81 FR 44771 - Medical Devices; Neurological Devices; Classification of the Thermal System for Insomnia
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 132 (July 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 132 (July 11, 2016)
| Page Range | 44771-44773 | |
| FR Document | 2016-16351 |
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)] [Rules and Regulations] [Pages 44771-44773] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16351] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2016-N-1653] Medical Devices; Neurological Devices; Classification of the Thermal System for Insomnia AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the thermal system for insomnia 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 thermal system for insomnia'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 July 11, 2016. The classification was applicable on May 13, 2016. FOR FURTHER INFORMATION CONTACT: Leigh Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 301-796-5613, leigh.anderson@fda.hhs.gov. 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). 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. [[Page 44772]] In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On October 17, 2014, Cer[ecirc]ve Inc. submitted a request for classification of the Cer[ecirc]ve Sleep System 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 May 13, 2016, 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 882.5700. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a thermal system for insomnia will need to comply with the special controls named in this final order. The device is assigned the generic name thermal system for insomnia, and it is identified as a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface. FDA has identified the following risks to health associated specifically with this type of device, as well as the mitigation measures required to mitigate these risks in table 1: Table 1--Thermal System for Insomnia Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation method ------------------------------------------------------------------------ Adverse skin reaction.................. Biocompatibility Assessment. Labeling. Electromagnetic Interference with Other Electromagnetic Compatibility Devices. Testing. Labeling. Electrical Safety (e.g., shock)........ Electrical Safety Testing. Labeling. Thermal Injury......................... Non-clinical Performance Testing. Software Verification, Validation, and Hazard Analysis. Labeling. ------------------------------------------------------------------------ FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. Thermal systems for insomnia devices are not safe to use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109 Prescription devices). 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 thermal system for insomnia 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. DEN140032 De novo Request per 513(f)(2) from Cer[ecirc]ve, Inc., dated October 17, 2014. List of Subjects in 21 CFR Part 882 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 882 is amended as follows: PART 882--NEUROLOGICAL DEVICES 0 1. The authority citation for part 882 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 882.5700 to subpart F to read as follows: Sec. 882.5700 Thermal system for insomnia. (a) Identification. A thermal system for insomnia is a prescription device for use in patients with insomnia that is [[Page 44773]] used to apply a specified temperature to the skin surface. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate electromagnetic compatibility and electrical safety. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Thermal performance of the device, including maintenance of the target temperature, must be evaluated under simulated use conditions. (ii) Mechanical testing to demonstrate the device can withstand forces under anticipated use conditions. (iii) Mechanical testing to demonstrate the device is resistant to leakage under anticipated use conditions. (4) Software verification, validation, and hazard analysis must be performed. (5) Patient labeling must be provided to convey information regarding safe use of the device, including instructions for assembly. Dated: July 5, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-16351 Filed 7-8-16; 8:45 am] BILLING CODE 4164-01-P
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PART 730—[AMENDED] PART 746—[AMENDED] I. Background
■ 4. The authority citation for part 746 In accordance with section 513(f)(1) of
■ 1. The authority citation for part 730
is revised to read as follows: the Federal Food, Drug, and Cosmetic
is revised to read as follows:
Act (the FD&C Act) (21 U.S.C.
Authority: 50 U.S.C. 4601 et seq.; 50 Authority: 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 287c; Sec. 360c(f)(1)), devices that were not in
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. commercial distribution before May 28,
1503, Pub. L. 108–11, 117 Stat. 559; 22 U.S.C.
