Document ID: FDA-2012-N-0378-0049
Agency: fda
Document Type: Proposed Rule
Title: Physical Medicine Devices; Reclassification and Renaming of
Shortwave Diathermy for All Other Uses
Posted Date: 2014-02-20T05:00Z

[Federal Register Volume 79, Number 34 (Thursday, February 20, 2014)]
[Proposed Rules]
[Pages 9671-9677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03594]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

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

Physical Medicine Devices; Reclassification and Renaming of 
Shortwave Diathermy for All Other Uses

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order; technical correction.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify the shortwave diathermy (SWD) for all other uses, a 
preamendments class III device, into class II (special controls), and 
to rename the device ``nonthermal shortwave therapy (SWT).'' FDA is 
proposing this reclassification on its own initiative based on new 
information. FDA is also proposing a technical correction in the 
regulation for the carrier frequency for SWD and nonthermal SWT 
devices. This proposed action would implement certain regulatory 
requirements.

DATES: Submit either electronic or written comments on this proposed 
order by May 21, 2014. February 21, 2014FDA intends that SWD devices 
for all other uses must comply with the special controls and must 
submit a premarket notification (510(k)) within 60 days after the 
effective date of the final order. See Section XII for the proposed 
effective date of a final order based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0378, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2012-N-0378 for this rulemaking. All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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, 
Melissa.Burns@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by 
the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the 
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub. 
L. 107-250), the Medical Devices Technical Corrections Act of 2004 
(Pub. L. 108-214), the Food and Drug Administration Amendments Act of 
2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Pub. L. 112-144) established a comprehensive 
system for the regulation of medical devices intended for human use. 
Section 513 of the FD&C Act (21 U.S.C. 360c) established three 
categories (classes) of devices, reflecting the regulatory controls 
needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Section 513(a)(1) of the FD&C Act defines class II devices as those 
devices for which the general controls by themselves are insufficient 
to provide reasonable assurance of safety and effectiveness, but for 
which there is sufficient information to establish

[[Page 9672]]

special controls to provide such assurance.
    Under section 513 of the FD&C Act, devices that were in commercial 
distribution before the enactment of the 1976 amendments, May 28, 1976 
(generally referred to as preamendments devices), are classified after 
FDA has: (1) Received a recommendation from a device classification 
panel (an FDA advisory committee); (2) published the panel's 
recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976 (generally referred to as postamendments devices), are 
automatically classified by section 513(f) of the FD&C Act into class 
III without any FDA rulemaking process. Those devices remain in class 
III and require premarket approval unless, and until, the device is 
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 part 807 (21 CFR part 807).
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA 
amended section 513(e) of the FD&C Act, changing the process for 
reclassifying a device from rulemaking to an administrative order. 
Section 513(e) of the FD&C Act governs reclassification of classified 
preamendments devices. This section provides that FDA may, by 
administrative order, reclassify a device based upon ``new 
information.'' FDA can initiate a reclassification under section 513(e) 
of the FD&C Act or an interested person may petition FDA to reclassify 
a preamendments device. The term ``new information,'' as used in 
section 513(e) of the FD&C Act, includes information developed as a 
result of a reevaluation of the data before the Agency when the device 
was originally classified, as well as information not presented, not 
available, or not developed at that time. (See, e.g., Holland Rantos v. 
United States Department of Health, Education, and Welfare, 587 F.2d 
1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th 
Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 
F.Supp. 382, 389-391 (D.D.C. 1991)) or in light of changes in ``medical 
science'' (see Upjohn v. Finch, supra, 422 F.2d at 951). Whether data 
before the Agency are past or new data, the ``new information'' to 
support reclassification under section 513(e) must be ``valid 
scientific evidence,'' as defined in 21 CFR 860.7(c)(2). (See, e.g., 
General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens 
Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 
1062 (1986)).
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the valid scientific 
evidence upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).) Section 
513(e)(1) of the FD&C Act sets forth the process for issuing a final 
reclassification order. Specifically, prior to the issuance of a final 
order reclassifying a device, the following must occur: (1) Publication 
of a proposed reclassification order in the Federal Register; (2) a 
meeting of a device classification panel described in section 513(b) of 
the FD&C Act; and (3) consideration of comments to a public docket.
    In accordance with section 513(e)(1) of the FD&C Act, the Agency is 
proposing, based on new information that has come to the Agency's 
attention, to reclassify SWD for all other uses because general 
controls and special controls are sufficient to provide a reasonable 
assurance of safety and effectiveness. Therefore, this order proposes 
to reclassify SWD for all other uses into class II (special controls) 
and to rename the device nonthermal SWT; see Section III for more 
information on the name change. In addition, in this proposed order to 
reclassify the device to class II with special controls, FDA requires 
manufacturers of currently marketed SWD for all other uses to submit 
510(k)s.
    Section 510(m) of the FD&C Act provides that a class II device may 
be exempted from the premarket notification requirements under section 
510(k) of the FD&C Act, if the Agency determines that premarket 
notification is not necessary to assure the safety and effectiveness of 
the device. FDA has determined that premarket notification is necessary 
to assure the safety and effectiveness of SWD for all other uses.

