Rule2022-03104
Medical Devices; General Hospital and Personal Use Devices; Classification of the Spore Test Strip
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
February 14, 2022
Effective
February 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 30 (Monday, February 14, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#783b14190a1d161b1d56350d0a0a1901381e1c195610100b561f170e"><span class="__cf_email__" data-cfemail="11527d7063747f72743f5c6463637068517775703f7979623f767e67">[email protected]</span></a>.
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 log<INF>10</INF> 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 log<INF>10</INF> spores/strip. It does not confirm the
expected full performance of the liquid chemical sterilant processing
cycle because full performance is a 6 log<INF>10</INF> 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 log<INF>10</INF> 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 log<INF>10</INF> spores/
strip; it does not confirm the expected full performance of the liquid
chemical sterilant processing cycle because full performance is a 6
log<INF>10</INF> 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 log<INF>10</INF> 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
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</html>Indexed from Federal Register on February 14, 2022.
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