[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Proposed Rules]
[Pages 39953-39959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16487]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 77, No. 130 / Friday, July 6, 2012 / Proposed 
Rules  

[[Page 39953]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

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


Effective Date of Requirement for Premarket Approval for 
Shortwave Diathermy for All Other Uses

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing 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 
preamendments device, shortwave diathermy (SWD) for all other uses. 
This device applies to the body electromagnetic energy in the radio 
frequency bands of 13 megahertz to 27.12 megahertz and is intended for 
the treatment of medical conditions by means other than the generation 
of deep heat within body tissues. It is not intended for treatment of 
malignancies. The Agency is also summarizing 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 is announcing the opportunity for 
interested persons to request that the Agency change the classification 
of any of the aforementioned devices based on new information. This 
action implements certain statutory requirements.

DATES: Submit either electronic or written comments by October 4, 2012. 
Submit requests for a change in classification by July 23, 2012. FDA 
intends that, if a final rule based on this proposed rule is issued, 
anyone who wishes to continue to market the device will need to submit 
a PMA or a notice of completion of a PDP within 90 days of the 
effective date of the final rule. Please see section XII of this 
document for the proposed effective date of any final rule that may 
publish based on this proposal.

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 ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper or CD-ROM 
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: Michael J. Ryan, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 1615, Silver Spring, MD 20993, 301-796-
6283.

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 (the SMDA) (Pub. L. 101-
629), and the Food and Drug Administration Modernization Act of 1997 
(FDAMA) (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), and the Food and Drug 
Administration Amendments Act of 2007 (Pub. L. 110-85), establish 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 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).
    A preamendments device that has been classified into class III may 
be marketed by means of premarket

[[Page 39954]]