7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 note; 1976 (the date of enactment of the
6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42
E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., Medical Device Amendments of 1976),
U.S.C. 2139a; 15 U.S.C. 1824a; 50 U.S.C.
p. 614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 generally referred to as postamendments
4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
Comp., p. 899; E.O. 13222, 66 FR 44025, 3 devices, are classified automatically by
E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR
p. 114; E.O. 12002, 42 FR 35623, 3 CFR, 1977 statute into class III without any FDA
26751, 3 CFR, 2004 Comp., p 168;
Comp., p. 133; E.O. 12058, 43 FR 20947, 3 rulemaking process. These devices
Presidential Determination 2003–23, 68 FR
CFR, 1978 Comp., p. 179; E.O. 12214, 45 FR 26459, 3 CFR, 2004 Comp., p. 320; remain in class III and require
29783, 3 CFR, 1980 Comp., p. 256; E.O. Presidential Determination 2007–7, 72 FR premarket approval, unless and until
12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 1899, 3 CFR, 2006 Comp., p. 325; Notice of the device is classified or reclassified
608; E.O. 12854, 58 FR 36587, 3 CFR, 1993 August 7, 2015, 80 FR 48233 (August 11, into class I or II, or FDA issues an order
Comp., p. 179; E.O. 12918, 59 FR 28205, 3 2015); Notice of May 3, 2016, 81 FR 27293 finding the device to be substantially
CFR, 1994 Comp., p. 899; E.O. 12938, 59 FR (May 5, 2016). equivalent, in accordance with section
59099, 3 CFR, 1994 Comp., p. 950; E.O. 513(i) of the FD&C Act, to a predicate
Dated: July 6, 2016.
12947, 60 FR 5079, 3 CFR, 1995 Comp., p.
Kevin J. Wolf, device that does not require premarket
356; E.O. 12981, 60 FR 62981, 3 CFR, 1995
Comp., p. 419; E.O. 13020, 61 FR 54079, 3 Assistant Secretary for Export approval. The Agency determines
CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR Administration. whether new devices are substantially
58767, 3 CFR, 1996 Comp., p. 228; E.O. [FR Doc. 2016–16365 Filed 7–8–16; 8:45 am] equivalent to predicate devices by
13099, 63 FR 45167, 3 CFR, 1998 Comp., p. BILLING CODE 3510–33–P
means of premarket notification
208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 procedures in section 510(k) of the
Comp., p. 783; E.O. 13224, 66 FR 49079, 3 FD&C Act (21 U.S.C. 360(k)) and part
CFR, 2001 Comp., p. 786; E.O. 13338, 69 FR 807 (21 CFR part 807) of the regulations.
26751, 3 CFR, 2004 Comp., p 168; E.O. DEPARTMENT OF HEALTH AND Section 513(f)(2) of the FD&C Act, as
13637, 78 FR 16129, 3 CFR, 2014 Comp., p.
HUMAN SERVICES amended by section 607 of the Food and
223; Notice of August 7, 2015, 80 FR 48233
(August 11, 2015); Notice of September 18,
Drug Administration Safety and
Food and Drug Administration Innovation Act (Pub. L. 112–144),
2015, 80 FR 57281 (September 22, 2015);
Notice of November 12, 2015, 80 FR 70667 provides two procedures by which a
(November 13, 2015); Notice of January 20, 21 CFR Part 882 person may request FDA to classify a
2016, 81 FR 3937 (January 22, 2016); Notice device under the criteria set forth in
of May 3, 2016, 81 FR 27293 (May 5, 2016). [Docket No. FDA–2016–N–1653] section 513(a)(1). Under the first
procedure, the person submits a
PART 736—[AMENDED] Medical Devices; Neurological premarket notification under section
Devices; Classification of the Thermal 510(k) of the FD&C Act for a device that
■ 2. The authority citation for part 736 System for Insomnia has not previously been classified and,
is revised to read as follows: within 30 days of receiving an order
AGENCY: Food and Drug Administration,
Authority: 50 U.S.C. 4601 et seq.; 50 classifying the device into class III
HHS.
U.S.C. 1701 et seq.; 22 U.S.C. 2151 note; E.O. under section 513(f)(1) of the FD&C Act,
ACTION: Final order. the person requests a classification
12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 SUMMARY: The Food and Drug under section 513(f)(2). Under the
Comp., p. 219; E.O. 13026, 61 FR 58767, 3 Administration (FDA) is classifying the second procedure, rather than first
CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR
thermal system for insomnia into class submitting a premarket notification
44025, 3 CFR, 2001 Comp., p. 783; E.O. under section 510(k) of the FD&C Act
13338, 69 FR 26751, 3 CFR, 2004 Comp., p.
