Rule2024-18264
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Selected Microbial Agents That Cause Acute Febrile Illness
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
August 16, 2024
Effective
August 16, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify selected microbial agents that cause acute febrile illness 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 device to detect and identify selected microbial agents that cause acute febrile illness'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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 159 (Friday, August 16, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 159 (Friday, August 16, 2024)]
[Rules and Regulations]
[Pages 66556-66558]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-18264]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2024-N-3358]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Detect and Identify Selected Microbial
Agents That Cause Acute Febrile Illness
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the device to detect and identify selected microbial agents
that cause acute febrile illness 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 device to
detect and identify selected microbial agents that cause acute febrile
illness'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.
DATES: This order is effective August 16, 2024. The classification was
applicable on November 20, 2020.
FOR FURTHER INFORMATION CONTACT: Bryan Grabias, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3260, Silver Spring, MD 20993-0002, 240-402-9563,
<a href="/cdn-cgi/l/email-protection#b5f7c7ccd4db9bf2c7d4d7dcd4c6f5d3d1d49bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="490b3b302827670e3b282b20283a092f2d286721213a672e263f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the device to detect and identify
selected microbial agents that cause acute febrile illness 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 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 (see 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 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
[[Page 66557]]
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.
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 June 26, 2020, FDA received BioFire Defense, LLC's request for
De Novo classification of the FilmArray Global Fever Panel. 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 21 U.S.C. 360c(a)(1)(B)). 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 November 20, 2020, 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
866.3966.\1\ We have named the generic type of device as a device to
detect and identify selected microbial agents that cause acute febrile
illness, and it is identified as an in vitro device intended for the
detection and identification of microbial agents in human clinical
specimens from patients with signs and symptoms of acute febrile
illness who are at risk for exposure or who may have been exposed to
these agents. It is intended to aid in the diagnosis of acute febrile
illness in conjunction with other clinical, epidemiologic, and
laboratory data, including patient travel, pathogen endemicity, or
other risk factors.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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--Device To Detect and Identify Selected Microbial Agents That
Cause Acute Febrile Illness Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Risk of an inaccurate test result Certain labeling information,
(false positive or false negative including certain limiting
result) leading to improper patient statements and performance
management. information; Certain design
verification and validation,
including certain analytical
studies and clinical studies;
and Use of certain specimen
collection devices.
Misinterpretation of test results Certain labeling information,
leading to misdiagnosis and associated including certain limiting
risk of false test results. statements and performance
information; and Certain
design verification and
validation, including certain
analytical studies and
clinical studies.
Failure to correctly operate the device Certain labeling information,
leading to inaccurate test results. including certain limiting
statements and performance
information; Certain design
verification and validation,
including certain analytical
studies and clinical studies;
and Use of certain specimen
collection devices.
------------------------------------------------------------------------
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. In order 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 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
[[Page 66558]]
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 866
Biologics, Laboratories, 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
866 is amended as follows:
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
0
1. The authority citation for part 866 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 866.3966 to read as follows:
Sec. 866.3966 Device to detect and identify selected microbial agents
that cause acute febrile illness.
(a) Identification. A device to detect and identify selected
microbial agents that cause acute febrile illness is identified as an
in vitro device intended for the detection and identification of
microbial agents in human clinical specimens from patients with signs
and symptoms of acute febrile illness who are at risk for exposure or
who may have been exposed to these agents. It is intended to aid in the
diagnosis of acute febrile illness in conjunction with other clinical,
epidemiologic, and laboratory data, including patient travel, pathogen
endemicity, or other risk factors.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Any sample collection device used must be FDA-cleared, -
approved, or -classified as 510(k) exempt (standalone or as part of a
test system) for the collection of specimen types claimed by this
device; alternatively, the sample collection device must be cleared in
a premarket submission as a part of this device.
(2) The labeling required under Sec. 809.10(b) of this chapter
must include:
(i) An intended use that includes a detailed description of targets
the device detects and measures, the results provided to the user, the
clinical indications appropriate for test use, and the specific
population(s) for which the device is intended.
(ii) Limiting statements indicating:
(A) Not all pathogens that cause febrile illness are detected by
this test and negative results do not rule out the presence of other
infections;
(B) Evaluation of more common causes of acute febrile illness
should be considered prior to evaluation with this test;
(C) Test results are to be interpreted in conjunction with other
clinical, epidemiologic, and laboratory data available to the
clinician; and
(D) When using this test, consider patient travel history and
exposure risk, as some pathogens are more common in certain
geographical locations.
(iii) A detailed device description, including reagents,
instruments, ancillary materials, all control elements, and a detailed
explanation of the methodology, including all pre-analytical methods
for processing of specimens.
(iv) Detailed discussion of the performance characteristics of the
device for all claimed specimen types as shown by the analytical and
clinical studies required under paragraphs (b)(3)(ii) and (iii) of this
section, except specimen stability performance characteristics.
(v) A statement that nationally notifiable results are to be
reported to public health authorities in accordance with local, state,
and federal law.
(3) Design verification and validation must include:
(i) A detailed device description (e.g., all device parts, control
elements incorporated into the test procedure, reagents required but
not provided, the principle of device operation and test methodology),
and the computational path from collected raw data to reported result
(e.g., how collected raw signals are converted into a reported result).
(ii) Detailed documentation of analytical studies, including those
demonstrating Limit of Detection (LoD), inclusivity, cross-reactivity,
microbial interference, interfering substances, competitive inhibition,
carryover/cross contamination, specimen stability, within lab
precision, and reproducibility, as appropriate.
(iii) Detailed documentation and performance results from a
clinical study that includes prospective (sequentially collected)
samples for each claimed specimen type and, when determined to be
appropriate by FDA, additional characterized clinical samples. The
study must be performed on a study population consistent with the
intended use population and compare the device performance to results
obtained from FDA-accepted comparator methods. Documentation from the
clinical studies must include the clinical study protocol (including a
predefined statistical analysis plan), study report, testing results,
and results of all statistical analyses.
(iv) A detailed description of the impact of any software,
including software applications and hardware-based devices that
incorporate software, on the device's functions.
Dated: August 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18264 Filed 8-15-24; 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 August 16, 2024.
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.