notification procedures (510(k) process) without submission of a PMA 
until FDA issues a final regulation under section 515(b) of the FD&C 
Act (21 U.S.C. 360e(b)) requiring premarket approval. Section 515(b)(1) 
of the FD&C Act establishes the requirement that a preamendments device 
that FDA has classified into class III is subject to premarket 
approval. A preamendments class III device may be commercially 
distributed without an approved PMA or a notice of completion of a PDP 
until 90 days after FDA issues a final rule requiring premarket 
approval for the device, or 30 months after final classification of the 
device under section 513 of the FD&C Act, whichever is later. Also, a 
preamendments device subject to the rulemaking procedure under section 
515(b) of the FD&C Act is not required to have an approved 
investigational device exemption (IDE) (see part 812 (21 CFR part 812)) 
contemporaneous with its interstate distribution until the date 
identified by FDA in the final rule requiring the submission of a PMA 
for the device. At that time, an IDE is required only if a PMA has not 
been submitted or a PDP completed.
    Section 515(b)(2)(A) of the FD&C Act provides that a proceeding to 
issue a final rule to require premarket approval shall be initiated by 
publication of a notice of proposed rulemaking containing the following 
information: (1) The regulation, (2) proposed findings with respect to 
the degree of risk of illness or injury designed to be eliminated or 
reduced by requiring the device to have an approved PMA or a declared 
completed PDP and the benefit to the public from the use of the device, 
(3) an opportunity for the submission of comments on the proposed rule 
and the proposed findings, and (4) an opportunity to request a change 
in the classification of the device based on new information relevant 
to the classification of the device.
    Section 515(b)(2)(B) of the FD&C Act provides that if FDA receives 
a request for a change in the classification of the device within 15 
days of the publication of the notice, FDA shall, within 60 days of the 
publication of the notice, consult with the appropriate FDA advisory 
committee and publish a notice denying the request for change in 
reclassification or announcing its intent to initiate a proceeding to 
reclassify the device under section 513(e) of the FD&C Act. Section 
515(b)(3) of the FD&C Act provides that FDA shall, after the close of 
the comment period on the proposed rule and consideration of any 
comments received, issue a final rule to require premarket approval or 
publish a document terminating the proceeding together with the reasons 
for such termination. If FDA terminates the proceeding, FDA is required 
to initiate reclassification of the device under section 513(e) of the 
FD&C Act, unless the reason for termination is that the device is a 
banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
    If a proposed rule to require premarket approval for a 
preamendments device is finalized, section 501(f)(2)(B) of the FD&C Act 
(21 U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of 
a PDP for any such device be filed within 90 days of the date of 
issuance of the final rule or 30 months after the final classification 
of the device under section 513 of the FD&C Act, whichever is later. If 
a PMA or notice of completion of a PDP is not filed by the later of the 
two dates, commercial distribution of the device is required to cease 
since the device would be deemed adulterated under section 501(f) of 
the FD&C Act.
    The device may, however, be distributed for investigational use if 
the manufacturer, importer, or other sponsor of the device complies 
with the IDE regulations. If a PMA or notice of completion of a PDP is 
not filed by the later of the two dates, and the device does not comply 
with IDE regulations, the device is deemed to be adulterated within the 
meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure 
and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if 
its distribution continues. Shipment of devices in interstate commerce 
will be subject to injunction under section 302 of the FD&C Act (21 
U.S.C. 332), and the individuals responsible for such shipment will be 
subject to prosecution under section 303 of the FD&C Act (21 U.S.C. 
333). In the past, FDA has requested that manufacturers take action to 
prevent the further use of devices for which no PMA or PDP has been 
filed and may determine that such a request is appropriate for the 
class III devices that are the subjects of this regulation.
    The FD&C Act does not permit an extension of the 90-day period 
after issuance of a final rule within which an application or a notice 
is required to be filed. The House Report on the 1976 amendments states 
that: ``[T]he thirty month `grace period' afforded after classification 
of a device into class III * * * is sufficient time for manufacturers 
and importers to develop the data and conduct the investigations 
necessary to support an application for premarket approval.'' (H. Rept. 
94-853, 94th Cong., 2d sess. 42 (1976)).
    The SMDA added section 515(i) to the FD&C Act requiring FDA to 
review the classification of preamendments class III devices for which 
no final rule requiring the submission of PMAs has been issued, and to 
determine whether or not each device should be reclassified into class 
I or class II or remain in class III. For devices remaining in class 
III, the SMDA directed FDA to develop a schedule for issuing 
regulations to require premarket approval. The SMDA does not, however, 
prevent FDA from proceeding immediately to rulemaking under section 
515(b) of the FD&C Act on specific devices, in the interest of public 
health, independent of the procedures of section 515(i). Proceeding 
directly to rulemaking under section 515(b) of the FD&C Act is 
consistent with Congress' objective in enacting section 515(i), i.e., 
that preamendments class III devices for which PMAs have not been 
previously required either be reclassified to class I or class II or be 
subject to the requirements of premarket approval. Moreover, in this 
proposal, interested persons are being offered the opportunity to 
request reclassification of any of the devices.

II. Dates New Requirements Apply

    In accordance with section 515(b) of the FD&C Act, FDA is proposing 
to require that a PMA or a notice of completion of a PDP be filed with 
the Agency for class III devices within 90 days after issuance of any 
final rule based on this proposal. An applicant whose device was 
legally in commercial distribution before May 28, 1976, or whose device 
has been found to be substantially equivalent to such a device, will be 
permitted to continue marketing such class III devices during FDA's 
review of the PMA or notice of completion of the PDP. FDA intends to 
review any PMA for the device within 180 days, and any notice of 
completion of a PDP for the device within 90 days of the date of 
filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C 
Act, the Agency may not enter into an agreement to extend the review 
period for a PMA beyond 180 days unless the Agency finds that ``the 
continued availability of the device is necessary for the public 
health.''
    FDA intends that under Sec.  812.2(d), the preamble to any final 
rule based on this proposal will state that, as of the date on which 
the filing of a PMA or a notice of completion of a PDP is required to 
be filed, the exemptions from the requirements of the IDE regulations 
for preamendments class III devices in Sec.  812.2(c)(1) and (c)(2) 
will cease to apply to any device that is: (1) Not legally on the 
market on or before that

