Rule2025-11796
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test
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
June 26, 2025
Effective
June 26, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying the muscular dystrophy newborn screening test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the muscular dystrophy newborn screening test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Full Text
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<title>Federal Register, Volume 90 Issue 121 (Thursday, June 26, 2025)</title>
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[Federal Register Volume 90, Number 121 (Thursday, June 26, 2025)]
[Rules and Regulations]
[Pages 27227-27229]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11796]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA-2025-N-1245]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Muscular Dystrophy Newborn Screening
Test
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the muscular dystrophy newborn screening test into class II
(special controls). The special controls that apply to the device type
are identified in this order and will be part of the codified language
for the muscular dystrophy newborn screening test's classification. We
are taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.
DATES: This order is effective June 26, 2025. The classification was
applicable on December 12, 2019.
FOR FURTHER INFORMATION CONTACT: Irene Tebbs, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3526, Silver Spring, MD 20993-0002, 240-402-0283,
<a href="/cdn-cgi/l/email-protection#c58cb7a0aba0eb91a0a7a7b685a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="ce87bcaba0abe09aabacacbd8ea8aaafe0a6a6bde0a9a1b8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the muscular dystrophy newborn
screening test as class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into a lower device class than the automatic class
III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo application
process by adding a second procedure. A device sponsor may utilize
either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to
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beneficial innovation, in part by reducing regulatory burdens. When FDA
classifies a device into class I or II via the De Novo process, the
device can serve as a predicate for future devices of that type,
including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As
a result, other device sponsors do not have to submit a De Novo request
or premarket approval application to market a substantially equivalent
device (see section 513(i) of the FD&C Act, defining ``substantial
equivalence''). Instead, sponsors can use the less burdensome 510(k)
process, when necessary, to market their device.
II. De Novo Classification
On November 4, 2019, FDA received PerkinElmer Inc.'s request for De
Novo classification of the GSP Neonatal Creatine Kinase--MM kit. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 513(a)(1)(B) of the FD&C Act). After review of
the information submitted in the request, we determined that the device
can be classified into class II with the establishment of special
controls. FDA has determined that these special controls, in addition
to the general controls, will provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on December 12, 2019, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
862.1506.\1\ We have named the generic type of device muscular
dystrophy newborn screening test, and it is identified as an in vitro
diagnostic device that is intended to measure creatine kinase levels
obtained from dried blood spot specimens on filter paper from newborns
as an aid in screening newborns for muscular dystrophy.
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\1\ FDA notes that the ACTION caption for this final order is
styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--Muscular Dystrophy Newborn Screening Test Risks and Mitigation
Measures
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Identified risks to health Mitigation measures
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Risk of False Negative Results......... Certain design verification and
validation activities, and
Certain labeling information.
Risk of False Positive Results......... Certain design verification and
validation activities, and
Certain labeling information.
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this final order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. 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. 3501-3521). The collections
of information in part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions have been approved under OMB control
number 0910-0120; the collections of information in 21 CFR part 820
regarding quality system regulation have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
parts 801 and 809 regarding labeling have been approved under OMB
control number 0910-0485.
List of Subjects in 21 CFR Part 862
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
862 is amended as follows:
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
0
1. The authority citation for part 862 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 862.1506 to subpart B to read as follows:
Sec. 862.1506 Muscular dystrophy newborn screening test.
(a) Identification. A muscular dystrophy newborn screening test is
an in vitro diagnostic device intended to measure creatine kinase
levels obtained from dried blood spot specimens on filter paper from
newborns as an aid in screening newborns for muscular dystrophy.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include a clinical
validation study that includes the following:
(i) Results that demonstrate that the analyte being measured
identifies a
[[Page 27229]]
population of newborns who should be subject to follow up diagnostic
testing for the condition being screened.
(ii) Predictive value of the device demonstrated using either well
characterized prospectively or retrospectively obtained clinical
specimens from the intended use population.
(iii) Testing performed by device users who are representative of
the types of operators intended to use the test.
(iv) A design that assesses the effects of sample collection and
processing steps on test performance.
(v) Tested confirmed positive specimens must have associated
diagnostic outcome information based on confirmatory diagnostic
methods, or clinically meaningful information regarding the status of
the subject must be obtained.
(vi) Data, provided or referenced, generated in samples from the
intended use population, that demonstrates the upper reference
interval(s), including sufficient samples to calculate the 97.5th and
99.5th percentile information, for the analyte or analytes measured by
the device.
(2) The labeling required under Sec. 809.10(b) of this chapter
must include:
(i) A warning which states that test results are not intended to
diagnose muscular dystrophies.
(ii) A warning which states that test results are intended to be
used in conjunction with other clinical and diagnostic findings,
consistent with professional standards of practice, including
confirmation by alternative methods, and clinical evaluation as
appropriate.
(iii) Detailed information on device performance, including the
false positive screen rate and the false negative screen rate observed
in the clinical study, and any limitations to the data generated in the
clinical study (e.g., necessity for testing at a specific age).
(iv) Information on device performance in relevant subgroups (e.g.,
age of newborn at time of sample collection, birth weight, sex,
gestational age) observed in the clinical study.
Dated: June 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11796 Filed 6-25-25; 8:45 am]
BILLING CODE 4164-01-P
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