Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device, 67154-67155 [2016-23633]

Download as PDF 67154 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations In addition, the petition proposed that the animal food additive regulations for formic acid and ammonium formate be amended to limit formic acid and formate salts from all added sources to 1.2 percent of complete feeds. This element of the petition was not described in the July 2014 notice of petition. Elsewhere in this issue of the Federal Register, FDA is providing notice of BASF Corp.’s proposal that FDA amend the food additive regulations for formic acid and ammonium formate to limit formic acid and formate salts from all added sources to 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. II. Conclusion FDA concludes that the data establish the safety and utility of feed grade sodium formate for use as a feed acidifying agent in complete swine feeds and that the food additive regulations should be amended as set forth in this document. III. Public Disclosure In accordance with § 571.1(h) (21 CFR 571.1(h)), the petition and documents we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 571.1(h), we will delete from the documents any materials that are not available for public disclosure. asabaliauskas on DSK3SPTVN1PROD with RULES IV. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.32(r) 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. V. Objections and Hearing Requests Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES) either electronic or written objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provision of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. List of Subjects in 21 CFR Part 573 Animal feeds, Food additives. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is amended as follows: PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS 1. The authority citation for part 573 continues to read as follows: ■ Authority: 21 U.S.C. 321, 342, 348. ■ 2. Add § 573.696 to read as follows: § 573.696 Feed grade sodium formate. The food additive, feed grade sodium formate, may be safely used in the manufacture of complete swine feeds in accordance with the following prescribed conditions: (a) The additive is manufactured by the reaction of 99 percent formic acid and 50 percent sodium hydroxide in water to produce a solution made up of at least 20.5 percent sodium salt of formic acid and not more than 61 percent formic acid. (b) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine feeds at levels not to exceed 1.2 percent of the complete feed. (c) To assure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. (d) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall contain: (1) The name of the additive. (2) Adequate directions for use, including a statement that feed grade sodium formate must be uniformly applied and thoroughly mixed into PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 complete feeds and that the complete feeds so treated shall be labeled as containing feed grade sodium formate. (3) Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination. (e) To assure safe use of the additive, in addition to the other information required by the act and paragraph (d) of this section, the label and labeling shall contain: (1) Appropriate warnings and safety precautions concerning feed grade sodium formate. (2) Statements identifying feed grade sodium formate as a corrosive and possible severe irritant. (3) Information about emergency aid in case of accidental exposure as follows: (i) Statements reflecting requirements of applicable sections of the Superfund Amendments and Reauthorization Act (SARA), and the Occupational Safety and Health Administration (OSHA) human safety guidance regulations. (ii) Contact address and telephone number for reporting adverse reactions or to request a copy of the Material Safety Data Sheet (MSDS). Dated: September 26, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016–23671 Filed 9–29–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA 2016–N–2677] Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective September 30, 2016. The classification was applicable on July 15, 2016. SUMMARY: E:\FR\FM\30SER1.SGM 30SER1 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations FOR FURTHER INFORMATION CONTACT: Kristen Bowsher, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2646, Silver Spring, MD 20993–0002, 301–796–6448, kristen.bowsher@fda.hhs.gov. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK3SPTVN1PROD with RULES 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), 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 (21 U.S.C. 360c(f)(2)), 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), 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) 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 VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 review of substantial equivalence with the device or if FDA determines that the device submitted is not of ‘‘lowmoderate 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On January 12, 2015, EPIC Research & Diagnostics, Inc. submitted a request for classification of the EPIC ClearViewTM System under section 513(f)(2) of the FD&C Act. 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). FDA classifies devices into class I if general controls by themselves are sufficient to provide reasonable assurance of safety and effectiveness of the device for its intended use. After review of the information submitted in the de novo request, FDA determined that the device can be classified into class I. FDA believes general controls will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on July 15, 2016, FDA issued an order to the requestor classifying the device into class I. FDA is codifying the classification of the device by adding 21 CFR 882.1561. The device is assigned the generic name evoked photon image capture device, and it is identified as a prescription, electrically-powered device intended for use as a noninvasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes. FDA has identified the following risks to health associated specifically with this type of device: Adverse tissue reaction, electromagnetic incompatibility, and electromagnetic malfunction (e.g., shock). Evoked photon image capture devices are not safe for 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). PO 00000 Frm 00065 Fmt 4700 Sfmt 9990 67155 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 refers 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. 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 1. The authority citation for part 882 continues to read as follows: ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Add § 882.1561 to subpart B to read as follows: ■ § 882.1561 device. Evoked photon image capture (a) Identification. An evoked photon image capture device is a prescription, electrically powered device intended for use as a noninvasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 882.9. Dated: September 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–23633 Filed 9–29–16; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\30SER1.SGM 30SER1

Agencies

[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67154-67155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23633]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA 2016-N-2677]


Medical Devices; Neurological Devices; Classification of the 
Evoked Photon Image Capture Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
Evoked Photon Image Capture Device into class I (general controls). The 
Agency is classifying the device into class I (general controls) in 
order to provide a reasonable assurance of safety and effectiveness of 
the device.

DATES: This order is effective September 30, 2016. The classification 
was applicable on July 15, 2016.

[[Page 67155]]


FOR FURTHER INFORMATION CONTACT: Kristen Bowsher, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2646, Silver Spring, MD 20993-0002, 301-
796-6448, kristen.bowsher@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), 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 (21 U.S.C. 360c(f)(2)), 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), 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) 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 shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device. On 
January 12, 2015, EPIC Research & Diagnostics, Inc. submitted a request 
for classification of the EPIC ClearView\TM\ System under section 
513(f)(2) of the FD&C Act.
    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). FDA classifies devices 
into class I if general controls by themselves are sufficient to 
provide reasonable assurance of safety and effectiveness of the device 
for its intended use. After review of the information submitted in the 
de novo request, FDA determined that the device can be classified into 
class I. FDA believes general controls will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on July 15, 2016, FDA issued an order to the requestor 
classifying the device into class I. FDA is codifying the 
classification of the device by adding 21 CFR 882.1561.
    The device is assigned the generic name evoked photon image capture 
device, and it is identified as a prescription, electrically-powered 
device intended for use as a non-invasive measurement tool that applies 
electricity to detect electrophysiological signals emanating from the 
skin, which are reported numerically and as images without clinical 
interpretation. The device is not intended for diagnostic purposes.
    FDA has identified the following risks to health associated 
specifically with this type of device: Adverse tissue reaction, 
electromagnetic incompatibility, and electromagnetic malfunction (e.g., 
shock).
    Evoked photon image capture devices are not safe for 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).

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 refers 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.

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, 371.


0
2. Add Sec.  882.1561 to subpart B to read as follows:


Sec.  882.1561  Evoked photon image capture device.

    (a) Identification. An evoked photon image capture device is a 
prescription, electrically powered device intended for use as a 
noninvasive measurement tool that applies electricity to detect 
electrophysiological signals emanating from the skin, which are 
reported numerically and as images without clinical interpretation. The 
device is not intended for diagnostic purposes.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec.  882.9.

    Dated: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23633 Filed 9-29-16; 8:45 am]
BILLING CODE 4164-01-P