[[Page 39955]]

date, or (2) legally on the market on or before that date but for which 
a PMA or notice of completion of a PDP is not filed by that date, or 
for which PMA approval has been denied or withdrawn.
    If a PMA or notice of completion of a PDP for a class III device is 
not filed with FDA within 90 days after the date of issuance of any 
final rule requiring premarket approval for the device, commercial 
distribution of the device must cease. The device may be distributed 
for investigational use only if the requirements of the IDE regulations 
are met. The requirements for significant risk devices include 
submitting an IDE application to FDA for its review and approval. An 
approved IDE is required to be in effect before an investigation of the 
device may be initiated or continued under Sec.  812.30. FDA, 
therefore, cautions that IDE applications should be submitted to FDA at 
least 30 days before the end of the 90-day period after the issuance of 
the final rule to avoid interrupting investigations.

III. Proposed Findings With Respect to Risks and Benefits

    As required by section 515(b) of the FD&C Act, FDA is publishing 
its proposed findings regarding: (1) The degree of risk of illness or 
injury designed to be eliminated or reduced by requiring that these 
devices have an approved PMA or a declared completed PDP, and (2) the 
benefits to the public from the use of the devices.
    These findings are based on the reports and recommendations of the 
advisory committee (panel) for the classification of these devices 
along with information submitted in response to the 515(i) Order (74 FR 
16214, April 9, 2009), and any additional information that FDA has 
encountered. Additional information regarding the risks as well as 
classification associated with these device types can be found in the 
following proposed and final rules and notices published in the Federal 
Register: 44 FR 50512 (August 28, 1979), 48 FR 53032 (November 23, 
1983), and 52 FR 17732 (May 11, 1987).

IV. Devices Subject to This Proposal

Shortwave Diathermy for All Other Uses (21 CFR 890.5290(b))

