Rule2025-18239
Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 19, 2025
Effective
September 19, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
On May 6, 2024, the Food and Drug Administration (FDA, the Agency, or we) issued a final rule amending the definition of "in vitro diagnostic products" in FDA's regulations. On March 31, 2025, a federal district court vacated that rule. This final rule reverts to the text of the regulation as it existed prior to the effective date of the May 2024 final rule.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 180 (Friday, September 19, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 180 (Friday, September 19, 2025)]
[Rules and Regulations]
[Pages 45134-45136]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18239]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 809
[Docket No. FDA-2025-N-1730]
Regulation Identification Number 0910-AJ05 Medical Devices;
Laboratory Developed Tests; Implementation of Vacatur
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On May 6, 2024, the Food and Drug Administration (FDA, the
Agency, or we) issued a final rule amending the definition of ``in
vitro diagnostic products'' in FDA's regulations. On March 31, 2025, a
federal district court vacated that rule. This final rule reverts to
the text of the regulation as it existed prior to the effective date of
the May 2024 final rule.
DATES: This rule is effective September 19, 2025.
FOR FURTHER INFORMATION CONTACT: Eitan Bernstein, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 240-402-9812,
<a href="/cdn-cgi/l/email-protection#bdf1f9e9fbd4d3dcd1efc8d1d8fddbd9dc93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="c589819183acaba4a997b0a9a085a3a1a4ebadadb6eba2aab3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 6, 2024, FDA published a final rule
entitled ``Medical Devices; Laboratory Developed Tests'' (89 FR 37286)
(codified at 21 CFR 809.3) (the Rule). The Rule added the words
``including when the manufacturer of these products is a laboratory''
to the Agency's regulations at 21 CFR 809.3(a).
On March 31, 2025, the United States District Court for the Eastern
District of Texas issued a final judgment in Am. Clinical Lab'y Ass'n
v. FDA, No. 4:24-CV-479-SDJ, 2025 U.S. Dist. LEXIS 59869 (E.D. Tex.
Mar. 31, 2025), vacating and setting aside the Rule and remanding the
matter to the Secretary of Health and Human Services for further
consideration.
II. Description of the Amendment
FDA is removing the words ``including when the manufacturer of
these products is a laboratory'' from 21 CFR 809.3(a), reverting to the
text of the regulation as it existed prior to the effective date of the
Rule. This update is being made to reflect the court's order vacating
the Rule.\1\
---------------------------------------------------------------------------
\1\ The Rule also amended the statutory citation for the device
definition included in 21 CFR 809.3 to reflect that the statutory
definition is now codified at section 201(h)(1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act). Reverting to the text of the
regulation as codified prior to the effective date of the Rule
includes amending the statutory citation to revert to section 201(h)
of the FD&C Act, which citation remains accurate but is less
specific.
---------------------------------------------------------------------------
III. Notice and Public Comment
Under the Administrative Procedure Act (APA) at 5 U.S.C. 551(4), a
rule means ``the whole or a part of an agency statement of general or
particular applicability and future effect designed to implement,
interpret, or prescribe law or policy or describing the organization,
procedure, or practice requirements of an agency.'' Under the APA at 5
U.S.C. 553(b)(B), notice and comment rulemaking procedures generally do
not apply when an agency for good cause finds that such procedures
would be ``impracticable, unnecessary, or contrary to the public
interest.''
FDA has determined that this final rule meets the APA's notice and
comment exemption under 5 U.S.C. 553(b)(B). On March 31, 2025, the
United States District Court for the Eastern District of Texas vacated
and set aside the Rule. Because the Rule has already been vacated, this
action is ministerial in nature and merely removes text from the Code
of Federal Regulations to reflect the court's order. Accordingly, FDA
for good cause finds that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest.
