81 FR 42243 - Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 125 (June 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 125 (June 29, 2016)
| Page Range | 42243-42245 | |
| FR Document | 2016-15381 |
[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)] [Rules and Regulations] [Pages 42243-42245] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15381] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2016-N-1618] Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-counter aesthetic use's classification. 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 order is effective June 29, 2016. The classification was applicable on December 18, 2015. FOR FURTHER INFORMATION CONTACT: Long Chen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G472, Silver Spring, MD 20993-0002, 301-796-6389, [email protected]. 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 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112- 144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1) of the FD&C Act. Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. On January 13, 2015, EndyMed Medical Ltd., submitted a request for classification of the NewaTM device 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 request 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 request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on December 18, 2015, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 878.4420. [[Page 42244]] Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an electrosurgical device for over-the-counter aesthetic use will need to comply with the special controls named in this final order. The device is assigned the generic name electrosurgical device for over-the-counter aesthetic use, and it is identified as a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. Table 1--Electrosurgical Device for Over-the-Counter Aesthetic Use Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ Infection.............................. Cleaning Validation. Labeling. Adverse Tissue Reaction................ Biocompatibility. Skin Overheating/Burn.................. Clinical Performance Testing. Non-clinical Performance Testing. Software Verification, Validation and Hazards Analysis. Labeling. Electromagnetic Interference/Electrical Electromagnetic Compatibility Shock. Testing. Electrical Safety Testing. Labeling. Worsening Aesthetic Outcomes........... Clinical Performance Testing. Use Error.............................. Usability Study. Labeling. Failure to Identify Correct Population Label Comprehension and Self- and Condition. Selection Study. Labeling. ------------------------------------------------------------------------ FDA believes that the special controls, in addition to the general controls, address these risks to health and provide reasonable 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 electrosurgical device for over- the-counter aesthetic use they intend to market. II. Analysis of 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. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485. IV. Reference The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. 1. DEN150005: De Novo Request per 513(f)(2) from EndyMed Medical Ltd., dated January 13, 2015. 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 part 878 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 878.4420 to subpart E to read as follows: Sec. 878.4420 Electrosurgical device for over-the-counter aesthetic use. (a) Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters. (2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use. (3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the [[Page 42245]] directions for use, to treat the indicated aesthetic use. (4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Instructions for cleaning the device must be validated. (7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device. (8) Software verification, validation, and hazard analysis must be performed. (9) Labeling must include: (i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users. (ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known. (iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events. Dated: June 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-15381 Filed 6-28-16; 8:45 am] BILLING CODE 4164-01-P
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(d) Civil money penalties that are ACTION: Final order. receiving an order classifying the device
assessed under this subpart are subject into class III under section 513(f)(1) of
to annual adjustments to account for SUMMARY: The Food and Drug the FD&C Act, the person requests a
inflation as required by the Federal Civil Administration (FDA) is classifying the classification under section 513(f)(2).
Penalties Inflation Adjustment Act electrosurgical device for over-the- Under the second procedure, rather than
Improvements Act of 2015 (Pub. L. 114– counter aesthetic use into class II first submitting a premarket notification
74, sec. 701, 129 Stat. 584) (see also 12 (special controls). The special controls under section 510(k) of the FD&C Act
CFR 308.132(d)(17)). that will apply to the device are and then a request for classification
identified in this order and will be part under the first procedure, the person
* * * * *
of the codified language for the determines that there is no legally
PART 327—ASSESSMENTS electrosurgical device for over-the- marketed device upon which to base a
counter aesthetic use’s classification. determination of substantial
■ 4. The authority citation for part 327 The Agency is classifying the device equivalence and requests a classification
continues to read as follows: into class II (special controls) in order under section 513(f)(2) of the FD&C Act.
Authority: 12 U.S.C. 1441, 1813, 1815, to provide a reasonable assurance of If the person submits a request to
1817–19, 1821. safety and effectiveness of the device. classify the device under this second
DATES: This order is effective June 29, procedure, FDA may decline to
■ 5. Revise § 327.3(c) to read as follows:
2016. The classification was applicable undertake the classification request if
§ 327.3 Payment of assessments. on December 18, 2015. FDA identifies a legally marketed device
* * * * * FOR FURTHER INFORMATION CONTACT: that could provide a reasonable basis for
(c) Necessary action, sufficient Long Chen, Center for Devices and review of substantial equivalence with
funding by institution. Each insured Radiological Health, Food and Drug the device or if FDA determines that the
depository institution shall take all Administration, 10903 New Hampshire device submitted is not of ‘‘low-
actions necessary to allow the Ave., Bldg. 66, Rm. G472, Silver Spring, moderate risk’’ or that general controls
Corporation to debit assessments from MD 20993–0002, 301–796–6389, would be inadequate to control the risks
the insured depository institution’s Long.Chen@fda.hhs.gov. and special controls to mitigate the risks
designated deposit account. Each SUPPLEMENTARY INFORMATION: cannot be developed.