II. Regulatory History of the Device

    On November 23, 1983, in the Federal Register (48 FR 53047), FDA 
published a final rule for classification of SWD for all other uses as 
class III requiring premarket approval based on recommendations made by 
the Physical Medicine Device Classification Panel of 1979 (the 1979 
Panel). The 1979 Panel made preliminary classification recommendations 
for physical medicine devices during a series of meetings: August 14 
and 15, 1975, March 21 and 22, 1976, March 18, 1977, October 14, 1977, 
and March 17, 1978. Included in this group of devices were SWD devices. 
The 1979 Panel recommended splitting the classification for SWD 
devices: SWD devices that are capable of generating therapeutic heat in 
specific areas of the body were recommended to be class II. However, 
SWD devices for any use other than delivering therapeutic deep heat 
(also referred to as nonthermal SWD) were recommended to be class III.
    In 1987, FDA published a clarification by inserting language in the 
codified language stating that no effective date had been established 
for the requirement for premarket approval for SWD devices for any use 
other than delivering therapeutic deep heat (52 FR 17732, May 11, 
1987).
    In 2009, FDA published an order in the Federal Register under 
section 515(i) of the FD&C Act (21 U.S.C. 360i) to call for information 
on the remaining class III 510(k) devices (74 FR 16214, April 9, 2009). 
In response to that order, FDA received submissions from five SWD 
device manufacturers suggesting that nonthermal SWD devices could be 
reclassified to class II. The manufacturers stated that safety and 
effectiveness of these devices may be assured by general and special 
controls. Prior to enactment of FDASIA, FDA published a proposed rule 
in the Federal Register (77 FR 39953, July 6, 2012) to require filing 
of PMAs for nonthermal SWD devices. 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.

[[Page 9673]]

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.
    Subsequent to the issuance of the proposed rule, FDASIA made 
amendments to section 513 of the FD&C Act that required FDA to hold a 
panel meeting on the classification of preamendment devices and publish 
an administrative order for reclassification of preamendment devices 
instead of rulemaking. On May 21, 2013, FDA held a meeting of the 
Orthopedic and Rehabilitation Devices Panel (the 2013 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 necessarily fit the regulatory 
definition of a class III device (life supporting, life sustaining, or 
of substantial importance to health). Coupled with the rationale that 
special controls could be established to reasonably demonstrate an 
assurance of safety and effectiveness, the 2013 Panel recommended the 
device be class II (special controls) for nonthermal SWD devices (Ref. 
1). FDA is issuing this proposed order to comply with the procedural 
requirements created by FDASIA. As a result, elsewhere in this issue of 
the Federal Register, FDA is withdrawing the proposed rule issued on 
July 6, 2012, calling for PMAs and PDPs for this device pursuant to 
515(b) of the FD&C Act. However, 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.