The APA allows an effective date less than 30 days after
publication of a rule as ``provided by the agency for good cause found
and published with the rule'' (5 U.S.C. 553(d)(3)). An effective date
30 or more days from the date of publication is unnecessary because a
court has already vacated the Rule. This action does not impose any new
regulatory requirements on affected parties, and affected parties do
not need time to ``adjust to the new regulation''
[[Page 45135]]
before the rule takes effect. Am. Federation of Government Emp., AFL-
CIO v. Block, 655 F.2d 1153, 1156 (D.C. Cir. 1981). Therefore, FDA for
good cause finds that this action may become effective on the date of
its publication.
IV. Economic Analysis of Impacts
We have examined the impacts of this action under Executive Order
12866, Executive Order 13563, and Executive Order 14192.
Executive Orders 12866 and 13563 direct us to assess all benefits
and costs of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits.
Rules are economically significant under Executive Order 12866 if they
have an annual effect on the economy of $100 million or more; or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities. The Office of Information and Regulatory Affairs (OIRA)
has determined that this action is a significant regulatory action
under Executive Order 12866.
Executive Order 14192 requires that any new incremental costs
associated with certain significant regulatory actions ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least 10 prior regulations.'' This action is
considered an Executive Order 14192 deregulatory action.
On May 6, 2024, FDA published the Rule. The primary estimate of the
total annualized cost of the Rule over a 20-year time horizon was $1.29
billion at a 7 percent discount rate and $1.37 billion at a 3 percent
discount rate, both reported in constant 2022 dollars. We report these
costs in constant 2024 dollars as $1,384.98 million at 7 percent
discount rate and $1,475.93 million at 3 percent discount rate after
adjusting for inflation using the GDP deflator. For purposes of
estimating the cost savings of the vacatur of the Rule, costs for
reading and understanding the Rule represent sunk costs while the
remaining costs constitute cost savings.\2\ The estimated sunk cost of
the Rule is $0.34 million at 7 percent discount rate and $0.25 million
at 3 percent discount rate.
---------------------------------------------------------------------------
\2\ The costs associated with reading and understanding the Rule
would have been incurred any time after publication of the rule (May
2024) up to the start of the first stage of the phaseout policy
described in the preamble to the Rule (May 2025). Because the Rule
has been vacated, these costs are now considered ``sunk costs.'' A
sunk cost is money that has already been spent that cannot be
recovered, no matter what decision is made going forward. Since we
don't have data on what portion of affected entities has already
incurred these costs, we use the total estimated costs for reading
and understanding the Rule to estimate sunk costs. The actual sunk
cost is likely lower.
---------------------------------------------------------------------------
Table 1 summarizes the estimated forgone benefits and cost savings
resulting from the Rule no longer being in effect. A simple reversal of
the estimates published with the Rule indicates that now, the
annualized forgone benefits over 20 years would be $3,723.39 million
and $4,606.01 million and at 7 and 3 percent discount rate,
respectively. The total annualized cost savings are $1,444.45 million
and $1,539.50 million at 7 and 3 percent discount rate, respectively.
The annualized cost savings of $1,444.45 million represent $1,365.53
million to domestic entities and $78.92 million in pass-through cost
savings from foreign entities at a 7 percent discount rate. Similarly,
the annualized cost savings of $1,539.50 million represent $1,455.14
million to domestic entities and $84.35 million in pass-through cost
savings from foreign entities at a 3 percent discount rate.\3\ Portions
of the broader benefit and cost uncertainty ranges overlap, thus
indicating the possibility of negative net benefits of the Rule and
positive net benefits of its no longer being in effect. Moreover, the
quantitative estimates omit various regulatory consequences that are
especially challenging to assess, such as any possible effect on
innovation related to laboratory-developed tests (LDTs) associated with
the Rule.
---------------------------------------------------------------------------
\3\ We estimate pass-through cost savings from foreign entities
by assuming that 50 percent of foreign costs would be passed on to
the U.S. market. Costs to foreign entities of the Rule in 2024
dollars over 20 years were estimated at $157.85 million and $168.71
million at 7 and 3 percent discount rate, respectively. The
estimated pass-through costs savings are $78.92 ($157.85 x 0.5)
million and $84.35 ($168.71 x 0.5) million at 7 and 3 percent
discount rate, respectively.
