[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]
BILLING CODE 4164-01-P