III. Device Description

    SWD devices intended for therapeutic use produce a radiofrequency 
(RF) signal that is generated by electronic circuitry at one of two 
frequencies designated by the U.S. Federal Communications Commission 
(FCC): 27.12 or 13.56 megahertz (MHz) to induce electrical currents and 
voltages in body tissues. The RF signal is delivered to an antenna or 
applicator that produces electromagnetic fields external to the 
applicator. Electric and magnetic fields are induced in body tissues by 
the applicator.
    FDA has differentiated two types of SWD devices that have been 
cleared through the 510(k) process: thermal and nonthermal. Thermal SWD 
devices are designed to deliver therapeutic deep heat below the surface 
of the skin. Nonthermal SWD devices do not provide therapeutic deep 
heat and do not intend to demonstrate a sustained temperature increase 
within the tissue. Nonthermal SWD devices are intended to produce their 
effect in tissue only through means other than therapeutic deep 
heating.
    Because the term diathermy refers to therapeutic elevation of 
temperature in the tissues, nonthermal diathermy is a misnomer. FDA is 
proposing in this order to modify the name of the identification from 
how it is presently written in Sec.  890.5290(b) (21 CFR 890.5290(b)) 
for additional clarification. FDA is proposing to rename this class of 
devices from SWD for all other uses to SWT.
    Equipment to deliver SWT can be designed to emit either a pulsatile 
(pulsed) or a continuous wave output and sometimes provides both types 
of output. Thermal SWD systems cleared by FDA provide continuous wave 
or pulsed output and achieve therapeutic deep heating of tissues as 
noted above. Nonthermal SWT devices cleared by FDA deliver RF energy 
only in a pulsatile fashion and do not provide therapeutic deep heat to 
the tissues.

IV. Proposed Reclassification

    FDA is proposing that SWD for all other uses be reclassified from 
class III to class II. FDA is also proposing to rename these devices 
from ``shortwave diathermy for all other uses'' to ``nonthermal 
shortwave therapy.'' In this proposed order, the Agency has identified 
special controls under section 513(a)(1)(B) of the FD&C Act that, if 
finalized, together with general controls (including prescription-use 
restrictions) applicable to the devices, would provide reasonable 
assurance of their safety and effectiveness. Absent the special 
controls identified in this proposed order, general controls applicable 
to the device are insufficient to provide reasonable assurance of the 
safety and effectiveness of the device.
    Therefore, in accordance with sections 513(e) and 515(i) of the 
FD&C Act and Sec.  860.130 (21 CFR 860.130), based on new information 
with respect to the devices and taking into account the public health 
benefit of the use of the device and the nature and known incidence of 
the risks of the device, FDA, on its own initiative, is proposing to 
reclassify this preamendments class III device into class II. FDA 
believes that this new information is sufficient to demonstrate that 
the proposed special controls can effectively mitigate the risks to 
health identified in Section V, and that these special controls, 
together with general controls, will provide a reasonable assurance of 
safety and effectiveness for nonthermal SWT devices.
    Section 510(m) of the FD&C Act authorizes the Agency to exempt 
class II devices from premarket notification (510(k)) submission. FDA 
has considered nonthermal SWT devices in accordance with the reserved 
criteria set forth in section 513(a) of the FD&C Act and has determined 
that the device does require premarket notification (510(k)). 
Therefore, the Agency does not intend to exempt this proposed class II 
device from premarket notification (510(k)) submission as provided for 
under section 510(m) of the FD&C Act. As stated in Section I, FDA will 
also require manufacturers of currently marketed SWD for all other uses 
devices to submit 510(k)s.
    FDA is also proposing a technical correction in the regulation for 
the carrier frequency for these devices from ``13 MHz to 27.12 MHz'' to 
``13.56 MHz or 27.12 MHz.'' The FCC has allocated the shortwave 
frequencies of 13.56 MHz and 27.12 MHz for medical equipment (Ref. 2). 
This applies to both SWD devices for use in applying therapeutic deep 
heat for selected medical conditions (Sec.  890.5290(a)) and nonthermal 
SWT devices (Sec.  890.5290(b)).

