20 July 2011. Two notices.
Focused Ultrasound Stimulator System
[Federal Register Volume 76, Number 139 (Wednesday, July 20, 2011)]
[Rules and Regulations]
[Pages 43119-43121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18278]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2011-N-0499]
Medical Devices; General and Plastic Surgery Devices;
Classification of the Focused Ultrasound Stimulator System for
Aesthetic Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
focused ultrasound stimulator system for aesthetic use into class II
(special controls). The special control(s) that will apply to the
device is the guidance document entitled ``Class II Special Controls
Guidance Document: Focused Ultrasound Stimulator System for Aesthetic
Use.'' The Agency is classifying the device into class II (special
controls) in order to provide a reasonable assurance of safety and
effectiveness of the device.
DATES: This rule is effective August 19, 2011. The classification was
effective on September 11, 2009.
FOR FURTHER INFORMATION CONTACT: Richard Felten, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1436, Silver Spring, MD 20993-0002, 301-796-6392.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).
Section 513(f)(2) of the FD&C Act provides that any person who
submits a premarket notification under section 510(k) of the FD&C Act
for a device that has not previously been classified may, within 30
days after receiving an order classifying the device into class III
under section 513(f)(1) of the FD&C Act, request FDA to classify the
device under the criteria set forth in section 513(a)(1) of the FD&C
Act. FDA will, within 60 days of receiving this request, classify the
device by written order. This classification will be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing this classification.
In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on March 14, 2008 classifying the Ulthera\TM\ Focused Ultrasound
Stimulator System for Aesthetic Use into class III, because it was not
substantially equivalent to a device that was introduced or delivered
for introduction into interstate commerce for commercial distribution
before May 28, 1976, or a device which was subsequently reclassified
into class I or class II. On April 11, 2008, Ulthera, Inc. submitted a
petition requesting classification of the Ulthera\TM\ Focused
Ultrasound Stimulator System for Aesthetic Use under section 513(f)(2)
of the FD&C Act. The manufacturer recommended that the device be
classified into class II (Ref. 1).
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the petition in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls will provide reasonable
assurance of the safety and effectiveness of the device.
The device is assigned the generic name Focused Ultrasound
Stimulator System for Aesthetic Use and it is identified as a device
using focused ultrasound to produce localized, mechanical motion within
tissues and cells for the purpose of producing either localized heating
for tissue coagulation or for mechanical cellular membrane disruption
intended for noninvasive aesthetic use.
FDA has identified the following risks to health associated
specifically with this type of device and the recommended measures to
mitigate these risks.
Thermal injury from focused ultrasound exposure (thermal
damage), such as erythema, edema, pigmentary changes, and pain. These
are commonly seen risks associated with any energy delivery system that
creates tissue heating. This risk is addressed by recommended treatment
parameters that have been shown to be safe with little or no adverse
effects. In addition, the recommended labeling includes warnings
related to patient reaction in terms of pain and information to user in
terms of observable skin reactions that are known to be precursors to
the potential thermal adverse effects.
Mechanical injury from focused ultrasound exposure
(mechanical damage) induced by either cavitation or noncavitation
means. Notable effects are pain and petechial hemorrhage (red spots).
Further, skin contour changes due to scar formation are possible. This
risk is addressed by recommended treatment parameters that have been
shown to be safe with little or no adverse effects.
Ocular injury represents a potentially unique serious risk
from inadvertent ultrasound exposure. The mitigation of this risk is
addressed by labeling recommendations to warn the user not to expose
the eye to ultrasound radiation, as well as specific directions
intended to ensure complete handpiece skin contact, which further
reduces the risk of scattered ultrasound energy reaching the eye.
Electrical shock is addressed by recommended testing of
the device according to recognized U.S. and International Standards
specifically designed to determine and measure potential electrical
safety. Again, the recommended device labeling also includes specific
warnings for the user in terms of device placement, appropriate
electrical wiring needs, reminders to periodically check device wiring
and accessories for damage, and avoidance of use of the device in
[[Page 43120]]
environments where electrical shock is possible.
