81 FR 67154 - Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 190 (September 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 190 (September 30, 2016)
| Page Range | 67154-67155 | |
| FR Document | 2016-23633 |
[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)] [Rules and Regulations] [Pages 67154-67155] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23633] ----------------------------------------------------------------------- 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, [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), 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
![67154 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations
In addition, the petition proposed that include a detailed description and complete feeds and that the complete
the animal food additive regulations for analysis of the specific factual feeds so treated shall be labeled as
formic acid and ammonium formate be information intended to be presented in containing feed grade sodium formate.
amended to limit formic acid and support of the objection in the event (3) Cautions for use including this
formate salts from all added sources to that a hearing is held. Failure to include statement: Caution: Follow label
1.2 percent of complete feeds. This such a description and analysis for any directions. Formic acid and formate
element of the petition was not particular objection shall constitute a salts from all added sources cannot
described in the July 2014 notice of waiver of the right to a hearing on the exceed 1.2 percent of complete feed
petition. objection. when multiple sources of formic acid
Elsewhere in this issue of the Federal Any objections received in response and its salts are used in combination.
Register, FDA is providing notice of to the regulation may be seen in the (e) To assure safe use of the additive,
BASF Corp.’s proposal that FDA amend Division of Dockets Management in addition to the other information
the food additive regulations for formic between 9 a.m. and 4 p.m., Monday required by the act and paragraph (d) of
acid and ammonium formate to limit through Friday, and will be posted to this section, the label and labeling shall
formic acid and formate salts from all the docket at http:// contain:
added sources to 1.2 percent of www.regulations.gov. (1) Appropriate warnings and safety
complete feed when multiple sources of precautions concerning feed grade
List of Subjects in 21 CFR Part 573 sodium formate.
formic acid and its salts are used in
combination. Animal feeds, Food additives. (2) Statements identifying feed grade
Therefore, under the Federal Food, sodium formate as a corrosive and
II. Conclusion possible severe irritant.
Drug, and Cosmetic Act and under
FDA concludes that the data establish authority delegated to the Commissioner (3) Information about emergency aid
the safety and utility of feed grade of Food and Drugs and redelegated to in case of accidental exposure as
sodium formate for use as a feed the Center for Veterinary Medicine, 21 follows:
acidifying agent in complete swine CFR part 573 is amended as follows: (i) Statements reflecting requirements
feeds and that the food additive of applicable sections of the Superfund
regulations should be amended as set PART 573—FOOD ADDITIVES Amendments and Reauthorization Act
forth in this document. PERMITTED IN FEED AND DRINKING (SARA), and the Occupational Safety
WATER OF ANIMALS and Health Administration (OSHA)
III. Public Disclosure human safety guidance regulations.
In accordance with § 571.1(h) (21 CFR ■ 1. The authority citation for part 573 (ii) Contact address and telephone
571.1(h)), the petition and documents continues to read as follows: number for reporting adverse reactions
we considered and relied upon in Authority: 21 U.S.C. 321, 342, 348. or to request a copy of the Material
reaching our decision to approve the ■ 2. Add § 573.696 to read as follows: Safety Data Sheet (MSDS).
petition will be made available for Dated: September 26, 2016.
public disclosure (see FOR FURTHER § 573.696 Feed grade sodium formate. Tracey H. Forfa,
INFORMATION CONTACT). As provided in The food additive, feed grade sodium Deputy Director, Center for Veterinary
§ 571.1(h), we will delete from the formate, may be safely used in the Medicine.
documents any materials that are not manufacture of complete swine feeds in [FR Doc. 2016–23671 Filed 9–29–16; 8:45 am]
available for public disclosure. accordance with the following BILLING CODE 4164–01–P
prescribed conditions:
IV. Analysis of Environmental Impact (a) The additive is manufactured by
The Agency has determined under 21 the reaction of 99 percent formic acid DEPARTMENT OF HEALTH AND
CFR 25.32(r) that this action is of a type and 50 percent sodium hydroxide in HUMAN SERVICES
that does not individually or water to produce a solution made up of
cumulatively have a significant effect on at least 20.5 percent sodium salt of Food and Drug Administration
the human environment. Therefore, formic acid and not more than 61
neither an environmental assessment, percent formic acid. 21 CFR Part 882
nor an environmental impact statement (b) The additive is used or intended
is required. [Docket No. FDA 2016–N–2677]
for use as a feed acidifying agent, to
V. Objections and Hearing Requests lower the pH, in complete swine feeds Medical Devices; Neurological
at levels not to exceed 1.2 percent of the Devices; Classification of the Evoked
Any person who will be adversely complete feed.