II (special controls). The special controls
that will apply to the device are and then a request for classification
168; Notice of August 7, 2015, 80 FR 48233 under the first procedure, the person
(August 11, 2015); Notice of November 12, identified in this order and will be part
of the codified language for the thermal determines that there is no legally
2015, 80 FR 70667 (November 13, 2015); marketed device upon which to base a
Notice of May 3, 2016, 81 FR 27293 (May 5, system for insomnia’s classification. The
Agency is classifying the device into determination of substantial
2016).
class II (special controls) in order to equivalence and requests a classification
PART 738—[AMENDED] provide a reasonable assurance of safety under section 513(f)(2) of the FD&C Act.
and effectiveness of the device. If the person submits a request to
■ 3. The authority citation for part 738 classify the device under this second
DATES: This order is effective July 11,
is revised to read as follows: procedure, FDA may decline to
2016. The classification was applicable undertake the classification request if
Authority: 50 U.S.C. 4601 et seq.; 50 on May 13, 2016. FDA identifies a legally marketed device
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. FOR FURTHER INFORMATION CONTACT: that could provide a reasonable basis for
7430(e); 22 U.S.C. 287c; 22 U.S.C. 3201 et Leigh Anderson, Center for Devices and review of substantial equivalence with
ehiers on DSK5VPTVN1PROD with RULES
seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 43 Radiological Health, Food and Drug
U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. 4305;
the device or if FDA determines that the
Administration, 10903 New Hampshire device submitted is not of ‘‘low-
22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
Ave., Bldg. 66, Rm. 2656, Silver Spring, moderate risk’’ or that general controls
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 MD 20993–0002, 301–796–5613, would be inadequate to control the risks
Comp., p. 783; Notice of August 7, 2015, 80 leigh.anderson@fda.hhs.gov. and special controls to mitigate the risks
FR 48233 (August 11, 2015). SUPPLEMENTARY INFORMATION: cannot be developed.
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used to apply a specified temperature to Internal Revenue Code (the Code), or otherwise give rise to prohibited
the skin surface. both, by reason of providing investment transactions as a result of their advice to
(b) Classification. Class II (special advice, to receive compensation that plan participants and beneficiaries, IRA
controls). The special controls for this may otherwise be prohibited. The owners and certain plan fiduciaries
device are: corrections in this document fix (including small plan sponsors). The
(1) The patient-contacting typographical errors, make minor exemption is subject to protective
components of the device must be clarifications to provisions that might conditions to safeguard the interests of
demonstrated to be biocompatible. otherwise be confusing, and confirm the plans, participants and beneficiaries
(2) Performance testing must insurers’ broad eligibility to rely on the and IRA owners.
demonstrate electromagnetic exemption, consistent with the The Best Interest Contract Exemption
compatibility and electrical safety. exemption’s clearly intended scope and is broadly available for Advisers and
(3) Non-clinical performance testing the analysis and data relied upon in the Financial Institutions that make
must demonstrate that the device Department’s final regulatory impact investment recommendations to retail
performs as intended under anticipated analysis (RIA). ‘‘Retirement Investors,’’ including plan
conditions of use. The following DATES: Issuance date: These technical participants and beneficiaries, IRA
performance characteristics must be corrections are issued July 11, 2016, owners, and non-institutional
evaluated: without further action or notice. fiduciaries (referred to in the exemption
(i) Thermal performance of the device, Applicability date: The Best Interest as ‘‘Retail Fiduciaries’’). As a condition
including maintenance of the target Contract Exemption, as corrected of receiving compensation that would
temperature, must be evaluated under herein, is applicable to transactions otherwise be prohibited under ERISA
simulated use conditions. occurring on or after April 10, 2017. and the Code, the exemption requires
(ii) Mechanical testing to demonstrate Financial Institutions to acknowledge
FOR FURTHER INFORMATION CONTACT:
the device can withstand forces under their fiduciary status and the fiduciary
Brian Shiker or Susan Wilker, Office of status of their Advisers in writing. The
anticipated use conditions.