Inflammation/foreign body response relates to possible
issues that can occur following any type of therapeutic process in
which tissue injury could occur. This risk is typical for any surgical
procedure and is addressed by the recommendations to follow routine
standard of care for any surgical patient that could include
posttreatment skin care including use of moisturizers, antibacterial
creams, and avoidance of potential risks such as use of perfumes,
facial creams, and sunlight.
Use error represents those risks to the patient that can
occur from improper use of the device. In order to address this
potential risk, we recommend the manufacturer provide a detailed
operator manual which contains information on possible risks and
hazards and how these should be avoided and clear recommended safe
treatment procedures that include information on device settings for
treatment, clear information on how the device is to be used during
treatment, and recommended posttreatment care.
Table 1--Risks to Health and Mitigation Measures
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Identified risk Recommended mitigation measures
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Thermal Injury from Focused Ultrasound Section 6. Bench Testing.
Exposure (Thermal Damage). Section 7: Software Validation.
Section 8. Animal Testing.
Section 9. Clinical Testing.
Section 13. Labeling.
Mechanical Injury from Focused Section 6. Bench Testing.
Ultrasound Exposure (Cavitation or Section 7. Software Validation.
other Mechanical Damage). Section 8. Animal Testing.
Section 9. Clinical Testing.
Section 13. Labeling.
Ocular Injury.......................... Section 13. Labeling.
Electrical Shock....................... Section 12. Electrical and
Mechanical Safety Performance
Testing.
Inflammation/Foreign Body Response..... Section 10. Biocompatibility.
Use Error (Eye Injury)................. Section 13. Labeling.
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FDA believes that the special controls guidance document, ``Class
II Special Controls Guidance Document: Focused Ultrasound Stimulator
System for Aesthetic Use,'' in addition to general controls, addresses
the risks to health and provides reasonable assurance of the safety and
effectiveness of the device. Therefore, on September 11, 2009, FDA
issued an order to the petitioner classifying the device into class II.
FDA is codifying the classification of the device by adding Sec.
878.4590.
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for focused ultrasound
stimulator system for aesthetic use will need to address the issues
covered in the special controls guidance. However, the firm need only
show that its device meets the recommendations of the guidance or in
some other way provides equivalent assurance of safety and
effectiveness.
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 device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the focused ultrasound stimulator
system for aesthetic use they intend to market.
Elsewhere in this issue of the Federal Register, FDA is issuing a
notice announcing the availability of the guidance document entitled
``Class II Special Controls Guidance Document: Focused Ultrasound
Stimulator System for Aesthetic Use'' that will serve as the special
control for this device.
II. Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
III. Analysis of Impacts
FDA has examined the impacts of the final 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 final 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. Because reclassification of this device from class
III to class II will relieve manufacturers of the device of the cost of
complying with the premarket approval requirements of section 515 of
the FD&C Act (21 U.S.C. 360e), and may permit small potential
competitors to enter the marketplace by lowering their costs, the
Agency certifies that the final rule will not 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 $136 million, using the most current (2010) Implicit
Price Deflator for the Gross
[[Page 43121]]
Domestic Product. FDA does not expect this final rule to result in any
1-year expenditure that would meet or exceed this amount.
IV. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires Agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain state requirements ``different from or in
addition to'' certain federal requirements applicable to devices. 21
U.S.C. 360k; See Medtronic Inc., v. Lohr, 518 U.S. 470 (1996); and
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The special controls
established by this final rule create ``requirements'' for specific
medical devices under 21 U.S.C. 360k, even though product sponsors have
some flexibility in how they meet those requirements. Cf. Papike v.
Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1991).
V. Paperwork Reduction Act of 1995
FDA concludes that this final rule contains no new collections of
information. Therefore, clearance by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3520) is not required. This final rule establishes as special
controls a guidance document that refers to previously approved
collections of information found in other FDA regulations. These
collections of information are subject to review by OMB under the PRA.