V. Risks to Health

    After considering available information, including the 
recommendations of the panel meeting on nonthermal SWT devices held on 
May 21, 2013, FDA has reevaluated the risks to health associated with 
the use of nonthermal SWT and made revisions from those previously 
identified in a proposed rule issued in the Federal Register on July 6, 
2012 (77 FR 39953). FDA has determined that the following risks to 
health are associated with the use of nonthermal SWT:
     Cellular or tissue injury: Nonthermal biological effects 
of nonionizing radiation may cause cellular or tissue injury.
     Electromagnetic interference: The electromagnetic fields 
generated by the device may interfere with the circuitry of other 
patient systems, causing adverse events in the patient, as well as 
adversely affecting the performance of the other patient systems, such 
as cardiac pacemaker and implantable defibrillator.
     Tissue necrosis (tissue death) and burns: Excessive energy 
deposition into the tissue may cause excessive heating that results in 
tissue damage.
     Electrical shock: Electrical shock hazards may pose a 
potential hazard to both operators and users. Excessive leakage current 
from the device could

[[Page 9674]]

result in injury, or a malfunction of the device could result in 
electrical shock.
     Thermal injury from implanted leads and implanted systems 
with leads: Interaction of the RF energy with an implanted lead may 
cause excessive heating in the tissue surrounding the lead electrodes.
     Adverse tissue reaction: Device materials that are not 
biocompatible may either directly or through the release of their 
material constituents: (i) produce adverse local or systemic effects, 
(ii) be carcinogenic, or (iii) produce adverse reproductive and 
developmental effects. Although medical devices may have myriad 
biocompatibility issues, the biocompatibility concerns from nonthermal 
SWT devices are likely limited to skin reactions from contact with the 
materials from which the applicator is made.
     Adverse pregnancy outcome: Exposure to the device during 
pregnancy can lead to congenital anomalies.
     Risk to children: Exposure to the device can affect the 
growth plates in children if applied over the growth plates.
     Ineffective treatment: Ineffective treatments can result 
in increased morbidity, delayed discharge after ambulatory surgery, and 
hospital readmission.
    The following additional risks to health were identified by the 
submitters and acknowledged by the 2013 Panel: Pain, bleeding, feeling 
chilly and cold in response to treatment, pins and needles sensation, 
gout attack in patients with pre-existing gout, mild numbness in the 
area of treatment, abdominal pain, chest wall sensation, malaise, and 
headache. Many of these are infrequent and related to pain (which is 
already present in this patient population), the underlying condition 
being treated, or to the surgical procedures that precede the use of 
the device. Therefore, FDA does not consider these additional risks to 
health as being associated with the use of nonthermal SWT. The 2013 
Panel also acknowledged the risk of cancer progression and metastasis, 
although there was some disagreement among panel members on whether it 
should be included. This risk was primarily based on literature from in 
vitro test data, which associates device use with the upregulation of 
certain cytokines and proteases that play a role in metastasis. FDA is 
not aware of any animal data, clinical data, or adverse event reports 
that attribute cancer progression or metastasis to nonthermal SWT. 
Therefore, FDA does not consider this a risk as being associated with 
the use of nonthermal SWT.

VI. Summary of Reasons for Reclassification

    Based on the comments from the 2013 Panel meeting, the comments 
received in response to FDA's prior proposed rule (77 FR 39953, July 6, 
2012), and FDA's assessment of new, valid scientific data related to 
the health benefits and risks associated with nonthermal SWT, FDA is 
proposing that these devices should be reclassified from class III to 
class II because special controls, in addition to general controls, can 
be established to provide reasonable assurance of safety and 
effectiveness of the device, and because general controls themselves 
are insufficient to provide a reasonable assurance of its safety and 
effectiveness. In addition, there is now sufficient information to 
establish special controls to provide such assurance.
    FDA has been reviewing these devices for many years, and their 
risks are well known. A review of the applicable clinical literature 
indicates that few relevant adverse events have been reported for these 
devices or related devices suggesting that the device has a long-term 
safety profile. If properly manufactured and used as intended, FDA 
believes that the special controls identified in this proposed order, 
if finalized, together with general controls (including prescription-
use restrictions and 510(k) notification requirements), are adequate to 
provide a reasonable assurance of safety and effectiveness for this 
device.

