Document ID: FDA-2021-N-0994-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; General Hospital and Personal Use Devices; Classification of the Spore Test Strip
Posted Date: 2022-02-14T05:00Z

[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Rules and Regulations]
[Pages 8192-8194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03104]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. FDA-2021-N-0994]

Medical Devices; General Hospital and Personal Use Devices; 
Classification of the Spore Test Strip

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 spore test strip 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 spore test 
strip'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 February 14, 2022. The classification 
was applicable on March 30, 2012.

FOR FURTHER INFORMATION CONTACT: Clarence Murray III, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4506, Silver Spring, MD 20993-0002, 
301-796-0270, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the spore test strip 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. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation

[[Page 8193]]

Act modified the De Novo application process by adding a second 
procedure (Pub. L. 112-144). 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 beneficial innovation. 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 (PMA) 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

    For this device, FDA issued an order on July 1, 2011, finding the 
VERIFY S40 Biological Indicator Kit not substantially equivalent to a 
predicate not subject to PMA. Thus, the device remained in class III in 
accordance with section 513(f)(1) of the FD&C Act when we issued the 
order.
    On August 1, 2011, FDA received STERIS Corporation's request for De 
Novo classification of the VERIFY Spore Test Strip for S40. 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 March 30, 2012, 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 
880.6887.\1\ We have named the generic type of device spore test strip, 
and it consists of a carrier or strip with a known number of spores, at 
least 5 log10 per strip, of known resistance to a particular 
liquid chemical sterilant in a liquid chemical sterilant processing 
system. A ``no growth'' result from the spore test strip after the 
specified predetermined incubation period indicates that the liquid 
chemical sterilization process achieved the conditions necessary to 
kill the specified minimum number of viable spores on the test strip, 
which is 5 log10 spores/strip. It does not confirm the 
expected full performance of the liquid chemical sterilant processing 
cycle because full performance is a 6 log10 spore kill in a 
full liquid chemical sterilization cycle.
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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--Spore Test Strip Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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User handling error due to false fail    Spore strip characterization,
 spore test strip device result due to    Simulated use testing, Shelf
 technical malfunction.                   life, and Labeling.
User handling error due to false pass    Spore strip characterization,
 spore test strip device result due to    Simulated use testing, Shelf
 technical malfunction.                   life, and Labeling.
User handling error due to               Labeling.
 misunderstanding spore test strip
 device use instructions.
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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 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. 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 
the guidance document ``De Novo Classification Process (Evaluation of

[[Page 8194]]

Automatic Class III Designation)'' 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 part 801, regarding labeling, have 
been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 880

    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 
880 is amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
1. The authority citation for part 880 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  880.6887 to subpart G to read as follows:

Sec.  880.6887  Spore test strip.

    (a) Identification. The spore test strip consists of a carrier or 
strip with a known number of spores, at least 5 log10 per 
strip, of known resistance to a particular liquid chemical sterilant in 
a liquid chemical sterilant processing system. A ``no growth'' result 
from the spore test strip after the specified predetermined incubation 
period indicates that the liquid chemical sterilization process 
achieved the conditions necessary to kill the specified minimum number 
of viable spores on the test strip which is 5 log10 spores/
strip; it does not confirm the expected full performance of the liquid 
chemical sterilant processing cycle because full performance is a 6 
log10 spore kill in a full liquid chemical sterilization 
cycle.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Spore strip characterization. (i) Population of viable spores 
on strip shall be a minimum of 5 log10 after physical wash 
off of spores from the strip by exposure to liquid chemical sterilant 
in the liquid chemical sterilant processing system, which should be 
validated over the claimed shelf life.
    (ii) The resistance characteristics of the viable spores on the 
strip should be defined and be validated over the claimed shelf life.
    (iii) The spore strip description should address the carrier 
material, how the spores are placed on the carrier, and whether there 
is any feature that minimizes spore wash off. Bacteriostasis of the 
spore strip materials should be evaluated.
    (iv) Incubation time for viable spores on the strip should be 
validated under the specified incubation conditions over the claimed 
shelf life.
    (2) Simulated Use Testing. Simulated use testing should demonstrate 
performance of spore test strip in liquid chemical sterilant/high level 
disinfectant under worst case in use conditions over the claimed shelf 
life.
    (3) Labeling. Labeling should specify appropriate instructions, 
warnings, cautions, limitations, and information relating to viable 
spore population, resistance characteristics, and interpretation of a 
``no growth'' result.

    Dated: February 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03104 Filed 2-11-22; 8:45 am]
BILLING CODE 4164-01-P