83 FR 5033 - Medical Devices; Neurological Devices; Classification of the Percutaneous Nerve Stimulator for Substance Use Disorders
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 24 (February 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 24 (February 5, 2018)
| Page Range | 5033-5035 | |
| FR Document | 2018-02202 |
[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)] [Rules and Regulations] [Pages 5033-5035] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02202] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2018-N-0371] Medical Devices; Neurological Devices; Classification of the Percutaneous Nerve Stimulator for Substance Use Disorders AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the percutaneous nerve stimulator for substance use disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. DATES: This order is effective February 5, 2018. The classification was applicable on November 15, 2017. FOR FURTHER INFORMATION CONTACT: Eric Franca, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2684, Silver Spring, MD 20993-0002, 301-796-6285, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the percutaneous nerve stimulator for substance use disorders as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ``postamendments devices'' because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively). FDA may also classify a device through ``De Novo'' classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to [[Page 5034]] the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining ``substantial equivalence''). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification On March 17, 2017, Innovative Health Solutions, Inc., submitted a request for De Novo classification of the NSS-2 BRIDGE. 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. We classify 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 that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on November 15, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.5896. We have named the generic type of device percutaneous nerve stimulator for substance use disorders, and it is identified as a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders. 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--Percutaneous Nerve Stimulator for Substance Use Disorders Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Adverse tissue reaction...... Biocompatibility evaluation and Labeling. Electrical, mechanical, or Electromagnetic compatibility testing; thermal hazards leading to Electrical, mechanical, and thermal user discomfort or injury. safety testing; Non-clinical performance testing; Software verification, validation, and hazard analysis; and Labeling. Infection.................... Sterility testing, Shelf life testing, and Labeling. ------------------------------------------------------------------------ FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k). III. 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. IV. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. 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 the guidance document ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' have been approved under OMB control number 0910-0844; the collections of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; 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. List of Subjects in 21 CFR Part 882 Medical devices, Neurological 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, 360l, 371. 0 2. Add Sec. 882.5896 to subpart F to read as follows: Sec. 882.5896 Percutaneous nerve stimulator for substance use disorders. (a) Identification. A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders. (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) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed. (3) Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) Sterility testing of the percutaneous components of the device must be performed. (6) Shelf life testing must be performed to demonstrate continued [[Page 5035]] sterility, package integrity, and device functionality over the specified shelf life. (7) Labeling must include the following: (i) A detailed summary of the device technical parameters; (ii) A warning stating that the device is only for use on clean, intact skin; (iii) Instructions for use, including placement of the device on the patient; and (iv) A shelf life. Dated: January 31, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02202 Filed 2-2-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Rules and Regulations 5033
market. There is pent up demand for Dated: January 31, 2018. The automatic assignment of class III
additional Far West Native spearmint Bruce Summers, occurs by operation of law and without
oil that will not be available under the Acting Administrator, Agricultural Marketing any action by FDA, regardless of the
volume regulation provisions of the Service. level of risk posed by the new device.
Order until this final rule is effective. [FR Doc. 2018–02264 Filed 2–2–18; 8:45 am] Any device that was not in commercial
Handlers want to take advantage of the BILLING CODE 3410–02–P distribution before May 28, 1976, is
relaxation of the limitation on the automatically classified as, and remains
salable quantity of oil as soon as within, class III and requires premarket
possible, as delay will likely result in DEPARTMENT OF HEALTH AND approval unless and until FDA takes an
the loss of marketing opportunities, in HUMAN SERVICES action to classify or reclassify the device
both the short and long term. Native (see 21 U.S.C. 360c(f)(1)). We refer to
spearmint oil demand that cannot be Food and Drug Administration these devices as ‘‘postamendments
satisfied from spearmint oil from the Far devices’’ because they were not in
West production area may be fulfilled 21 CFR Part 882 commercial distribution prior to the
from other U.S. production areas or date of enactment of the Medical Device
[Docket No. FDA–2018–N–0371]
imported product. The loss of Amendments of 1976, which amended
immediate business resulting from a Medical Devices; Neurological the Federal Food, Drug, and Cosmetic
delayed implementation of this rule Devices; Classification of the Act (FD&C Act).
could result in customers entering into Percutaneous Nerve Stimulator for FDA may take a variety of actions in
long term contracts with other Native Substance Use Disorders appropriate circumstances to classify or
spearmint oil providers. There is reclassify a device into class I or II. We
therefore a risk that delayed AGENCY: Food and Drug Administration, may issue an order finding a new device
implementation of this rule would have HHS. to be substantially equivalent under
a negative impact on Far West ACTION: Final order. section 513(i) of the FD&C Act to a
spearmint oil handlers’ sales in future predicate device that does not require
SUMMARY: The Food and Drug premarket approval (see 21 U.S.C.
