[Federal Register Volume 79, Number 34 (Thursday, February 20, 2014)]
[Proposed Rules]
[Pages 9670-9671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2012-N-0378]


Physical Medicine Devices; Withdrawal of Proposed Effective Date 
of Requirement for Premarket Approval for Shortwave Diathermy for All 
Other Uses

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing the 
proposed rule the Agency issued in the Federal Register of July 6, 
2012. In that document, FDA proposed to require the filing of a 
premarket approval application (PMA) or a notice of completion of a 
product development protocol (PDP) for the class III preamendment 
device, shortwave diathermy (SWD) for all other uses. In response to 
the requirements issued in the Food and Drug Administration Safety and 
Innovation Act (FDASIA) and new information received during a panel 
meeting, FDA is withdrawing the proposed rule and proposing a different 
action.

DATES: The proposed rule is withdrawn on February 20, 2014.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993, 301-796-5616, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    In the Federal Register of July 6, 2012 (77 FR 39953), FDA issued a 
proposed rule to require the filing of a PMA or a notice of completion 
of a PDP for the class III preamendments device, SWD for all other 
uses. This device applies electromagnetic energy to the body in the 
radio frequency bands that are currently identified as 13.56 megahertz 
or 27.12 megahertz and is intended for the treatment of medical 
conditions by means other than the generation of deep heat within body 
tissues (also referred to as nonthermal SWD). It is not intended for 
treatment of malignancies. The Agency also summarized its proposed 
findings regarding the degree of risk of illness or injury designed to 
be eliminated or reduced by requiring the devices to meet the statute's 
approval requirements and the benefits to the public from the use of 
the devices. In addition, FDA announced the opportunity for interested 
persons to request that the Agency change the classification of any of 
the aforementioned devices based on new information.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126 
Stat. 1056) amended section 513(e) (U.S.C. 360c(e)) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) changing the process for 
reclassifying a device from rulemaking to an administrative order. 
Subsequent to the publication of the proposed rule, FDASIA's amendments 
to section 513 of the FD&C Act required FDA to hold a classification 
panel (an FDA advisory committee) meeting on the classification of this 
device. On May 21, 2013, FDA held a meeting of the Orthopedic and 
Rehabilitation Devices Panel (the Panel), to discuss the classification 
of nonthermal SWD devices. There was panel consensus that although the 
effectiveness data were very limited, nonthermal SWD devices did not 
fit the regulatory definition of a class III device. Coupled with the 
rationale that special controls could be established to reasonably 
demonstrate an assurance of safety and effectiveness, the Panel 
recommended class II (special controls) for nonthermal SWD devices 
(Ref. 1).

[[Page 9671]]

II. Withdrawal of the Proposed Rule

    FDA provided an opportunity for interested parties to comment on 
the proposed rule for SWD for all other uses (77 FR 39953, July 6, 
2012). FDA received over 240 comments to the docket in response to the 
2012 proposed rule. Comments that expressed an opinion about the 
classification of nonthermal SWD devices were usually in favor of a 
class II designation. Some comments did not openly state an opinion, 
but included arguments against the proposed rule that could reasonably 
be interpreted as support for a class II designation. There were also 
comments that agreed with a class III designation. In addition to the 
comments, FDA received five separate submissions to request a change in 
the classification of nonthermal SWD from class III to class II. In 
response to these comments and findings at the Panel meeting, FDA is 
withdrawing the proposed rule to call for PMAs for these devices and is 
proposing reclassification to class II (special controls).

III. Proposed Reclassification

    Elsewhere in this issue of the Federal Register, FDA is proposing 
to reclassify SWD for all other uses, currently a preamendments class 
III device, into class II (special controls), and to rename the device 
``nonthermal shortwave therapy.'' FDA continues to review the merits of 
the submissions for requests for reclassification that meet the 
requirements under 21 CFR 860.123, submitted in response to the 
proposed rule.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES), and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and are 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address, but we are not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)

1. FDA's Orthopedic and Rehabilitation Devices Panel transcript and 
other meeting materials are available on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm.

    Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03593 Filed 2-19-14; 8:45 am]
BILLING CODE 4160-01-P