[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Rules and Regulations]
[Pages 70733-70735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2021-N-0898]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Pressure Ulcer Management Tool

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the pressure ulcer management tool into class I. We are taking this 
action because we have determined that classifying the device into 
class I 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 December 13, 2021. The classification 
was applicable on December 20, 2018.

FOR FURTHER INFORMATION CONTACT: Gema Gonzalez, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2530, Silver Spring, MD 20993-0002, 301-796-6519, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the pressure ulcer management tool 
as class I, which we have determined will provide a reasonable 
assurance of safety and effectiveness. In addition, we believe this 
action will enhance

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patients' access to beneficial innovation 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 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.
    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 April 3, 2017, FDA received Bruin Biometrics, LLC's request for 
De Novo classification of the SEM Scanner (Model 200). 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 I if general controls are sufficient 
to provide reasonable assurance of the safety and effectiveness of the 
device for its intended use (see 21 U.S.C. 360c(a)(1)(A)). After review 
of the information submitted in the request, we determined that the 
device can be classified into class I. FDA has determined that general 
controls will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on December 20, 2018, FDA issued an order to the 
requester classifying the device into class I. In this final order, FDA 
is codifying the classification of the device by adding 21 CFR 
876.2100.\1\ We have named the generic type of device pressure ulcer 
management tool, and it is identified as a prescription device intended 
for patients at risk of developing pressure ulcers. The device provides 
output that supports a user's decision to increase intervention. The 
device is an adjunct tool for pressure ulcer management that is not 
intended for detection or diagnostic purposes.
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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: Adverse tissue reaction, 
transmission of infection between patients, electromagnetic 
interference with patient monitoring equipment, and electrical shock. 
As previously stated, FDA believes general controls provide reasonable 
assurance of safety and effectiveness for this device type.
    At the time of classification, pressure ulcer management tools are 
for prescription use only. Prescription devices are exempt from the 
requirement for adequate directions for use for the layperson under 
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 
801.5, as long as the conditions of 21 CFR 801.109 are met.
    Section 510(l)(1) of the FD&C Act provides that a device within a 
type that has been classified into class I under section 513 of the 
FD&C Act is exempt from premarket notification under section 510(k), 
unless the device is of substantial importance in preventing impairment 
of human health or presents a potentially unreasonable risk of illness 
or injury (21 U.S.C. 360(l)(1)). Devices within this type are exempt 
from the premarket notification requirements under section 510(k), 
subject to the limitations of exemptions in 21 CFR 876.9.

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 refers 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 the guidance 
document ``De Novo Classification Process (Evaluation of 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; and the collections of

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information in part 807, subpart E, regarding premarket notification 
submissions, have been approved under OMB control number 0910-0120.

List of Subjects in 21 CFR Part 876

    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 
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

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


0
2. Add Sec.  876.2100 to subpart C to read as follows:


Sec.  876.2100  Pressure ulcer management tool.

    (a) Identification. A pressure ulcer management tool is a 
prescription device intended for patients at risk of developing 
pressure ulcers. The device provides output that supports a user's 
decision to increase intervention. The device is an adjunct tool for 
pressure ulcer management that is not intended for detection or 
diagnostic purposes.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec.  876.9.

    Dated: December 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26924 Filed 12-10-21; 8:45 am]
BILLING CODE 4164-01-P