[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Rules and Regulations]
[Pages 61298-61302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25923]


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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; Reclassification of Shortwave 
Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal 
Shortwave Therapy

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; technical correction.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
order to reclassify 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 
also making a technical correction in the regulation for the carrier 
frequency for SWD and SWT devices.

DATES: This order is effective on October 13, 2015. See further 
discussion in Section IV, ``Implementation Strategy.''

FOR FURTHER INFORMATION CONTACT: Michael J. Ryan, Center for Devices 
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, 
Silver Spring, MD 20993, 301-796-6283, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the 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

[[Page 61299]]

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 (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), among other amendments, 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).
    Under section 513(d) 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 21 CFR part 807.
    A preamendments device that has been classified into class III and 
devices found substantially equivalent by means of premarket 
notification (510(k)) procedures to such a preamendments device or to a 
device within that type (both the preamendments and substantially 
equivalent devices are referred to as preamendments class III devices) 
may be marketed without submission of a premarket approval application 
(PMA) until FDA issues a final order under section 515(b) of the FD&C 
Act (21 U.S.C. 360e(b)) requiring premarket approval.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA 
amended section 513(e) of the FD&C Act, changing the mechanism for 
reclassifying a device from rulemaking to an administrative order.
    Section 513(e) of the FD&C Act provides that FDA may, by 
administrative order, reclassify a device based upon ``new 
information.'' FDA can initiate a reclassification under section 513(e) 
or an interested person may petition FDA to reclassify a preamendments 
device. The term ``new information,'' as used in section 513(e), 
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 Co. 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 action where the reevaluation is made 
in light of newly available authority (see Bell, 366 F.2d at 181; 
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991); or, in 
light of changes in ``medical science,'' Upjohn, 422 F.2d at 951). 
Whether data before the Agency are old or new data, the ``new 
information'' to support reclassification under section 513(e) must be 
``valid scientific evidence'' as defined in section 513(a)(3) of the 
FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., Gen. Medical Co. v. FDA, 
770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Ass'n v. FDA, 766 
F.2d 592 (D.C. Cir. 1985), 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 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. 
FDA published a proposed order to reclassify this device in the Federal 
Register of February 20, 2014 (79 FR 9671). FDA has held a meeting of a 
device classification panel described in section 513(b) of the FD&C Act 
to discuss shortwave diathermy for all other uses, and therefore, has 
met this requirement under section 513(e)(1) of the FD&C Act. As 
explained further in section II of the proposed order, a meeting of a 
device classification panel described in section 513(b) of the FD&C Act 
took place on May 21, 2013. FDA received and has considered several 
comments on this proposed order, as discussed in Section II.

II. Public Comments in Response to the Proposed Order

    In response to the February 20, 2014, proposed order to reclassify 
shortwave diathermy for all other uses and to rename the device 
``nonthermal shortwave therapy,'' FDA received 40 comments from 
industry, a patient advocacy group, and consumers of SWT devices. Of 
those, 35 comments were received from users of specific devices who 
support the use and availability of those devices in the United States. 
Several of these comments also supported reclassification into class 
II. This final order reclassifies into class II SWT devices intended 
for adjunctive use in the palliative treatment of postoperative pain 
and edema of soft tissue by means other than the generation of deep 
heat within body tissues and establishes special controls that are 
intended to mitigate risks to health of SWT devices in order to provide 
a reasonable assurance of their safety and effectiveness. These special 
controls are meant to protect patients from unsafe or ineffective SWT 
devices.
    Six of the comments from users also requested that the prescription 
use restriction be removed from the proposed regulation so that SWT 
devices could be available over-the-counter (OTC). This final order 
applies only to SWT devices for the indications and uses that have been 
previously cleared for marketing. To date, FDA has not cleared an SWT 
device for OTC use and, as a result, has limited the reclassification 
in this final order to prescription use devices. However, if FDA 
receives a marketing application in the future for an SWT device 
indicated