1. Identification
    An SWD for all other uses except for the treatment of malignancies 
is a device that applies to the body electromagnetic energy in the 
radio frequency bands of 13 megahertz to 27.12 megahertz and that is 
intended for the treatment of medical conditions by means other than 
the generation of deep heat within body tissues as described in Sec.  
890.5290(a) (21 CFR 890.5290(a)).
2. Summary of Data
    The Agency first proposed classification of SWD devices for use in 
applying therapeutic deep heat as class II devices and SWD devices for 
any use other than applying therapeutic deep heat as class III devices 
in a proposed rule issued August 28, 1979 (44 FR 50512), based on 
recommendations made by the Physical Medicine Device Classification 
Panel of 1979 (The Physical Medicine Device Classification Panel). When 
a comment regarding the scope of the identifications for SWD devices in 
this proposed rule was received, the Agency asked the Physical Medicine 
Device Section of the Surgical and Rehabilitation Devices Panel (the 
Medicine Device Section) to review these devices in December 1979. 
Among their recommendations, the Medicine Device Section stated that to 
be therapeutically effective, a SWD device must be capable of providing 
energy sufficient to raise the temperature of tissues below the skin to 
44 [deg]C, and recommended that SWD devices be classified into class 
III when used in the treatment of malignancies because insufficient 
data exist concerning the safety and effectiveness of the device for 
this use (48 FR 53032). The Agency agreed with the Medicine Device 
Section that insufficient information existed to determine that general 
controls would provide reasonable assurance of the safety and 
effectiveness of the device when it was used for any purpose other than 
applying therapeutic deep heat, and that insufficient information 
existed to establish a performance standard to provide this assurance, 
and finalized its classification of SWD devices for all other uses 
except the treatment of malignancies by means other than the generation 
of deep heat as class III devices (52 FR 17732). Current peer-reviewed 
literature suggests several risks to health for these devices (see the 
following section of this document), and the Agency continues to 
believe that there is insufficient evidence and information to 
determine that general controls would provide reasonable assurance of 
the safety and effectiveness or to establish a performance standard or 
special controls to provide this assurance.
3. Risks to Health
    The Physical Medicine Device Classification Panel identified the 
following risks to health from all SWD devices: (1) Cellular or tissue 
injury, (2) pacemaker interference, (3) tissue necrosis (death) and 
burns, and (4) electrical shock. The Agency believes that these risks 
to health apply to SWD devices for all uses, and has also identified 
additional risks to health through review of peer-reviewed research and 
adverse event information. The Agency believes the following risks to 
health apply to SWD devices for all other uses.
     Cellular or Tissue Injury: There is uncertainty concerning 
the effects of electromagnetic flux on human cellular or tissue 
structures and functions. The cellular or tissue alterations may be 
induced by electromagnetic fields. The potential for and the effects of 
cellular changes by the electromagnetic field of the SWD device require 
further clinical study to show that the magnetic fields do not produce 
harmful effects on the cells.
     Pacemaker Interference: Several researchers have 
identified that the use of both thermal and nonthermal SWD can 
interfere with pacemaker function (Refs. 1 and 2). Electromagnetic 
fields generated by thermal and nonthermal SWD may interfere with the 
circuitry of a cardiac pacemaker or implantable defibrillator, which 
can lead to increased or decreased pacing rate, total loss of pacing, 
and/or cessation of pacemaker impulses.
     Tissue Necrosis (Death) and Cutaneous Burns: Excessive 
energy deposition into the tissue may cause excessive heating that 
results in tissue damage. In addition, a September 2011 review of 
Medical Device Reporting (MDR) and Manufacturer and User Facility 
Device Experience (MAUDE) databases identified two cases of burns 
associated with nonthermal SWD. Even though the therapeutic effect of 
nonthermal SWD appear to be nonthermal in mechanism, research has 
demonstrated that such devices do have a thermal effect and a direct 
correlation between pulse rate and thermal sensation exists (Refs. 3 
and 4).
     Electrical Shock: Excessive leakage current could result 
in injury, or a malfunction of the device could result in electrical 
shock.
     Thermal Injury from Implanted Wire Leads and Metal 
Implants: Studies have shown that SWD can cause heating of implanted 
wire leads and presents the risk of thermal injury to patients with 
implanted wire leads (Refs. 5 and 6).
    In a March 2003 public health notification (Ref. 7), FDA 
specifically warned that the danger of thermal injury can occur even 
when the SWD device is in non-heating mode, when the implanted device 
is not turned on, or when the implant has been removed

[[Page 39956]]

from the patient's body with the metal leads left behind.
     Radiation Hazards: Several researchers have expressed 
concern about the potential hazard from stray radiation and unintended 
exposure of the therapist or of non-treated areas of the patient (Refs. 
8, 9, and 10). The majority of SWD units in clinical use do not have 
shielded leads to transmit the high frequency generated to the 
applicator. Most SWD units have no provision to minimize radiation loss 
from the applicator in directions away from the patient. Hence, if the 
user or operator stays near the energized SWD unit and treat several 
patients daily, he or she could absorb significant electric and 
magnetic field radiation (Ref. 8). The International Commission on Non-
ionizing Radiation Protection has established limits to reduce radio 
frequency exposure in workers and the general public. Shields et al. 
(Ref. 9) studied stray electric and magnetic field strengths from 10 
SWD units. Findings demonstrated that, under a worst-case scenario, 
emissions from SWD exceed the guidelines for operators at distances 
currently recommended as safe.
     Abnormal Cell Growth: Cellular proliferation caused by 
nonthermal SWD in human and rat cell lines has been reported in in 
vitro studies (Ref. 11).