affected by this regulation may file with Photon Image Capture Device
(c) To assure safe use of the additive,
the Division of Dockets Management formic acid and formate salts from all AGENCY: Food and Drug Administration,
(see ADDRESSES) either electronic or added sources cannot exceed 1.2 HHS.
written objections. Each objection shall percent of complete feed when multiple ACTION: Final order.
be separately numbered, and each sources of formic acid and its salts are
numbered objection shall specify with used in combination. SUMMARY: The Food and Drug
particularity the provision of the (d) To assure safe use of the additive, Administration (FDA) is classifying the
regulation to which objection is made in addition to the other information Evoked Photon Image Capture Device
asabaliauskas on DSK3SPTVN1PROD with RULES
and the grounds for the objection. Each required by the Federal Food, Drug, and into class I (general controls). The
numbered objection on which a hearing Cosmetic Act, the label and labeling Agency is classifying the device into
is requested shall specifically so state. shall contain: class I (general controls) in order to
Failure to request a hearing for any (1) The name of the additive. provide a reasonable assurance of safety
particular objection shall constitute a (2) Adequate directions for use, and effectiveness of the device.
waiver of the right to a hearing on that including a statement that feed grade DATES: This order is effective September
objection. Each numbered objection for sodium formate must be uniformly 30, 2016. The classification was
which a hearing is requested shall applied and thoroughly mixed into applicable on July 15, 2016.
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![Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations 67155
FOR FURTHER INFORMATION CONTACT: review of substantial equivalence with II. Analysis of Environmental Impact
Kristen Bowsher, Center for Devices and the device or if FDA determines that the The Agency has determined under 21
Radiological Health, Food and Drug device submitted is not of ‘‘low- CFR 25.34(b) that this action is of a type
Administration, 10903 New Hampshire moderate risk’’ or that general controls that does not individually or
Ave., Bldg. 66, Rm. 2646, Silver Spring, would be inadequate to control the risks cumulatively have a significant effect on
MD 20993–0002, 301–796–6448, and special controls to mitigate the risks the human environment. Therefore,
kristen.bowsher@fda.hhs.gov. cannot be developed. neither an environmental assessment
SUPPLEMENTARY INFORMATION: In response to a request to classify a nor an environmental impact statement
I. Background device under either procedure provided is required.
by section 513(f)(2) of the FD&C Act,
In accordance with section 513(f)(1) of III. Paperwork Reduction Act of 1995
FDA shall classify the device by written
the Federal Food, Drug, and Cosmetic order within 120 days. This This final order refers to previously
Act (the FD&C Act) (21 U.S.C. classification will be the initial approved collections of information
360c(f)(1)), devices that were not in classification of the device. On January found in other FDA regulations. These
commercial distribution before May 28, 12, 2015, EPIC Research & Diagnostics, collections of information are subject to
1976 (the date of enactment of the Inc. submitted a request for review by the Office of Management and
Medical Device Amendments of 1976), classification of the EPIC ClearViewTM Budget (OMB) under the Paperwork
generally referred to as postamendments System under section 513(f)(2) of the Reduction Act of 1995 (44 U.S.C. 3501–
devices, are classified automatically by FD&C Act. 3520). The collections of information in
statute into class III without any FDA part 807, subpart E, regarding premarket
rulemaking process. These devices In accordance with section 513(f)(2) of
notification submissions have been
remain in class III and require the FD&C Act, FDA reviewed the
approved under OMB control number
premarket approval, unless and until request in order to classify the device
0910–0120, and the collections of
the device is classified or reclassified under the criteria for classification set
information in 21 CFR part 801,
into class I or II, or FDA issues an order forth in section 513(a)(1). FDA classifies
regarding labeling have been approved
finding the device to be substantially devices into class I if general controls by
under OMB control number 0910–0485.