marketing years. Administration (FDA or we) is 360c(i)). We determine whether a new
List of Subjects in 7 CFR Part 985 classifying the percutaneous nerve device is substantially equivalent to a
stimulator for substance use disorders predicate by means of the procedures
Marketing agreements, Oils and fats,
into class II (special controls). The for premarket notification under section
Reporting and recordkeeping
special controls that apply to the device 510(k) of the FD&C Act and part 807 (21
requirements, Spearmint oil.
type are identified in this order and will U.S.C. 360(k) and 21 CFR part 807,
For the reasons set forth in the be part of the codified language for the
preamble, 7 CFR part 985 is amended as respectively).
percutaneous nerve stimulator for FDA may also classify a device
follows: substance use disorders’ classification. through ‘‘De Novo’’ classification, a
We are taking this action because we common name for the process
PART 985—MARKETING ORDER
have determined that classifying the authorized under section 513(f)(2) of the
REGULATING THE HANDLING OF
device into class II (special controls) FD&C Act. Section 207 of the Food and
SPEARMINT OIL PRODUCED IN THE
will provide a reasonable assurance of Drug Administration Modernization Act
FAR WEST
safety and effectiveness of the device. of 1997 established the first procedure
■ 1. The authority citation for 7 CFR We believe this action will also enhance for De Novo classification (Pub. L. 105–
part 985 continues to read as follows: patients’ access to beneficial innovative 115). Section 607 of the Food and Drug
devices, in part by reducing regulatory Administration Safety and Innovation
Authority: 7 U.S.C. 601–674. burdens. Act modified the De Novo application
[Subpart Redesignated as Subpart A] DATES: This order is effective February process by adding a second procedure
5, 2018. The classification was (Pub. L. 112–144). A device sponsor
■ 2. Redesignate ‘‘Subpart-Order applicable on November 15, 2017. may utilize either procedure for De
Regulating Handling’’ as ‘‘Subpart A- FOR FURTHER INFORMATION CONTACT: Eric Novo classification.
Order Regulating Handling’’. Franca, Center for Devices and Under the first procedure, the person
Radiological Health, Food and Drug submits a 510(k) for a device that has
[Subpart Redesignated as Subpart B Administration, 10903 New Hampshire not previously been classified. After
and Amended] Ave., Bldg. 66, Rm. 2684, Silver Spring, receiving an order from FDA classifying
MD 20993–0002, 301–796–6285, the device into class III under section
■ 3. Redesignate ‘‘Subpart- Eric.Franca@fda.hhs.gov. 513(f)(1) of the FD&C Act, the person
Administrative Rules and Regulations’’ then requests a classification under
SUPPLEMENTARY INFORMATION:
as subpart B and revise the heading to section 513(f)(2).
read as follows: I. Background Under the second procedure, rather
Upon request, FDA has classified the than first submitting a 510(k) and then
Subpart B—Administrative
percutaneous nerve stimulator for a request for classification, if the person
Requirements
substance use disorders as class II determines that there is no legally
■ 4. In § 985.236, revise paragraph (b) to (special controls), which we have marketed device upon which to base a
read as follows: determined will provide a reasonable determination of substantial
nshattuck on DSK9F9SC42PROD with RULES
assurance of safety and effectiveness. In equivalence, that person requests a
§ 985.236 Salable quantities and allotment addition, we believe this action will classification under section 513(f)(2) of
percentages—2017–2018 marketing year. enhance patients’ access to beneficial the FD&C Act.
* * * * * innovation, in part by reducing Under either procedure for De Novo
(b) Class 3 (Native) oil—a salable regulatory burdens by placing the classification, FDA shall classify the
quantity of 1,514,902 pounds and an device into a lower device class than the device by written order within 120 days.
allotment percentage of 62 percent. automatic class III assignment. The classification will be according to
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![Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Rules and Regulations 5035
sterility, package integrity, and device SUPPLEMENTARY INFORMATION: vessels during the rowing event on
functionality over the specified shelf navigable waters.
I. Table of Abbreviations
life.
IV. Discussion of the Rule
(7) Labeling must include the CFR Code of Federal Regulations
following: COTP Captain of the Port Sector Mobile This rule establishes a special local
(i) A detailed summary of the device DHS Department of Homeland Security regulation on February 24, 2018, which
technical parameters; FR Federal Register will be enforced between the 6 a.m. and
(ii) A warning stating that the device NPRM Notice of proposed rulemaking
PATCOM Patrol Commander
noon. The special local regulation takes
is only for use on clean, intact skin; §§ Section place on the Black Warrior River
(iii) Instructions for use, including U.S.C. United States Code between mile markers 339.0 and 341.5,
placement of the device on the patient; extending the entire width of the
and II. Background Information and navigable channel. The duration of the
(iv) A shelf life. Regulatory History regulation is intended to protect
Dated: January 31, 2018. The Coast Guard is issuing this participants, spectators, and other
Leslie Kux, temporary rule without prior notice and persons and vessels before, during, and
Associate Commissioner for Policy. opportunity to comment pursuant to after the rowing event. No vessel or
[FR Doc. 2018–02202 Filed 2–2–18; 8:45 am] authority under section 4(a) of the person will be permitted to enter into,
Administrative Procedure Act (APA) (5 transit through, or exist the regulated
BILLING CODE 4164–01–P
U.S.C. 553(b)). This provision area without obtaining permission from
authorizes an agency to issue a rule the COTP or a designated
without prior notice and opportunity to representative.