V. PMA Requirements

    A PMA for this device must include the information required by 
section 515(c)(1) of the FD&C Act. Such a PMA should also include a 
detailed discussion of the risks identified previously, as well as a 
discussion of the effectiveness of the device for which premarket 
approval is sought. In addition, a PMA must include all data and 
information on the following: (1) Any risks known, or that should be 
reasonably known, to the applicant that have not been identified in 
this document; (2) the effectiveness of the device that is the subject 
of the application; and (3) full reports of all preclinical and 
clinical information from investigations on the safety and 
effectiveness of the device for which premarket approval is sought.
    A PMA must include valid scientific evidence to demonstrate 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see Sec.  860.7(c)(2) (21 CFR 860.7(c)(2))). Valid 
scientific evidence is ``evidence from well-controlled investigations, 
partially controlled studies, studies and objective trials without 
matched controls, well-documented case histories conducted by qualified 
experts, and reports of significant human experience with a marketed 
device, from which it can fairly and responsibly be concluded by 
qualified experts that there is reasonable assurance of the safety and 
effectiveness of a device under its conditions of use. * * * Isolated 
case reports, random experience, reports lacking sufficient details to 
permit scientific evaluation, and unsubstantiated opinions are not 
regarded as valid scientific evidence to show safety or 
effectiveness.'' (Sec.  860.7(c)(2)).

VI. PDP Requirements

    A PDP for any of these devices may be submitted in lieu of a PMA, 
and must follow the procedures outlined in section 515(f) of the FD&C 
Act. A PDP must provide: (1) A description of the device, (2) 
preclinical trial information (if any), (3) clinical trial information 
(if any), (4) a description of the manufacturing and processing of the 
devices, (5) the labeling of the device, and (6) all other relevant 
information about the device. In addition, the PDP must include 
progress reports and records of the trials conducted under the protocol 
on the safety and effectiveness of the device for which the completed 
PDP is sought.

VII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA or notice of completion of a 
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through 
(b)(2)(A)(iv) of the FD&C Act and 21 CFR 860.132 to provide an 
opportunity for interested persons to request a change in the 
classification of the device based on new information relevant to the 
classification. Any proceeding to reclassify the device will be under 
the authority of section 513(e) of the FD&C Act.
    A request for a change in the classification of these devices is to 
be in the form of a reclassification petition containing the 
information required by Sec.  860.123 (21 CFR 860.123), including new 
information relevant to the classification of the device.
    The Agency advises that to ensure timely filing of any such 
petition, any request should be submitted to the Division of Dockets 
Management (see ADDRESSES) and not to the address provided in Sec.  
860.123(b)(1). If a timely request for a change in the classification 
of these devices is submitted, the Agency will, within 60 days after 
receipt of the petition, and after consultation with the appropriate 
FDA resources, publish an order in the Federal Register that either 
denies the request or gives notice of its intent to initiate a change 
in the classification of the device in accordance with section 513(e) 
of the FD&C Act and 21 CFR 860.130 of the regulations.

VIII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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.

IX. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this proposed rule is not a 
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The Agency believes that the final rule will have a 
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $139 million, using the most current (2011) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
rule to result in any 1-year expenditure that would meet or exceed this 
amount.

A. Need for Regulation

    The SWD devices that would be affected by this rule use 
electromagnetic energy in radio frequency bands to treat medical 
conditions other than malignancies through means other than heat. The 
devices are regulated under

[[Page 39957]]

Sec.  890.5290(b). These are currently class III preamendments devices 
and can be approved through premarket notification (510(k)) submissions 
rather than costlier PMA or PDP applications. Devices cleared through 
510(k) submissions may be subject to general and special controls 
designed to provide reasonable assurance of safety and effectiveness. 
FDA has determined that insufficient information exists to develop such 
controls for these devices and therefore the devices should be approved 
through PMA or PDP applications.
    Health care providers and patients rely on FDA determinations of 
safety and effectiveness when making treatment decisions. An FDA 
finding that current premarket requirements are inadequate to establish 
safety and effectiveness implies that health care providers and 
patients have inadequate information on these devices. We expect that 
at least some health care providers and patients who would have used 
these devices will make different consumption decisions if they possess 
more information.
    This proposed rule, should it be issued as a final rule, would 
require manufacturers of affected devices to file a PMA or a notice of 
completion of a PDP within 90 days. Under section 501 of the FD&C Act, 
a PMA or a notice of completion of a PDP must be filed either within 90 
days of the issuance of the final rule or within 30 months after the 
final classification of the device under section 513 of the FD&C Act, 
whichever is later. Because the final classification of SWD devices 
occurred in 1983, the 30-month period has elapsed. If a manufacturer 
failed to file a PMA or a notice of completion of a PDP within 90 days 
of the issuance of the final rule, the device would be deemed 
adulterated under section 501 of the FD&C Act.

