[Federal Register Volume 89, Number 122 (Tuesday, June 25, 2024)]
[Notices]
[Pages 53109-53110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13872]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2177]
Laboratory Developed Tests: Small Entity Compliance Guide;
Guidance for Laboratory Manufacturers 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 a final guidance entitled ``Laboratory Developed
Tests: Small Entity Compliance Guide.'' The laboratory developed tests
(LDT) final rule amended FDA's regulations to make explicit that in
vitro diagnostic products (IVDs) are devices under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of
the IVD is a laboratory. This small entity compliance guide (SECG) is
intended to help small entities comply with applicable medical device
regulations, consistent with the LDT final rule, including the phasing
out of FDA's general enforcement discretion approach for LDTs so that
IVDs manufactured by a laboratory will generally fall under the same
enforcement approach as other IVDs.
DATES: The announcement of the guidance is published in the Federal
Register on June 25, 2024.
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-2023-N-2177 for ``Laboratory Developed Tests: Small Entity
Compliance Guide.'' 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)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Laboratory Developed Tests: Small Entity Compliance Guide'' 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. Send one self-addressed adhesive label to
assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Brittany Schuck, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5422, Silver Spring, MD 20993-0002, 301-
796-5199, [email protected]; or James Myers, 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
In the Federal Register of May 6, 2024 (89 FR 37286), FDA issued a
final rule to amend its regulations to make explicit that IVDs are
devices under the FD&C Act including when the
[[Page 53110]]
manufacturer of the IVD is a laboratory. The final rule, which is
codified at 21 CFR 809.3, is effective July 5, 2024. In conjunction
with this amendment, the FDA is phasing out its general enforcement
discretion approach for LDTs so that IVDs manufactured by a laboratory
will generally fall under the same enforcement approach as other IVDs.
This phaseout policy includes enforcement discretion policies for
specific categories of IVDs manufactured by a laboratory, including
currently marketed IVDs offered as LDTs and LDTs for unmet needs. This
phaseout policy is intended to better protect the public health by
helping to assure the safety and effectiveness of IVDs offered as LDTs,
while also accounting for other important public health considerations
such as patient access and reliance. FDA has prepared this SECG to
assist small entities in complying with the requirements established in
FDA regulations, as they apply to IVDs, including LDTs.
This level 2 guidance is being issued consistent with our good
guidance practices regulation (21 CFR 10.115(c)(2)). The SECG
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. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
II. Electronic Access
Persons interested in obtaining a copy of the guidance 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Laboratory Developed Tests: Small Entity Compliance Guide; Guidance
for Laboratory Manufacturers and Food and Drug Administration Staff''
may send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number
GUI00007036 and complete title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The following collections of
information have been approved by OMB: OMB control number 0910-0437,
Medical Device Reporting; OMB control number 0910-0359, Corrections and
Removals; OMB control number 0910-0625, Device Registration and
Listing; OMB control number 0910-0485, Device Labeling; OMB control
number 0910-0078, Investigational Device Exemption; OMB control number
0910-0073, Quality Systems, including Sec. 820.198 (complaint files);
OMB control number 0910-0231, Premarket Approval; OMB control number
0910-0332, Humanitarian Device Exemption; OMB control number 0910-0120,
Premarket Notification; OMB control number 0910-0844 De Novo Requests;
OMB control number 0910-0338, Biologics License Applications Procedures
& Requirements; OMB control number 0910-0052, Blood Establishment
Registration and Product Listing for Manufacturers of Human Blood and
Blood Products and Licensed Devices; OMB control number 0910-0014,
Investigational use requirements under 42 U.S.C. 262 and 21 CFR part
312 for certain devices that are biological products; and OMB control
number 0910-0756, FDA's final guidance document entitled ``Requests for
Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program.''
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13872 Filed 6-24-24; 8:45 am]
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