Table 1--Summary of Benefits and Costs Associated With the Vacatur of the Rule
[Millions of 2024 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
Primary High ------------------------------------
Category estimate Low estimate estimate Year Discount Period Notes
dollars rate (%) covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized ($millions/year).. $(3,723.39) $(11,773.23) $(1,048.05) 2024 7 2025-2044 ..............................
(4,606.01) (14,450.60) (1,319.58) 2024 3
Annualized Quantified.................. ............ ............ ........... .......... 7 .......... ..............................
............ ............ ........... .......... 3 ..........
------------------------------------------------------------------------------------------------------------
Qualitative............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized ($millions/year).. (1,444.45) (3,882.26) (671.17) 2024 7 2025-2044 Total cost savings include
(1,539.50) (4,134.71) (715.01) 2024 3 domestic cost savings and
foreign pass-through cost
savings.
Annualized Quantified.................. ............ ............ ........... .......... 7 .......... ..............................
............ ............ ........... .......... 3 ..........
------------------------------------------------------------------------------------------------------------
Qualitative............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized ($millions/ ............ ............ ........... 2024 7 .......... ..............................
year). ............ ............ ........... 2024 3 ..........
------------------------------------------------------------------------------------------------------------
From:
To: ..........
------------------------------------------------------------------------------------------------------------
[[Page 45136]]
Other Annualized Monetized ($millions/ ............ ............ ........... .......... 7 .......... ..............................
year). ............ ............ ........... .......... 3 ..........
------------------------------------------------------------------------------------------------------------
From:
To: ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: .................................................................................................................
Small Business:.....................................................................................................................................
Wages:..............................................................................................................................................
Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Values in parentheses denote negative values.
In line with Executive Order 14192, in Table 2 we estimate present
and annualized values of costs, cost savings, and net costs over a
perpetual time horizon. For this analysis, we assume that the costs of
the Rule in years 21 and beyond would be equal to the costs of the Rule
in year 20. When estimating the cost savings of the vacatur of the
Rule, we include cost savings that will similarly extend in perpetuity.
We estimate that this action is associated with $1,423.23 million in
annualized net cost savings at a 7 percent discount rate, discounted
relative to year 2024, over a perpetual time horizon.
Table 2--Executive Order 14192 Summary Table
[Millions of 2024 dollars, discounted over a perpetual time horizon relative to year 2024 at a 7 percent
discount rate]
----------------------------------------------------------------------------------------------------------------
Primary
estimate Low estimate High estimate
----------------------------------------------------------------------------------------------------------------
Present Value of Costs.......................................... $0 $0 $0
Present Value of Cost Savings................................... 20,331.91 12,675.63 44,468.47
Present Value of Net Costs...................................... (20,331.91) (12,675.63) (44,468.47)
Annualized Costs................................................ 0 0 0
Annualized Cost Savings......................................... 1,423.23 887.29 3,112.79
Annualized Net Costs............................................ (1,423.23) (887.29) (3,112.79)
----------------------------------------------------------------------------------------------------------------
Note: Values in parentheses denote net negative costs (i.e., net cost savings).
List of Subjects in 21 CFR Part 809
Labeling, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
809 is amended as follows:
PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
0
1. The authority citation for part 809 continues to read as follows:
Authority: 21 U.S.C. 321(h)(1), 331, 351, 352, 360, 360c, 360d,
360e, 360h, 360i, 360j, 371, 372, 374, 381, and 42 U.S.C. 262.
0
2. In Sec. 809.3, revise the last sentence of paragraph (a) to read as
follows:
Sec. 809.3 Definitions.
(a) * * * These products are devices as defined in section 201(h)
of the Federal Food, Drug, and Cosmetic Act (the act), and may also be
biological products subject to section 351 of the Public Health Service
Act.
* * * * *
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services
[FR Doc. 2025-18239 Filed 9-18-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 19, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.