B. Benefits

    The primary benefit of this rule would be the more efficient 
allocation of resources. We believe that health care providers and 
patients currently have incomplete information concerning the safety 
and effectiveness of these devices. This lack of information causes 
them to direct resources toward treatments they would not otherwise 
choose. Even extensive use of a medical product by physicians may not 
provide physicians with enough information to determine the safety and 
effectiveness of that product (Ref. 12).
    FDA has determined that the devices regulated by Sec.  890.5290(b) 
have not been shown to be safe and effective. Approval of a device 
through PMA procedures or PDP applications would require that safety 
and effectiveness be demonstrated. This demonstration of safety and 
effectiveness would increase the information available to health care 
providers and patients and enable them to allocate resources more 
efficiently. For example, this rule may improve the health of patients 
by causing resources to be redirected toward more effective treatment.
    FDA has insufficient data to estimate the size of the benefits from 
requiring PMA or PDP applications. The size of the benefits would vary 
with changes in the safety and effectiveness of treatment received as 
well as changes in the cost of treatment. Little information is 
available concerning the effectiveness of these devices, making 
estimation of the changes in the effectiveness of treatment received 
difficult.
    FDA does not expect the rule to result in large improvements in the 
safety of treatment received. FDA's MAUDE database records adverse 
events associated with medical devices. Few adverse events have been 
reported for the devices that would be affected by the rule.

C. Costs

    This rule would require the manufacturers of affected devices to 
prepare and submit PMAs. PMA approval procedures are substantially more 
costly than 510(k) clearance procedures. Furthermore, those 
manufacturers of devices already cleared through 510(k) submissions 
would be required to incur the additional costs of preparing and 
submitting PMAs to continue marketing their devices.
    The primary cost of preparing and submitting a PMA is typically the 
cost of clinical trials that demonstrate the safety and effectiveness 
of a device. These clinical trials typically cost between $10,000 and 
$20,000 per patient (Refs. 13 and 14). FDA estimates that the clinical 
trials necessary to demonstrate the safety and effectiveness of these 
devices would include between 50 and 150 patients. We therefore 
estimate that the clinical trials would cost between about $500,000 and 
$3 million per PMA.
    In addition to the cost of conducting the clinical trials, 
manufacturers would incur the cost of completing and submitting the 
applications. We estimate that the total cost of completing and 
submitting an application is between 25 and 35 percent of the cost of 
the clinical trials (Ref. 15).
    Additional costs would be incurred by FDA in reviewing any PMAs. 
The average cost of reviewing a PMA is estimated to be over $600,000 
(Ref. 16). Part of the cost of review would be borne by manufacturers 
through user fees. For fiscal year 2011, the PMA user fee was typically 
$236,298 for large firms and $59,075 for small firms (75 FR 45641, 
August 3, 2010).
    The total cost per PMA is therefore estimated to be between about 
$1.2 million and $4.7 million, with a primary estimate of $2.6 million. 
Not all of that cost would be a net social cost, however. A portion of 
the cost would be incurred as a result of the provision of additional 
medical care to clinical trial participants and therefore would be a 
transfer from manufacturers to health care providers or patients rather 
than a cost to society.
    We are uncertain about the number of PMAs that would be submitted. 
A manufacturer's decision to submit a PMA for a currently marketed 
device would involve considering the cost of the PMA, the probability 
of the PMA's approval, and the profits that would be lost were the 
device to be withdrawn from the market. We are unaware of data for 
these devices that would enable us to estimate the potential loss in 
profits from withdrawal. While the potential loss in profits would 
affect the decisions of manufacturers, lost profits would not generally 
be net social costs. Health care providers and patients would direct 
their financial resources elsewhere, resulting in additional profits, 
consumption or savings for other entities that would offset the lost 
profits for manufacturers of affected devices.
    FDA expects to receive one or fewer PMAs for affected devices 
should a final rule be issued. If one PMA were to be submitted, the 
total cost of preparing, submitting, and reviewing PMAs as a result of 
this rule would be between about $1.2 million and about $4.7 million, 
with a primary estimate of about $2.6 million.