VII. Summary of Data Upon Which the Reclassification Is Based

    FDA believes that the identified special controls, in addition to 
general controls, are sufficient to provide reasonable assurance of 
safety and effectiveness of these devices. Therefore, in accordance 
with sections 513(e) and 515(i) of the FD&C Act and Sec.  860.130, 
based on new information with respect to the device and taking into 
account the public health benefit of the use of the device and the 
nature and known incidence of the risk of the device, FDA, on its own 
initiative, is proposing to reclassify this preamendments class III 
device into class II. The Agency has identified special controls that 
would provide reasonable assurance of their safety and effectiveness. 
FDA's review of the clinical literature has been previously summarized 
in the Executive Summary to the 2013 Panel meeting to discuss 
nonthermal SWT classification (Ref. 3).
    In addition, the 2013 Panel reviewed and discussed recent 
information presented by FDA, manufacturers of SWT devices, and members 
of the public. This information included recent literature regarding 
the possible risks to health and a review of FDA's Manufacturer and 
User Facility Device Experience database.
    The 2013 Panel agreed that nonthermal SWT devices are not ``life-
supporting or life-sustaining, or of substantial importance in 
preventing impairment of human health.'' The 2013 Panel agreed on the 
potential risks to health identified by FDA and the additional risks to 
health identified in the comments received in response to the July 6, 
2012, proposed rule (77 FR 39953). However, the 2013 Panel expressed 
uncertainty regarding ``abnormal cell growth'' as a risk to health, but 
suggested that cell membrane injury is also a potential risk to health. 
The 2013 Panel recommended that the following additional risks to 
health be included, as they were reported by those who submitted 
requests to change the classification: Adverse pregnancy outcome, 
cancer and tumor promotion, skin reactions, pain, bleeding, ineffective 
treatment, risk to children, feeling chilly and cold in response to 
treatment, sensation of localized warmth, pins and needles sensation, 
gout attack in patients with pre-existing gout, mild numbness in the 
area of treatment, abdominal pain, chest wall sensation, and headache. 
FDA acknowledges cellular or tissue injury, electromagnetic 
interference, tissue necrosis (tissue death) and burns, electrical 
shock, thermal injury from implanted leads and implanted systems with 
leads, adverse tissue reaction, adverse pregnancy outcome, risk to 
children, and ineffective treatment as risks to health for these 
devices. As explained in Section V, FDA does not believe valid 
scientific evidence supports the other additional risks identified by 
the 2013 Panel as being associated with the use of nonthermal SWT.
    Regarding the benefits of nonthermal SWT devices, the 2013 Panel 
indicated that a certain subset of patients may benefit, but there were 
concerns about the veracity and the limitations of clinical trials 
reported in the literature. They further commented that there was 
limited clinical evidence presented to demonstrate effectiveness. The 
most compelling effectiveness evidence was presented for post-breast 
surgery. The 2013 Panel noted that the effect on edema was less 
convincing.
    Regarding classification, there was general panel consensus that

[[Page 9675]]

nonthermal SWT devices for adjunctive used in palliative treatment of 
postoperative pain and edema should be class II devices with special 
controls. There was also general consensus by the 2013 Panel that 
special controls that included labeling, biocompatibility testing, 
electrical safety testing, electromagnetic compatibility, nonclinical 
performance testing, and clinical performance data were appropriate. 
The 2013 Panel recommended that clinical data are necessary as a 
special control and also recommended studies should include the 
following basic study design elements:
     Randomization;
     Sham control group;
     Well-defined patient population, e.g. patients having a 
specific surgical procedure;
     Well-defined SWT treatment parameters and device settings;
     Clinically relevant validated measures of effectiveness;
     Adequate power and sample size;
     Appropriate predefined statistical methods;
     Predefined hypothesis and success criteria; and
     Systematic collection of adverse events.
    No 2013 Panel member recommended leaving these devices in class 
III. Regarding the issue of general controls, the 2013 Panel agreed 
that general controls alone are not sufficient to provide reasonable 
assurance of the safety and effectiveness of nonthermal SWT devices.