insured depository institution shall, In response to a request to classify a
prior to each payment date indicated in I. Background device under either procedure provided
paragraph (b)(2) of this section, ensure In accordance with section 513(f)(1) of by section 513(f)(2) of the FD&C Act,
that funds in an amount at least equal the Federal Food, Drug, and Cosmetic FDA will classify the device by written
to the amount on the quarterly certified Act (the FD&C Act) (21 U.S.C. order within 120 days. This
statement invoice are available in the 360c(f)(1)), devices that were not in classification will be the initial
designated account for direct debit by commercial distribution before May 28, classification of the device.
the Corporation. Failure to take any 1976 (the date of enactment of the On January 13, 2015, EndyMed
such action or to provide such funding Medical Device Amendments of 1976), Medical Ltd., submitted a request for
of the account shall be deemed to generally referred to as postamendments classification of the NewaTM device
constitute nonpayment of the devices, are classified automatically by under section 513(f)(2) of the FD&C Act.
assessment. Penalties for failure to statute into class III without any FDA The manufacturer recommended that
timely pay assessments are provided for rulemaking process. These devices the device be classified into class II (Ref.
at 12 CFR 308.132(d)(9). remain in class III and require 1).
* * * * * premarket approval, unless and until In accordance with section 513(f)(2) of
the device is classified or reclassified the FD&C Act, FDA reviewed the
Dated at Washington, DC, this 21st day of
into class I or II, or FDA issues an order request in order to classify the device
June, 2016.
finding the device to be substantially under the criteria for classification set
By order of the Board of Directors.
equivalent, in accordance with section forth in section 513(a)(1) of the FD&C
Federal Deposit Insurance Corporation. 513(i) of the FD&C Act, to a predicate Act. FDA classifies devices into class II
Robert E. Feldman, device that does not require premarket if general controls by themselves are
Executive Secretary. approval. The Agency determines insufficient to provide reasonable
[FR Doc. 2016–15027 Filed 6–28–16; 8:45 am] whether new devices are substantially assurance of safety and effectiveness,
BILLING CODE 6714–01–P equivalent to predicate devices by but there is sufficient information to
means of premarket notification establish special controls to provide
procedures in section 510(k) of the reasonable assurance of the safety and
DEPARTMENT OF HEALTH AND FD&C Act (21 U.S.C. 360(k)) and part effectiveness of the device for its
HUMAN SERVICES 807 (21 CFR part 807) of the regulations. intended use. After review of the
Section 513(f)(2) of the FD&C Act as information submitted in the request,
Food and Drug Administration amended by section 607 of the Food and FDA determined that the device can be
Drug Administration Safety and classified into class II with the
21 CFR Part 878 Innovation Act (Pub. L. 112–144), establishment of special controls. FDA
provides two procedures by which a believes these special controls, in
[Docket No. FDA–2016–N–1618] person may request FDA to classify a addition to general controls, will
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device under the criteria set forth in provide reasonable assurance of the
Medical Devices; General and Plastic
section 513(a)(1) of the FD&C Act. safety and effectiveness of the device.
Surgery Devices; Classification of the
Electrosurgical Device for Over-the- Under the first procedure, the person Therefore, on December 18, 2015,
Counter Aesthetic Use submits a premarket notification under FDA issued an order to the requestor
section 510(k) of the FD&C Act for a classifying the device into class II. FDA
AGENCY: Food and Drug Administration, device that has not previously been is codifying the classification of the
HHS. classified and, within 30 days of device by adding 21 CFR 878.4420.
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directions for use, to treat the indicated DC 20523; telephone: (202) 712–4080 dimension does . . . enter into the
aesthetic use. (this is not a toll-free number). analysis.’’ 1 The Second Circuit also
(4) Clinical performance evaluation SUPPLEMENTARY INFORMATION: suggested that the requirements of the
must demonstrate that the device Establishment Clause might be relaxed
performs as intended under anticipated I. Background in certain circumstances, noting that
conditions of use to achieve the On October 20, 2004, USAID ‘‘the fact that a particular grantee is the
intended aesthetic results. published its final rule (the ‘‘Current only channel for aid, or that a given
(5) The patient-contacting Rule’’) on participation by religious country has no secular education system
components of the device must be organizations in USAID programs (69 at all, may warrant overriding the usual
demonstrated to be biocompatible. FR 61716, codified at 22 CFR parts 202, Establishment Clause presumption.’’ Id.,
(6) Instructions for cleaning the 205, 211, and 226). The Current Rule at 842. Under these circumstances, the
device must be validated. implemented Executive Branch policy Second Circuit said, ‘‘[t]he court would
(7) Performance data must be that, within the framework of then scrutinize the manner in which the
provided to demonstrate the Constitutional guidelines, religious institution may use its grant in an
electromagnetic compatibility and organizations should be able to compete attempt to ascertain whether, in reality,
electrical safety, including the on an equal footing with other the grant would have the principal or
mechanical integrity, of the device. organizations for USAID funding. The primary effect of advancing religion.’’