(iii) Mechanical testing to Exemption Determinations, Employee Financial Institution and Advisers must
demonstrate the device is resistant to Benefits Security Administration, U.S. adhere to enforceable standards of
leakage under anticipated use Department of Labor, (202) 693–8824 fiduciary conduct and fair dealing with
conditions. (this is not a toll-free number). respect to their advice. In the case of
(4) Software verification, validation, SUPPLEMENTARY INFORMATION: IRAs and non-ERISA plans, the
and hazard analysis must be performed. Background exemption requires that the standards
(5) Patient labeling must be provided be set forth in an enforceable contract
to convey information regarding safe use The Best Interest Contract Exemption with the Retirement Investor; the
of the device, including instructions for was granted pursuant to ERISA section exemption permits reliance on a
assembly. 408(a) and Code section 4975(c)(2), and negative consent process for existing
in accordance with the procedures set contract holders. Under the exemption’s
Dated: July 5, 2016. forth in 29 CFR part 2570, subpart B (76
Leslie Kux,
terms, Financial Institutions are not
FR 66637 (October 27, 2011)). It was required to enter into a contract with
Associate Commissioner for Policy. adopted by the Department in ERISA plan investors, but they must
[FR Doc. 2016–16351 Filed 7–8–16; 8:45 am] connection with the publication of a adhere to these same standards of
BILLING CODE 4164–01–P final regulation defining who is a fiduciary conduct, which the investors
fiduciary of an employee benefit plan can effectively enforce pursuant to
under ERISA as a result of giving ERISA sections 502(a)(2) and (3).
DEPARTMENT OF LABOR investment advice to a plan or its Likewise, ‘‘Level Fee’’ Fiduciaries that,
participants or beneficiaries with their Affiliates, receive only a
Employee Benefits Security (Regulation).1 The Regulation also Level Fee in connection with advisory
Administration applies to the definition of a ‘‘fiduciary’’ or investment management services, do
of a plan (including an IRA) under the not have to enter into a contract with
29 CFR Part 2550 Code. Retirement Investors, but they must
[Application No. D–11712; Prohibited
The exemption provides relief from provide a written statement of fiduciary
Transaction Exemption 2016–01] provisions of ERISA and the Code that status, adhere to standards of fiduciary
generally prohibit fiduciaries with conduct, and prepare a written
[ZRIN 1210–ZA25] respect to employee benefit plans and documentation of the reasons for the
individual retirement accounts (IRAs) recommendation.
Best Interest Contract Exemption;
from engaging in self-dealing and
Correction Explanation of Corrections
receiving compensation from third
AGENCY: Employee Benefits Security parties in connection with transactions This document makes technical
Administration (EBSA), U.S. involving the plans and IRAs. The corrections to the Best Interest Contract
Department of Labor. exemption allows entities such as Exemption as described below. In
ACTION: Technical corrections. registered investment advisers, broker- addition, the document adds an
dealers, banks and insurance companies identifier, Prohibited Transaction
SUMMARY: This document makes (referred to in the exemption as Exemption 2016–01, to the heading of
technical corrections to the Department Financial Institutions), and their the Best Interest Contract Exemption.
of Labor’s Best Interest Contract employees, agents and representatives For convenience, the text of the
ehiers on DSK5VPTVN1PROD with RULES
Exemption, which was published in the (referred to as Advisers), that are ERISA corrected exemption is reprinted in its
Federal Register on April 8, 2016. The or Code fiduciaries by reason of the entirety at the conclusion of this
Best Interest Contract Exemption allows provision of investment advice, to document. The preamble to the
certain persons that are fiduciaries receive compensation that may originally granted exemption provides a
under the Employee Retirement Income general overview of the exemption, at 81
Security Act of 1974 (ERISA) or the 1 81 FR 20945 (April 8, 2016). FR 21002.
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Document Created: 2016-07-09 00:21:31
Document Modified: 2016-07-09 00:21:31
| 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 July 11, 2016. The classification was applicable on May 13, 2016. | |
| Contact | Leigh Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 301-796-5613, [email protected] | |
| FR Citation | 81 FR 44771 |
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