VI. References
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Petition from Ulthera, Inc., April 11, 2008.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Section 878.4590 is added to subpart E to read as follows:
Sec. 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a) Identification. A Focused Ultrasound Stimulator System for
Aesthetic Use is a device using focused ultrasound to produce
localized, mechanical motion within tissues and cells for the purpose
of producing either localized heating for tissue coagulation or for
mechanical cellular membrane disruption intended for noninvasive
aesthetic use.
(b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' See
Sec. 878.1(e) for the availability of this guidance document.
Dated: July 15, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18278 Filed 7-19-11; 8:45 am]
BILLING CODE 4160-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0500]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Focused Ultrasound
Stimulator System for Aesthetic Use; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled, ``Class II Special Controls
Guidance Document: Focused Ultrasound Stimulator System for Aesthetic
Use.'' This guidance document describes a means by which focused
ultrasound stimulator systems for aesthetic use may comply with the
requirement of special controls for class II devices. This guidance
document is being immediately implemented as the special control for
focused ultrasound stimulator systems for aesthetic use, but it remains
subject to comment in accordance with the Agency's good guidance
practices.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance are welcome at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document:
Focused Ultrasound Stimulator System for Aesthetic Use'' to the
Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the guidance to http://www.regulations.
gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Richard Felten, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1436, Silver Spring, MD 20993-0002, 301-796-6392.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document will serve as the special control for
focused ultrasound stimulator systems for aesthetic use. Section
513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360c(f)(2)) provides that any person who submits a premarket
notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k))
for a device that has not previously been classified may, within 30
days after receiving an order classifying the device in class III under
section 513(f)(1) of the FD&C Act, request FDA to classify the device
under the criteria set forth in section 513(a)(1) of the FD&C Act. FDA
shall, within 60
[[Page 43333]]
days of receiving such a request, classify the device by written order.
This classification shall be the initial classification of the device.
Within 30 days after the issuance of an order classifying the device,
FDA must publish a notice in the Federal Register announcing such
classification. Because of the timeframes established by section
513(f)(2) of the FD&C Act, FDA has determined, under 21 CFR
10.115(g)(2), that it is not feasible to allow for public participation
before issuing this guidance as a final guidance document. Thus, FDA is
issuing this guidance document as a level 1 guidance document that is
immediately in effect. FDA will consider any comments that are received
in response to this notice to determine whether to amend the guidance
document.
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying focused ultrasound stimulator systems for
aesthetic use into class II (special controls) under section 513(f)(2)
of the FD&C Act.
II. Significance of Guidance
FDA believes that adherence to the recommendations described in
this guidance document, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of focused
ultrasound stimulator system for aesthetic use classified under
878.4590 (21 CFR Part 878). In order to be classified as a class II
device under 878.4590, an ultrasound stimulator for aesthetic use must
comply with the requirements of special controls; a manufacturer must
address the issues requiring special controls as identified in the
guidance, either by following the recommendations in the guidance
document or by some other means that provides equivalent assurances of
safety and effectiveness.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Class II Special Controls Guidance Document: Focused Ultrasound
Stimulator System for Aesthetic Use,'' you may either send an e-mail
request to dsmica@fda.hhs.gov to receive an electronic copy of the
document or send a fax request to 301-847-8149 to receive a hard copy.
Please use the document number 1701 to identify the guidance you are
requesting
IV. Paperwork Reduction Act of 1995
This guidance 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 807, subpart E, have been
approved under OMB control number 0910-0120; 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 56.115 have
been approved under OMB control number 0910-0130; the collections of
information in 21 CFR 50.23 have been approved under OMB control number
0910-0586; the collections of information in 21 CFR Part 58 have been
approved under OMB control number 0910-0119; and the collections of
information in 21 CFR Part 801 have been approved under OMB control
number 0910-0485.
V. 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 send one set of comments. It is no
longer necessary to send two copies of mailed 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.
Dated: July 15, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18280 Filed 7-19-11; 8:45 am]
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