform processes and standards will describe how FDA should, among other things, pre-
announce inspections of device establishments within a reasonable time before the inspection
begins, provide a reasonable estimated timeframe for inspections, and ensure regular
communication with the owner, operator, or agent in charge of the establishment during
inspections.
Section 702(b) of FDARA instructs FDA to issue this guidance to describe how it is
implementing section 704(h)(1) of the FD&C Act, 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.
III. 	DISCUSSION
Pursuant to section 704(h)(1) of the FD&C Act, as added by FDARA, FDA reviewed the
processes and standards applicable to inspections of foreign and domestic device establishments
that were in place as of August 18, 2017. The review encompassed FDA guidances, manuals,
programs, and internal standard operating procedures related to device establishment inspections.
As a result of this review, FDA identified uniform processes and standards and drafted revisions
to update procedural documents, including the Investigations Operations Manual and training
materials, where necessary, to align with these processes and standards.
FDA believes that uniformity in investigators’ approaches to inspections, both before and during,
may inform firms’ preparation for the inspection and set baseline communication and timing
expectations for each party. The processes and standards identified below should facilitate
practices that encourage continuity within an inspection and consistency across inspections.
Section 704(h)(1)(A) of the FD&C Act allows FDA to establish exceptions to the updated
processes and standards, as appropriate.
Pre-announcement Notice and Communication
FDA intends to make reasonable efforts to make contact with the firm to preannounce the
inspection. Under the uniform processes and standards, an investigator notifies the owner,
operator, or agent in charge of a device establishment by telephone before their facility

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undergoes an inspection. While FDA intends to seek acknowledgement of the pre-
announcement notification from the firm, FDA believes the firm’s failure to acknowledge the
notification should not be a reason to delay the start of an inspection. Under the statute, this
notification will be provided within a reasonable time before the inspection is scheduled to
occur. For domestic inspections, the pre-announcement should be no less than five calendar days
in advance of the inspection. The pre-announcement for foreign inspections is generally more
than five calendar days due to the requirements of particular country clearances. For both
domestic and foreign inspections, the notification should include information about the type and
nature of the inspection, such as whether the inspection is scheduled as surveillance or pre-
approval.
Updated processes specify that during pre-announcement, investigators should communicate
with the firm regarding the planned timeframe and duration of the inspection, to include
appropriate working hours during which the inspection is likely to take place. To the extent
possible, FDA should also provide advance notice of some records that may be requested during
the inspection (e.g., certain procedures and any associated records).
Under 704(h)(1) of the FD&C Act, FDA retains authority to conduct unannounced, for-cause
inspections.
Standard Inspection Timeframe
FDA standards for reasonable estimated timeframes of inspections generally range from 3 to 6
continuous business days. These standards are based on the type of surveillance inspection
(abbreviated or comprehensive) and the extent of coverage needed for a pre-approval inspection.
The estimated duration for each inspection should be shared with the firm at the time of pre-
announcement. Inspection duration is impacted by factors such as the complexities of the firm’s
operations, availability of knowledgeable staff, and the nature of observed deficiencies.
Additionally, it may be necessary to extend the duration of an inspection for a number of
reasons, including for FDA to follow-up on post-market safety information such as recalls,
Medical Device Reports, and complaints received by the Agency. Updated processes provide
that, unless an investigator or the firm identifies a reason that additional time is needed and
communicates this verbally to the other party, inspections of both domestic and foreign device
establishments should take place within a standard timeframe and occur over consecutive
business days. FDA recognizes that circumstances may arise, for either FDA or the firm, where
exceptions to these timeframes may be appropriate. Exceptions to the timeframe should be
communicated verbally during the course of the inspection.
Communication During Inspections
FDA’s updated processes also address regular verbal communications during the inspection
between the investigator and the owner, operator, or agent in charge of the device establishment
about the status of the inspection. When time and circumstances permit, investigators should
make every reasonable effort to discuss all observations with the owner, operator, or agent in

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charge of the device establishment as they are observed, or on a daily basis, to minimize errors
and misunderstandings. These discussions may address observations not documented on the
FDA Form 483 that require clarification. Communications may be recorded by either FDA or
the firm, if there is advance notice and mutual consent by the other party.4
4 FDA recordings will be treated in accordance with applicable disclosure laws including sections 301(j) and 520(c)
of the FD&C Act (21 U.S.C. 331(j), 360j(c)) and the Freedom of Information Act (5 U.S.C. 552).