equivalent, in accordance with section themselves are sufficient to provide
513(i), to a predicate device that does reasonable assurance of safety and List of Subjects in 21 CFR Part 882
not require premarket approval. The effectiveness of the device for its Medical devices, Neurological
Agency determines whether new intended use. After review of the devices.
devices are substantially equivalent to information submitted in the de novo
request, FDA determined that the device Therefore, under the Federal Food,
predicate devices by means of Drug, and Cosmetic Act and under
premarket notification procedures in can be classified into class I. FDA
believes general controls will provide authority delegated to the Commissioner
section 510(k) of the FD&C Act (21 of Food and Drugs, 21 CFR part 882 is
U.S.C. 360(k)) and part 807 (21 CFR part reasonable assurance of the safety and
effectiveness of the device. amended as follows:
807) of the regulations.
Section 513(f)(2) of the FD&C Act (21 Therefore, on July 15, 2016, FDA PART 882—NEUROLOGICAL DEVICES
U.S.C. 360c(f)(2)), as amended by issued an order to the requestor
section 607 of the Food and Drug classifying the device into class I. FDA ■ 1. The authority citation for part 882
Administration Safety and Innovation is codifying the classification of the continues to read as follows:
Act (Pub. L. 112–144), provides two device by adding 21 CFR 882.1561. Authority: 21 U.S.C. 351, 360, 360c, 360e,
procedures by which a person may The device is assigned the generic 360j, 371.
request FDA to classify a device under name evoked photon image capture
the criteria set forth in section 513(a)(1). ■ 2. Add § 882.1561 to subpart B to read
device, and it is identified as a as follows:
Under the first procedure, the person prescription, electrically-powered
submits a premarket notification under device intended for use as a non- § 882.1561 Evoked photon image capture
section 510(k) of the FD&C Act for a invasive measurement tool that applies device.
device that has not previously been electricity to detect electrophysiological (a) Identification. An evoked photon
classified and, within 30 days of signals emanating from the skin, which image capture device is a prescription,
receiving an order classifying the device are reported numerically and as images electrically powered device intended for
into class III under section 513(f)(1), the without clinical interpretation. The use as a noninvasive measurement tool
person requests a classification under device is not intended for diagnostic that applies electricity to detect
section 513(f)(2). Under the second purposes. electrophysiological signals emanating
procedure, rather than first submitting a from the skin, which are reported
premarket notification under section FDA has identified the following risks
to health associated specifically with numerically and as images without
510(k) and then a request for clinical interpretation. The device is not
classification under the first procedure, this type of device: Adverse tissue
reaction, electromagnetic intended for diagnostic purposes.
the person determines that there is no (b) Classification. Class I (general
legally marketed device upon which to incompatibility, and electromagnetic
malfunction (e.g., shock). controls). The device is exempt from the
base a determination of substantial premarket notification procedures in
asabaliauskas on DSK3SPTVN1PROD with RULES
equivalence and requests a classification Evoked photon image capture devices subpart E of part 807 of this chapter,
under section 513(f)(2) of the FD&C Act. are not safe for use except under the subject to the limitations in § 882.9.
If the person submits a request to supervision of a practitioner licensed by
classify the device under this second law to direct the use of the device. As Dated: September 26, 2016.
procedure, FDA may decline to such, the device is a prescription device Leslie Kux,
undertake the classification request if and must satisfy prescription labeling Associate Commissioner for Policy.
FDA identifies a legally marketed device requirements (see 21 CFR 801.109 [FR Doc. 2016–23633 Filed 9–29–16; 8:45 am]
that could provide a reasonable basis for Prescription devices). BILLING CODE 4164–01–P
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Document Created: 2018-02-09 13:33:27
Document Modified: 2018-02-09 13:33:27
| 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 September 30, 2016. The classification was applicable on July 15, 2016. | |
| 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, [email protected] | |
| FR Citation | 81 FR 67154 | |
| CFR Associated | Medical Devices and Neurological Devices |
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