D. Regulatory Flexibility Analysis

    Firms involved in the manufacture of medical devices are required 
to register with FDA and list the devices that they produce. FDA's 
Establishment Registration & Device Listing database contains nine 
firms that registered with FDA in 2011 and listed devices that would be 
affected by this rule. Eight of those firms were based in the United 
States. The U.S. Small Business Administration (SBA) defines a business 
in the Surgical and Medical Instrument Manufacturing industry (NAICS 
code 339112) as small if it has 500 or fewer employees (Ref. 17). Seven 
of the eight domestic firms are small according to the SBA definition.
    It is anticipated that most of the devices manufactured by these 
firms

[[Page 39958]]

would cease to be marketed if a final version of this rule were issued. 
Any manufacturers that remained in this market or entered in the future 
would be required to incur the cost of about $2 million associated with 
preparing and submitting a PMA. Therefore, FDA predicts that this rule 
would have a significant economic impact on a substantial number of 
small firms. This analysis together with other sections of this 
document serve as the Initial Regulatory Flexibility Analysis.
    FDA has analyzed regulatory options that would provide regulatory 
relief for small business compared with this rule. The only viable 
alternatives to the proposed reclassification would be options 
involving the reclassification of affected devices from class III to 
class II accompanied by the implementation of general and special 
controls. The costs associated with reclassification to class II vary 
with the costs of complying with the special controls. The more 
extensive the special controls, the costlier would be the 
reclassification. FDA has not estimated the costs of various levels of 
stringency of special controls but all levels would be far less costly 
than the $2 million for a PMA.
    As stated elsewhere in this document, however, FDA has determined 
that it has insufficient information to implement adequate general and 
special controls. The Agency has concluded that this rule is necessary 
to provide a reasonable assurance that SWD devices marketed in the 
United States are safe and effective for their intended use.

X. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

XI. Paperwork Reduction Act of 1995

    This proposed rule 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 part 812 have been approved under OMB 
Control No. 0910-0078; the collections of information in part 807, 
subpart E have been approved under OMB Control No. 0910-0120; the 
collections of information in 21 CFR part 814, subpart B have been 
approved under OMB Control No. 0910-0231; and the collections of 
information under 21 CFR part 801 have been approved under OMB Control 
No. 0910-0485.

XII. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become 
effective on the date of publication in the Federal Register or at a 
later date if stated in the final rule.

XIII. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to submit 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.