DEPARTMENT OF HOMELAND The Coast Guard will patrol the
SECURITY comment when the agency for good
cause finds that those procedures are regatta area under the direction of the
Coast Guard ‘‘impracticable, unnecessary, or contrary COTP, or a designated representative. A
to the public interest.’’ Under 5 U.S.C. designated representative may be a
33 CFR Part 100 553(b)(B), the Coast Guard finds that Coast Guard Patrol Commander
good cause exists for not publishing a (PATCOM). Patrol Commander
[Docket Number USCG–2018–0009] notice of proposed rulemaking (NPRM) (PATCOM) means a Coast Guard
RIN 1625–AA08 with respect to this rule because doing commissioned, warrant, or petty officer
so would be impracticable. The event who has been designated by the COTP
Special Local Regulation; Black sponsors have informed the U.S. Coast to monitor the rowing area, permit entry
Warrior River; Tuscaloosa, AL Guard that a marine event will occur on into the area, give legally enforceable
February 24, 2018. After gathering all orders to persons or vessels within the
AGENCY: Coast Guard, DHS. area, and take other actions authorized
necessary information, including safety
ACTION: Temporary final rule. needs related to this event, the Coast by the COTP. The PATCOM will be
Guard determined that this special local aboard either a Coast Guard or Coast
SUMMARY: The Coast Guard is
regulation is necessary for this event. It Guard Auxiliary vessel. The PATCOM
establishing a temporary special local
is impracticable to publish an NPRM may be contacted on Channel 16 (156.8
regulation on the Black Warrior River
because we must establish this special MHZ) by the call sign ‘‘Coast Guard
extending the entire width of the river
local regulation by February 24, 2018 Patrol Commander.’’
from mile marker 339.0 to mile marker
341.5 in Tuscaloosa, AL. The special and lack sufficient time to provide a All persons and vessels not registered
local regulation is needed to protect the reasonable comment period and then with the event sponsor as participants
persons participating in the NCAA consider those comments before issuing or official patrol vessels are considered
Collegiate Rowing Competition marine this rule. spectators. The ‘‘official patrol vessels’’
event. Entry into, transiting through, or Under 5 U.S.C. 553(d)(3), the Coast consist of any Coast Guard, state, or
exiting from this regulated area is Guard finds that good cause exists for local law enforcement and sponsor
prohibited unless specifically making this temporary rule effective less provided vessels assigned or approved
authorized by the Captain of the Port than 30 days after publication in the by the COTP to patrol the regulated
Sector Mobile, or a designated Federal Register. Delaying the effective area.
representative. date of this rule would be impracticable Spectator vessels desiring to enter,
and contrary to the public interest transit through or within, or exit the
DATES: This rule is effective from 6 a.m. because immediate action is necessary regulated area may request permission
until noon on February 24, 2018. to protect persons and property from the to do so from the COTP or a PATCOM.
ADDRESSES: To view documents dangers associated with the rowing When permitted to transit the area
mentioned in this preamble as being event. vessels must follow restrictions within
available in the docket, go to http:// the regulated area as directed by the
www.regulations.gov, type USCG–2018– III. Legal Authority and Need for Rule Coast Guard, and must operate at a
0009 in the ‘‘SEARCH’’ box and click The Coast Guard is issuing this rule minimum safe navigation speed in a
‘‘SEARCH.’’ Click on Open Docket under authority in 33 U.S.C. 1233. The manner which will not endanger
Folder on the line associated with this Captain of the Port Sector Mobile participants in the regulated area or any
rule. (COTP) has determined that potential other vessels.
nshattuck on DSK9F9SC42PROD with RULES
FOR FURTHER INFORMATION CONTACT: If hazards associated with the rowing No spectator vessel shall anchor,
you have questions on this rule, call or event on February 24, 2018 will be a block, loiter, or impede the through
email Lieutenant Kyle D. Berry, Sector safety concern for anyone within the transit of participants or official patrol
Mobile, Waterways Management area of the Black Warrior River between vessels in the regulated area during the
Division, U.S. Coast Guard; telephone mile markers 339.0 and 341.5. This rule effective dates and times, unless cleared
251–441–5940, email Kyle.D.Berry@ is needed to protect participants, for entry by or through an official patrol
uscg.mil. spectators, and other persons and vessel.
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Document Created: 2018-02-03 01:24:40
Document Modified: 2018-02-03 01:24:40
| 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 February 5, 2018. The classification was applicable on November 15, 2017. | |
| Contact | Eric Franca, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2684, Silver Spring, MD 20993-0002, 301-796-6285, [email protected] | |
| FR Citation | 83 FR 5033 | |
| CFR Associated | Medical Devices and Neurological Devices |
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