VIII. Proposed Special Controls

    FDA believes that the following special controls, in addition to 
general controls, are sufficient to mitigate the risks to health 
described in Section V:
    1. Components of the device that come into human contact must be 
demonstrated to be biocompatible. These devices can contact users' skin 
directly; therefore, a demonstration of biocompatibility would mitigate 
the risks of skin reactions.
    2. Appropriate analysis/testing must demonstrate that the device is 
electrically safe and electromagnetically compatible in its intended 
use environment. The requirement to demonstrate electromagnetic 
compatibility would, in concert with other special controls, help 
ensure the mitigation of discomfort, pain, and tenderness resulting 
from burns to the skin due to excessive energy deposition by preventing 
electromagnetic interference with device hardware and software. In 
addition, this requirement would ensure the device does not interfere 
with other electrical equipment and would also ensure that both 
operators and users are properly protected from electrical hazards such 
as electrical shock.
    3. Non-clinical testing must demonstrate that the device performs 
as intended under anticipated conditions of use. Non-clinical 
performance testing must characterize the output waveform of the device 
and demonstrate that the device meets appropriate output performance 
specifications. This requirement would mitigate the risks of cellular 
or tissue injury, electromagnetic interference, tissue necrosis and 
burn, and thermal injury from implanted leads and implanted systems. 
The output characteristics and the methods used to determine these 
characteristics, including the following, must be determined:
     Peak output power;
     Pulse width;
     Pulse frequency;
     Duty cycle;
     Characteristics of other types of modulation that may be 
used;
     Average measured output powered into the RF antenna/
applicator;
     Specific absorption rates in saline gel test load;
     Characterization of the electrical and magnetic fields in 
saline gel test load for each RF antenna and prescribed RF antenna 
orientation/position; and
     Characterization of the deposited energy density in saline 
gel test load.
    4. Documented clinical performance testing must demonstrate safe 
and effective use of the device. This requirement would mitigate 
ineffective treatment.
    5. The labeling must include a detailed summary of the clinical 
testing pertinent to the use of the device and a summary of the adverse 
events and complications. This requirement would help mitigate the risk 
of adverse pregnancy outcome, risk to children, thermal injury from 
implanted leads and implanted systems with leads, electromagnetic 
interference, electric shock, tissue necrosis and burn, adverse tissue 
reaction, and ineffective treatment.
    Table 1 shows how FDA believes that the risks to health identified 
in Section V can be mitigated by the proposed special controls.

    Table 1--Health Risks and Mitigation Measures for Nonthermal SWT
------------------------------------------------------------------------
          Identified Risk                    Mitigation Measure
------------------------------------------------------------------------
Cellular or tissue injury.........  Non-clinical characterization and
                                     performance testing.
Electromagnetic interference......  Electromagnetic compatibility
                                     testing.
                                    Non-clinical characterization and
                                     performance testing.
                                    Labeling.
Tissue necrosis (tissue death) and  Non-clinical characterization and
 burns.                              performance testing.
                                    Electrical Safety Testing.
                                    Labeling.
Electrical shock..................  Electrical safety testing.
                                    Labeling.
Thermal injury from implanted       Non-clinical characterization and
 leads and implanted systems with    performance testing.
 leads.                             Labeling.
Adverse tissue reaction...........  Biocompatibility.
                                    Labeling.
Adverse pregnancy outcome.........  Labeling.
Risk to children..................  Labeling.
Ineffective treatment.............  Clinical performance data.
                                    Labeling.
------------------------------------------------------------------------

    In addition, under 21 CFR 801.109, the sale, distribution, and use 
of these devices are restricted to prescription use. Prescription use 
restrictions are a type of general controls in section 513(a)(1)(A)(i) 
of the FD&C Act. Also,

[[Page 9676]]

under 21 CFR 807.81, the device would continue to be subject to 510(k) 
notification requirements.

IX. 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.

X. Paperwork Reduction Act of 1995

    This proposed order refers to currently approved collections of 
information found in 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 part 807, subpart E, have been approved 
under OMB control number 0910-0120; the collections of information in 
21 CFR part 814, subpart B, have been approved under OMB control number 
0910-0231; and the collections of information under 21 CFR part 801 
have been approved under OMB control number 0910-0485.
    No burden shift is associated with the reclassification of the 
device. This is currently a class III device for which manufacturers 
must submit a premarket notification (510(k)). This order proposes to 
reclassify the device into class II, therefore, respondents would 
continue to submit a premarket notification.