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. 
(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. Irnich, W., J.M. de Bakker, and H.J. Bisping, ``Electromagnetic 
Interference in Implantable Pacemakers,'' Pacing and Clinical 
Electrophysiology, 1(1): p. 52-61, 1978.
2. Jones, S.L., ``Electromagnetic Field Interference and Cardiac 
Pacemakers,'' Physical Therapy, 56(9): p. 1013-1018, 1976.
3. Murray C.C., S. Kitchen, ``Effect of Pulse Repetition Rate on the 
Perception of Thermal Sensation With Pulsed Shortwave Diathermy,'' 
Physiotherapy Research International, 5(2): p. 73-84, 2000.
4. Erdman W.J., ``Peripheral Blood Flow Measurements During 
Application of Pulsed High-Frequency Currents,'' American Journal of 
Orthopedics, (8): p. 196-197, 1960.
5. Ruggera, P.S., et al., ``In Vitro Assessment of Tissue Heating 
Near Metallic Medical Implants by Exposure to Pulsed Radio Frequency 
Diathermy,'' Physics in Medicine and Biology, 48(17): p. 2919-2928, 
2003.
6. FDA Summary Minutes, Meeting of the Circulatory System Devices 
Advisory Panel, Center for Devices and Radiological Health, 
Gaithersburg Holiday Inn, Gaithersburg, MD, available at http://www.fda.gov/ohrms/dockets/ac/cdrh03.html, May 29, 2003.
7. FDA Patient Safety News, Show 13: ``Warning on Diathermy 
and Implanted Leads,'' available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/PSN/printer.cfm?id=22, March 2003.
8. Kloth, L., et al., ``Therapeutic Microwave and Shortwave 
Diathermy--A Review of Thermal Effectiveness, Safe Use, and State of 
the Art,'' HHS Publication FDA 85-8237, 1984.
9. Shields, N., N. O'Hare, and J. Gormley, ``An Evaluation of Safety 
Guidelines to Restrict Exposure to Stray Radiofrequency Radiation 
From Short-Wave Diathermy Units,'' Physics in Medicine and Biology, 
49(13): p. 2999-3015, 2004.
10. Martin, C.J., et al., ``An Evaluation of Radiofrequency Exposure 
From Therapeutic Diathermy Equipment in the Light of Current 
Recommendations,'' Clinical Physics and Physiological Measurement, 
11(1): p. 53-63, available at http://iopscience.iop.org/0143-0815/11/1/005, 1990.
11. George, F.R., R.J. Lukas, et al., ``In-vitro Mechanisms of Cell 
Proliferation Induction: A Novel Bioactive Treatment for 
Accelerating Wound Healing,'' Wounds, 14: p. 107-115, available at 
http://www.woundsresearch.com/article/300, 2002.
12. Elliott, Bennett-Guerrero, et al., ``Gentamicin-Collagen Sponge 
for Infection Prophylaxis in Colorectal Surgery,'' New England 
Journal of Medicine, 363, No. 11: 1038-1049, 2010.
13. Kaplan, Aaron V., et al., ``Medical Device Development: From 
Prototype to Regulatory Approval,'' Circulation, 109 No. 25: 3068-
3072, available at http://circ.ahajournals.org/content/109/25/3068.full, 2004.
14. Lionberger, Robert, ``FDA Critical Path Initiatives: 
Opportunities for Generic Drug Development,'' The AAPS Journal, 10, 
No. 1: 103-109, available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751455/, 2008.
15. Makower, Joshua, ``FDA Impact on US Medical Technology 
Innovation: A Survey of Over 200 Medical Technology Companies,'' 
available at http://www.medicaldevices.org, 2010.
16. Geiger, Dale R., ``FY 2003 and FY 2004 Unit Costs for the 
Process of Medical Device Review,'' available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109216.pdf.2005, 
September 2005.
17. U.S. Small Business Administration, ``Table of Small Business 
Size Standards Matched to North American Industry Classification 
System Codes,'' available at http://www.sba.gov/sites/default/files/Size_Standards_Table.pdf.

[[Page 39959]]

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, it is 
proposed that 21 CFR part 890 be amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

    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.

    2. Section 890.5290 is amended by revising paragraph (c) to read as 
follows:


Sec.  890.5290  Shortwave diathermy.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before [date 90 days after date of 
publication of the final rule in the Federal Register], for any 
shortwave diathermy for all other uses (as described in paragraph 
(b)(1) of this section) that was in commercial distribution before May 
28, 1976, or that has, on or before [date 90 days after date of 
publication of the final rule in the Federal Register], been found to 
be substantially equivalent to any shortwave diathermy for all other 
uses (as described in paragraph (b)(1) of this section) that was in 
commercial distribution before May 28, 1976. Any other shortwave 
diathermy for all other uses (as described in paragraph (b)(1) of this 
section) shall have an approved PMA or declared completed PDP in effect 
before being placed in commercial distribution.

    Dated: June 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-16487 Filed 7-5-12; 8:45 am]
BILLING CODE 4160-01-P