Document ID: FDA-2014-M-0701-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Physical Medicine Devices; Classification of the
Nonpowered Lower Extremity Pressure Wrap
Posted Date: 2014-07-03T04:00Z

[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Rules and Regulations]
[Pages 37948-37950]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15626]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2014-M-0701]

Medical Devices; Physical Medicine Devices; Classification of the 
Nonpowered Lower Extremity Pressure Wrap

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
nonpowered lower extremity pressure

[[Page 37949]]

wrap into class I (general controls). The Agency is classifying the 
device into class I (general controls) in order to provide a reasonable 
assurance of safety and effectiveness of the device.

DATES: This order is effective August 4, 2014. The classification was 
applicable on December 18, 2013.

FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1434, Silver Spring, MD 20993-0002, 301-
796-6476, michael.hoffmann@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
Under the second procedure, rather than first submitting a premarket 
notification under section 510(k) and then a request for classification 
under the first procedure, the person determines that there is no 
legally marketed device upon which to base a determination of 
substantial equivalence and requests a classification under section 
513(f)(2) of the FD&C Act. If the person submits a request to classify 
the device under this second procedure, FDA may decline to undertake 
the classification request if FDA identifies a legally marketed device 
that could provide a reasonable basis for review of substantial 
equivalence with the device or if FDA determines that the device 
submitted is not of ``low-moderate risk'' or that general controls 
would be inadequate to control the risks and special controls to 
mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device. In 
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order 
on January 7, 2011, classifying the Restless Legs Device, into class 
III, because it was not substantially equivalent to a device that was 
introduced or delivered for introduction into interstate commerce for 
commercial distribution before May 28, 1976, or a device which was 
subsequently reclassified into class I or class II. On January 23, 
2011, Mary M. Sorg dba PJ Sleeper's, submitted a request for 
classification of the Restless Leg Device under section 513(f)(2) of 
the FD&C Act. The manufacturer recommended that the device be 
classified into class I (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, 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. FDA 
classifies devices into class I if general controls by themselves are 
sufficient to provide reasonable assurance of safety and effectiveness 
of the device for its intended use. After review of the information 
submitted in the de novo request, FDA determined that the device can be 
classified into class I. FDA believes general controls will provide 
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on December 18, 2013, FDA issued an order to the 
requester classifying the device into class I. FDA is codifying the 
classification of the device by adding Sec.  890.5760. The device is 
assigned the generic name nonpowered lower extremity pressure wrap, and 
it is identified as a prescription device that applies mechanical 
pressure by wrapping around the lower extremity, such as the leg or 
foot, and is intended for primary Restless Leg Syndrome.
    FDA believes that general controls provide reasonable assurance of 
safety and effectiveness. Nonpowered lower extremity pressure wraps are 
prescription devices restricted to patient use only upon the 
authorization of a practitioner licensed by law to administer or use 
the device. ((21 CFR 882.1440(a)); see section 520(e) of the FD&C Act 
(21 U.S.C. 360j(e)) and 21 CFR 801.109 (Prescription devices).) 
Prescription-use restrictions are a type of general controls as defined 
in section 513(a)(1)(A)(i) of the FD&C Act.

II. 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.

III. Paperwork Reduction Act of 1995

    This final administrative 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. 3501-3520). The collections of 
information in 21 CFR part 801, regarding labeling, have been approved 
under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov.

    1. Request for automatic Class III designation under (De Novo) 
513(f)(2) 510(k) K102707, from Mary M. Sorg dba PJ 
Sleeper's, January 23, 2011.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
890 is amended as follows:

[[Page 37950]]

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for 21 CFR part 890 continues to read as 
follows:

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

0
2. Add Sec.  890.5760 to subpart F to read as follows:

Sec.  890.5760  Nonpowered lower extremity pressure wrap.

    (a) Identification. A nonpowered lower extremity pressure wrap is a 
prescription device that applies mechanical pressure by wrapping around 
the lower extremity, such as the leg or foot, and is intended for 
primary Restless Leg Syndrome.
    (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.  890.9.

    Dated: June 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15626 Filed 7-2-14; 8:45 am]
BILLING CODE 4164-01-P