[[Page 61300]]

for OTC use, FDA would make its classification decision regarding such 
use at that time.
    One public comment FDA received requested that SWT devices remain 
classified in class III, and that FDA call for PMAs. FDA disagrees that 
SWT devices should remain in class III and require PMA approval. On May 
21, 2013, FDA held a meeting of the Orthopedic and Rehabilitation 
Devices Panel (the 2013 Panel), to discuss the classification of SWT 
devices (Ref. 1). The 2013 Panel reached consensus that SWT devices did 
not fit the statutory definition of a class III device. Section 
513(a)(1)(C) of the FD&C Act provides that a device is class III if (a) 
the device is life supporting or life sustaining, of substantial 
importance in preventing impairment to human health, or presents a 
potential unreasonable risk of illness or injury, and (b) the device 
cannot be classified in class I or II because insufficient information 
exists to determine that general controls or general and special 
controls would provide reasonable assurance of the safety and 
effectiveness of the device. The 2013 Panel agreed that SWT devices are 
not life supporting or life sustaining, or of substantial importance to 
preventing impairment to human health. The 2013 Panel was concerned 
about the potential unreasonable risk of illness or injury resulting 
from the use of SWT devices in certain instances, such as treatments 
around the eye. Moreover, the 2013 Panel concluded that the information 
presented to the panel was sufficient to establish special controls 
that are necessary to provide reasonable assurance of safety and 
effectiveness of SWT. Thus, the consensus of the 2013 Panel was to 
recommend that SWT be reclassified into class II (special controls).
    FDA agrees with the 2013 Panel's recommendation for 
reclassification. The Agency believes, as stated in the proposed order, 
that the risks of SWT devices are sufficiently understood based on 
valid scientific evidence, and a review of the clinical literature 
indicates that few relevant adverse events have been reported for these 
devices. FDA further believes that the risks of SWT devices with the 
special controls identified in this final order will be nominal.
    One of the public comments, received from industry, requested 
removal of the special control requiring clinical data, stating that it 
was unnecessary and there was already sufficient evidence of 
effectiveness. This comment did not cite new data, but requested that 
FDA reconsider the data that was previously presented to the 2013 
Panel. The available scientific evidence on the effectiveness of SWT 
was presented to the 2013 Panel by both FDA and industry, and there was 
panel consensus that the existing data was very limited and that 
clinical data should be required as a special control. When asked to 
consider the benefits of SWT based on the information presented to it 
by FDA and industry, the 2013 Panel consensus was that there may be a 
certain subset of patients who may benefit from SWT; however, the 2013 
Panel had ``very serious concerns involving both the veracity and the 
scientific methodology of the data presented.'' Thus, although the 
limited data reviewed by the Agency and by the 2013 Panel suggest that 
SWT could potentially be effective, particularly for management of 
postoperative pain, the 2013 Panel members indicated a need for 
clinical data demonstrating effectiveness from statistically powered, 
well-controlled studies with quantified outcomes. The 2013 Panel agreed 
with FDA that clinical studies should consider the following 
attributes: Randomization, utilization of sham controls, blinding, 
well-defined cohorts, well-defined treatment parameters, clinically 
relevant and validated measures, adequate power, appropriate and 
defined methods of statistics, predefined hypotheses, and systematic 
collection of adverse events. The 2013 Panel believed that clinical 
studies incorporating these basic design elements should be feasible to 
conduct, and are important in demonstrating an appropriate level of 
effectiveness for specific devices. FDA agrees with the 2013 Panel's 
assessment and has determined that the special controls identified in 
this final order, including clinical performance data, are necessary to 
provide a reasonable assurance of safety and effectiveness of SWT.
    Two comments from sponsors of currently marketed SWT devices 
supported reclassification, but requested 2 years from the effective 
date of the final order to submit a 510(k), rather than the 60 days FDA 
proposed in the proposed order. The comments suggested that if clinical 
data are necessary, it will be difficult to plan and conduct a clinical 
trial and submit the data within 60 days of the effective date of the 
final order. One comment suggested that it will be beneficial to 
interact with the Agency prior to a clinical trial and submission of 
the data to FDA, and that 60 days may not be adequate to accomplish 
such. FDA would like to encourage interaction with the Agency prior to 
a clinical study and submission of the data to FDA, and therefore 
grants these requests to provide more time for currently legally 
marketed SWT devices to comply with the special controls identified in 
this order. The special controls will be effective on the date of 
publication of this final order. However, FDA does not intend to 
enforce compliance with the special controls with respect to currently 
legally marketed SWT devices until 1 year after the date of publication 
of this final order. Please see Section IV, ``Implementation 
Strategy.'' The Agency also notes that when indicated for adjunctive 
use in the palliative treatment of postoperative pain and edema, SWT 
devices may not be considered significant risk devices, per 21 CFR 
812.3(m), and therefore clinical studies conducted in the United States 
involving SWT devices with those indications for use may not require an 
application for Investigational Device Exemption (U.S. studies 
involving such devices would, however, require approval by an 
institutional review board; see 21 CFR 812.2(b)(1)). Alternatively, SWT 
devices with indications for use different from adjunctive use in the 
palliative treatment of postoperative pain and edema of soft tissue, or 
that specify the types of postoperative pain or edema, may be 
considered significant risk devices. We encourage interaction with FDA 
through the presubmission process to address any questions regarding 
whether such a device is significant risk.
    One industry comment challenged FDA's authority to require new 
510(k)s for SWT devices that have already been legally marketed to 
demonstrate that the SWT devices meet the special controls. FDA has 
considered this comment, and will not require manufacturers of 
currently legally marketed SWT devices to submit a new 510(k) 
notification. However, manufacturers must comply with the special 
controls implemented by this order; if the special controls are not met 
then the device may be considered adulterated under section 
501(f)(1)(B) of the FD&C Act (21 U.S.C. 351(f)(1)(B). In order to 
ensure compliance with these special controls, FDA is requiring that 
manufacturers of currently marketed SWT devices submit an amendment to 
their previously cleared 510(k) demonstrating compliance with the 
special controls. Such amendment will be added to the 510(k) file but 
will not serve as a basis for a new substantial equivalence review. An 
amendment to a 510(k) in this context will be used solely to submit 
information demonstrating to