(8) Software verification, validation, Current Rule revised USAID regulations Id. The Second Circuit also indicated
and hazard analysis must be performed. pertaining to grants, cooperative that the foreign policy ramifications of
(9) Labeling must include: agreements and contracts awarded for the case made it particularly
(i) Warnings, precautions, and the purpose of administering grant inappropriate to adopt a mechanical
contraindications to ensure the safe use programs to ensure their compliance approach to the Establishment Clause.
of the device for the over-the-counter with this policy and to clarify that The final rule will permit USAID to take
users. religious organizations are eligible to these considerations into account, in
(ii) A statement that the safety and participate in programs on the same consultation with DOJ.
effectiveness of the device’s use for uses basis as any other organization, with In addition, the Current Rule is more
other than the indicated aesthetic use respect to programs for which such restrictive than at least two legal
are not known. other organizations are eligible. opinions written by the U.S. Department
(iii) A summary of the clinical Among other things, the Current Rule of Justice’s Office of Legal Counsel. In
information used to establish provided that USAID funds could be a September 25, 2002 Memorandum
effectiveness for each indicated used for the acquisition, construction, or Opinion for the General Counsel of
aesthetic usage and observed adverse rehabilitation of structures only to the FEMA, Authority of FEMA to provide
events. extent that those structures were used Disaster Assistance to Seattle Hebrew
Dated: June 22, 2016. for conducting eligible activities under Academy, the Office of Legal Counsel
the specific USAID program. Where a concluded that FEMA could provide a
Leslie Kux,
structure also is used for inherently disaster assistance grant to the Seattle
Associate Commissioner for Policy. religious activities, the Current Rule Hebrew Academy, for repairs to the
[FR Doc. 2016–15381 Filed 6–28–16; 8:45 am] clarified that USAID funds could not Academy following the Nisqually
BILLING CODE 4164–01–P exceed the cost of those portions of the Earthquake on February 28, 2001. The
acquisition, construction, or Current Rule may not permit USAID to
rehabilitation that were attributable to provide assistance under similar
AGENCY FOR INTERNATIONAL eligible activities. The Current Rule circumstances to a religious school or
DEVELOPMENT went on to state that USAID funds could other religious structure in the aftermath
not be used for acquisition, of a natural disaster overseas. In an
22 CFR Part 205 construction, or rehabilitation of April 30, 2003 Memorandum Opinion
RIN 0412–AA69 sanctuaries, chapels, or any other room for the Solicitor of the Department of the
that a religious congregation that is a Interior, Authority of the Department of
Participation by Religious recipient or sub-recipient of USAID the Interior to Provide Historic
Organizations in USAID Programs assistance uses as its principal place of Preservation Grants to Historic Religious
worship. Since the implementation of Properties Such as the Old North
AGENCY: U.S. Agency for International the Current Rule, USAID has found that Church, the Office of Legal Counsel
Development (USAID). this provision has constricted its ability concluded that the Establishment
ACTION: Final rule. to pursue the national security and Clause did not bar the award of historic
foreign policy interests of the United preservation grants to the Old North
SUMMARY: This rule amends AID
States overseas. Church or other active houses of
regulations to address provisions which The Supreme Court has not addressed worship that qualify for such assistance.
are more restrictive than relevant whether the Establishment Clause The current rule does not permit the use
Federal case law and relevant legal applies extraterritorially. In Lamont v. of USAID funds for acquisition,
opinions issued by the United States Woods, 948 F.2d 825, 834 (2d Cir. 1991), construction, or rehabilitation of
Department of Justice with respect to the Second Circuit concluded that the structures to the extent that those
the applicability of the Establishment Establishment Clause applies to structures are used for inherently
Clause to the use of Federal funds. government grants to foreign religious religious activities, and further does not
mstockstill on DSK3G9T082PROD with RULES
DATES: This rule will be effective July institutions located abroad. In dicta in permit the acquisition, construction, or
29, 2016. Lamont, the court said that ‘‘domestic rehabilitation of sanctuaries, chapels, or
FOR FURTHER INFORMATION CONTACT: Establishment Clause jurisprudence has any other room that a religious
Mark Brinkmoeller, Director, Center for more than enough flexibility to congregation uses as its principal place
Faith-Based and Community Initiatives, accommodate any special circumstances of worship, and thus likely would not
USAID, Room 6.07–023, 1300 created by the foreign situs of the
Pennsylvania Avenue NW., Washington, expenditures, although the international 1 Id. at 841.
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Document Created: 2018-02-08 07:42:43
Document Modified: 2018-02-08 07:42:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective June 29, 2016. The classification was applicable on December 18, 2015. | |
| Contact | Long Chen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G472, Silver Spring, MD 20993-0002, 301-796-6389, [email protected] | |
| FR Citation | 81 FR 42243 |
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