XI. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act 
provided for FDA to issue regulations to reclassify devices. Although 
section 513(e) of the FD&C Act as amended requires FDA to issue final 
orders rather than regulations, FDASIA also provides for FDA to revoke 
previously issued regulations by order. FDA will continue to codify 
classifications and reclassifications in the Code of Federal 
Regulations (CFR). Changes resulting from final orders will appear in 
the CFR as changes to codified classification determinations or as 
newly codified orders. Therefore, under section 513(e)(1)(A)(i), as 
amended by FDASIA, in this proposed order we are proposing to revoke 
the requirements in Sec.  890.5290(b)(1) related to the classification 
of shortwave diathermy devices for all other uses as class III devices 
and to codify the reclassification of nonthermal SWT devices into class 
II (special controls).

XII. Proposed Effective Date

    FDA is proposing that any final order based on this proposed order 
become effective on the date of its publication in the Federal Register 
or at a later date if stated in the final order. FDA proposes that 
nonthermal SWT devices must comply with the special controls and must 
submit a 510(k) within 60 days after the effective date of the final 
order. FDA requests comment on whether 60 days is an appropriate time 
to allow manufacturers to prepare and submit 510(k)'s for these 
devices.

XIII. Comments

    Comments submitted to the previous docket (Docket No. FDA-2012-N-
0378) have been officially noted and do not need to be resubmitted. FDA 
has considered previous docket comments before issuing this proposed 
order. Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XIV. References

    The following references have 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 addresses, 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.
2. 47 CFR Part 18--Industrial, Scientific, And Medical Equipment, 
Subpart C, Sec.  18.301 is available at http://www.gpo.gov/fdsys/pkg/CFR-2009-title47-vol1/xml/CFR-2009-title47-vol1-part18.xml.
3. Executive Summary of the Orthopedic and Rehabilitation Devices 
Panel meeting is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq., as amended) and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that 21 CFR part 890 be 
amended as follows:

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. Section 890.5290 is amended by revising paragraphs (a)(1) and (b), 
and removing paragraph (c) to read as follows:

Sec.  890.5290  Shortwave diathermy.

    (a) Shortwave diathermy for use in applying therapeutic deep heat 
for selected medical conditions--(1) Identification. A shortwave 
diathermy for use in applying therapeutic deep heat for selected 
medical conditions is a device that applies to specific areas of the 
body electromagnetic energy in the radiofrequency (RF) bands of 13.56 
megahertz or 27.12 megahertz and that is intended to generate deep heat 
within body tissues for the treatment of selected medical conditions 
such as relief of pain, muscle spasms, and joint contractures, but not 
for the treatment of malignancies.
    (2) * * *
    (b) Nonthermal shortwave therapy--(1) Identification. A nonthermal 
shortwave therapy is a prescription device that applies to the body 
pulsed electromagentic energy in the RF bands of 13.56 megahertz or 
27.12 megahertz and that is intended for the treatment of medical 
conditions except for the treatment of malignancies by means other than 
the generation of deep heat within body tissues as described in 
paragraph (a) of this section.
    (2) Class II (special controls). The device is classified as Class 
II. The special controls for this device are:
    (i) Components of the device that come into human contact must be 
demonstrated to be biocompatible;
    (ii) Appropriate analysis/testing must demonstrate that the device 
is electrically safe and electromagnetically compatible in its intended 
use environment;
    (iii) Non-clinical performance testing must demonstrate that the 
device

[[Page 9677]]

performs as intended under anticipated conditions of use. Non-clinical 
performance testing must characterize the output waveform of the device 
and demonstrate that the device meets appropriate output performance 
specifications. The output characteristics and the methods used to 
determine these characteristics, including the following, must be 
determined:
    (A) Peak output power;
    (B) pulse width;
    (C) pulse frequency;
    (D) duty cycle;
    (E) characteristics of other types of modulation that may be used;
    (F) average measured output powered into the RF antenna/applicator;
    (G) specific absorption rates in saline gel test load;
    (H) characterization of the electrical and magnetic fields in 
saline gel test load for each RF antenna and prescribed RF antenna 
orientation/position; and
    (I) characterization of the deposited energy density in saline gel 
test load.
    (iv) Documented clinical performance testing must demonstrate safe 
and effective use of the device.
    (v) Labeling must include a detailed summary of the clinical 
testing pertinent to the use of the device and a summary of the adverse 
events and complications.

    Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03594 Filed 2-19-14; 8:45 am]
BILLING CODE 4160-01-P