[[Page 61301]]

FDA that an SWT device is in compliance with the special controls.
    As discussed above, the special controls will be effective on the 
date of publication of this final order. However, FDA does not intend 
to enforce compliance with the special controls with respect to 
currently legally marketed SWT devices until 1 year after the date of 
publication. Please see Section IV, ``Implementation Strategy.'' If an 
amendment to a 510(k) that demonstrates compliance with the special 
controls for the device is not submitted as required in Section IV or 
if FDA determines after review of the amendment that the device is not 
in compliance with the special controls, the device may be considered 
adulterated and sale of the device would have to cease.
    In reviewing the proposed order, the comments received, and the 
2013 Panel's recommendations, FDA is also making a few modifications to 
the identification and special controls for SWT devices. The 
identification has been revised from ``intended for the treatment of 
medical conditions except for the treatment of malignancies'' to 
``intended for adjunctive use in the palliative treatment of 
postoperative pain and edema of soft tissue,'' as the latter statement 
more closely captures the current intended uses of existing SWT 
devices. The special control that specifies saline gel test loads has 
been revised to allow for testing in saline gel test load or other 
appropriate models to allow for flexible characterization approaches. 
The special control ``Documented clinical performance testing must 
demonstrate safe and effective use of the device'' has been revised to 
``A detailed summary of the clinical testing pertinent to use of the 
device to demonstrate the effectiveness of the device in its intended 
use.'' This revision clarifies the information that FDA would expect to 
see under this special control. Finally, labeling for SWT devices must 
include output characteristics of the device and recommended treatment 
regimes, including duration of use, in addition to a detailed summary 
of the clinical testing pertinent to the use of the device and a 
summary of the adverse events and complications. This revision 
clarifies the type of information that FDA would expect to see in 
labeling for SWT devices. FDA believes these revisions provide 
additional clarification and flexibility for SWT device manufacturers.

III. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings 
as published in the preamble to the proposed order with the 
modifications discussed in Section II of this final order. FDA is 
issuing this final order to reclassify shortwave diathermy (SWD) for 
adjunctive use in the palliative treatment of postoperative pain and 
edema in superficial soft tissue by means other than the generation of 
deep heat within body tissues from class III to class II, rename the 
device ``nonthermal shortwave therapy'' (SWT), and establish special 
controls by revising part 890 (21 CFR part 890). As described in the 
proposed order, FDA is also making a technical correction in the 
regulation for the carrier frequency for SWD and SWT devices from ``13 
megahertz (MHz) to 27.12 MHz'' to ``13.56 MHz or 27.12 MHz.'' The 
identification for Sec.  890.5290 has been revised to provide the name 
change of the device under paragraph (b) and a more accurate 
description of the devices in this classification section. SWT devices 
must comply with the special controls identified in this order (see 
Section IV, ``Implementation Strategy'').
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act if FDA determines that premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the devices. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of safety and 
effectiveness of SWT and, therefore, this device type is not exempt 
from premarket notification requirements.
    Following the effective date of this final order, firms marketing 
SWT devices must comply with the special controls set forth in this 
order (see Section IV, ``Implementation Strategy'').

IV. Implementation Strategy

    The special controls identified in this final order are effective 
October 13, 2015. For models of SWT devices that have not been legally 
marketed prior to October 13, 2015, or models that have been legally 
marketed but are required to submit a new 510(k) under Sec.  
807.81(a)(3) because the device is about to be significantly changed or 
modified, manufacturers must obtain 510(k) clearance, among other 
relevant requirements, and demonstrate compliance with the special 
controls included in this final order, before marketing the new or 
changed device.
    FDA does not intend to enforce compliance with the special controls 
for currently legally marketed SWT devices until October 13, 2016. For 
those manufacturers who wish to continue to offer currently legally 
marketed devices for sale, FDA expects them to submit a 510(k) 
amendment for those devices by October 13, 2016 demonstrating 
compliance with the special controls included in this final order. If a 
510(k) amendment is not submitted by this date for the device or if FDA 
determines that the amendment does not demonstrate compliance with the 
special controls, the device may be considered adulterated under 
section 501(f)(1)(B) of the FD&C Act as of the date of FDA's 
determination of noncompliance or October 13, 2016, whichever is 
sooner, and sale of the device would have to cease.

V. Environmental Impact, No Significant 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.

VI. Paperwork Reduction Act of 1995

    This final order refers to previously 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 21 CFR part 812 have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
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.

VII. 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) of the 
FD&C Act, as amended by FDASIA, in this final order

[[Page 61302]]

we are revoking the requirements in Sec.  890.5290(b) related to the 
classification of SWT as class III devices and codifying the 
reclassification of SWT into class II (special controls).

VIII. Reference

    FDA has placed the following reference on display in the Division 
of Dockets Management (HFA-305) Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. Interested persons may see 
it between 9 a.m. and 4 p.m., Monday through Friday, and online at 
http://www.regulations.gov.
    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.

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:

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).
    The revisions 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 (MHz) or 27.12 MHz 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.
* * * * *
    (b) Nonthermal shortwave therapy--(1) Identification. A nonthermal 
shortwave therapy is a prescription device that applies to the body 
pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz 
and that is intended for adjunctive use in the palliative treatment of 
postoperative pain and edema of soft tissue by means other than the 
generation of deep heat within body tissues as described in paragraph 
(a) of this section.
    (2) Classification: 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 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 or other 
appropriate model;
    (H) Characterization of the electrical and magnetic fields in 
saline gel test load or other appropriate model for each RF antenna and 
prescribed RF antenna orientation/position; and
    (I) Characterization of the deposited energy density in saline gel 
test load or other appropriate model.
    (iv) A detailed summary of the clinical testing pertinent to use of 
the device to demonstrate the effectiveness of the device in its 
intended use.
    (v) Labeling must include the following:
    (A) Output characteristics of the device;
    (B) Recommended treatment regimes, including duration of use; and
    (C) A detailed summary of the clinical testing pertinent to the use 
of the device and a summary of the adverse events and complications.
    (vi) Nonthermal shortwave therapy devices marketed prior to the 
effective date of this reclassification must submit an amendment to 
their previously cleared premarket notification (510(k)) demonstrating 
compliance with these special controls.

    Dated: October 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25923 Filed 10-9-15; 8:45 am]
BILLING CODE 4164-01-P