82 FR 47373 - Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 196 (October 12, 2017)

Page Range		47373-47373
FR Document		2017-21982

The Food and Drug Administration (FDA) is correcting a final order entitled ``Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device'' that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.

Federal Register, Volume 82 Issue 196 (Thursday, October 12, 2017)

[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Rules and Regulations]
[Page 47373]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21982]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2017-N-1608]


Medical Devices; Neurological Devices; Classification of Cranial 
Motion Measurement Device; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
order entitled ``Medical Devices; Neurological Devices; Classification 
of Cranial Motion Measurement Device'' that appeared in the Federal 
Register of July 28, 2017. The final order was published with an 
incorrect statement in the preamble about whether FDA planned to exempt 
the device from premarket notification requirements. This document 
corrects that error.

DATES: Effective October 12, 2017.

FOR FURTHER INFORMATION CONTACT: Jay Gupta, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2611, Silver Spring, MD 20993-0002, 301-796-2795, 
jay.gupta@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 28, 2017 (82 
FR 35069), FDA published the final order ``Medical Devices; 
Neurological Devices; Classification of Cranial Motion Measurement 
Device.'' The final order published with an incorrect statement in the 
preamble about whether FDA planned to exempt the device from premarket 
notification requirements under section 510(k) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)).

Correction

    In the Federal Register of July 28, 2017, in FR Doc. 2017-15895, 
the following correction is made:

    On page 35070, after table 1 in the third column, the last 
paragraph is corrected to read as follows:
    ``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), 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 cranial 
motion measurement device they intend to market.''

    Dated: October 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21982 Filed 10-11-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Rules and Regulations 47373

for that affected control surface, unless the March 9, 2017 for related information. You final order entitled ‘‘Medical Devices;
FAA-approved repair instructions specify may examine the MCAI on the Internet at Neurological Devices; Classification of
otherwise. https://www.regulations.gov/
Cranial Motion Measurement Device’’
(6) Replacement of the affected part on an document?D=FAA-2017-0648-0002.
airplane with a part listed in table 1 of PAI that appeared in the Federal Register of
(i) Material Incorporated by Reference July 28, 2017. The final order was
SB No. 80–0455, constitutes terminating
action for the repetitive inspections required (1) The Director of the Federal Register published with an incorrect statement
by this AD for that part. approved the incorporation by reference in the preamble about whether FDA
(7) You may incorporate the actions of PAI (IBR) of the service information listed in this planned to exempt the device from
SB No. 80–0455, into your FAA-approved paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51. premarket notification requirements.
airplane inspection program (AIP) or
maintenance program (instructions for (2) You must use this service information This document corrects that error.
continued airworthiness) to ensure the as applicable to do the actions required by DATES: Effective October 12, 2017.
continuing airworthiness of each operated this AD, unless this AD specifies otherwise.
airplane. (i) PIAGGIO AERO INDUSTRIES S.p.A. FOR FURTHER INFORMATION CONTACT: Jay
(8) After November 16, 2017 (the effective Mandatory Service Bulletin (SB) No.: 80– Gupta, Center for Devices and
date of this AD), you may install on an 0455, dated January 13, 2017.
Radiological Health, Food and Drug
airplane an affected control surface not listed (ii) Reserved.
(3) For PIAGGIO AERO INDUSTRIES Administration, 10903 New Hampshire
in table 1 of PAI SB No. 80–0455, provided
that before further flight after installation, the S.p.A. service information identified in this Ave., Bldg. 66, Rm. 2611, Silver Spring,
affected control surface has been inspected as AD, contact PIAGGIO AERO INDUSTRIES MD 20993–0002, 301–796–2795,
specified in this AD and found airworthy. S.p.A.—Continued Airworthiness, Via jay.gupta@fda.hhs.gov.
Pionieri e Aviatori d’Italia snc—16154
(g) Other FAA AD Provisions Genova, Italy; Telephone: +39 010 0998046; SUPPLEMENTARY INFORMATION: In the
The following provisions also apply to this Fax: None; email: airworthiness@ Federal Register of July 28, 2017 (82 FR
AD: piaggioaerospace.it; Internet: 35069), FDA published the final order
(1) Alternative Methods of Compliance www.piaggioaerospace.it/en/customer- ‘‘Medical Devices; Neurological Devices;
(AMOCs): The Manager, Standards Office, support#care. Classification of Cranial Motion
FAA, has the authority to approve AMOCs (4) You may view this service information
at the FAA, Policy and Innovation Division,
Measurement Device.’’ The final order
for this AD, if requested using the procedures
found in 14 CFR 39.19. Send information to 901 Locust, Kansas City, Missouri 64106. For published with an incorrect statement
ATTN: Mike Kiesov, Aerospace Engineer, information on the availability of this in the preamble about whether FDA
FAA, Small Airplane Standards Branch, 901 material at the FAA, call (816) 329–4148. In planned to exempt the device from
Locust, Room 301, Kansas City, Missouri addition, you can access this service premarket notification requirements
64106; telephone: (816) 329–4144; fax: (816) information on the Internet at http:// under section 510(k) of the Federal
329–4090; email: mike.kiesov@faa.gov. www.regulations.gov by searching for and
Food, Drug, and Cosmetic Act (the
Before using any approved AMOC on any locating Docket No. FAA–2017–0648.
(5) You may view this service information FD&C Act) (21 U.S.C. 360(k)).
airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in that is incorporated by reference at the Correction
the FAA Flight Standards District Office National Archives and Records
(FSDO), or lacking a PI, your local FSDO. Administration (NARA). For information on In the Federal Register of July 28,
(2) Contacting the Manufacturer: For any the availability of this material at NARA, call
2017, in FR Doc. 2017–15895, the
requirement in this AD to obtain corrective 202–741–6030, or go to: http://
www.archives.gov/federal-register/cfr/ibr- following correction is made:
actions from a manufacturer, the action must
be accomplished using a method approved locations.html. On page 35070, after table 1 in the third
by the Manager, Small Airplane Standards Issued in Kansas City, Missouri, on column, the last paragraph is corrected to
Branch, FAA; or the European Aviation September 29, 2017. read as follows:
Safety Agency (EASA). ‘‘Section 510(m) of the FD&C Act provides
Pat Mullen,
(3) Reporting Requirements: For any that FDA may exempt a class II device from
reporting requirement in this AD, a federal Acting Deputy Director, Policy & Innovation
Division, Aircraft Certification Service. the premarket notification requirements
agency may not conduct or sponsor, and a
under section 510(k), if FDA determines that
person is not required to respond to, nor [FR Doc. 2017–21443 Filed 10–11–17; 8:45 am]
shall a person be subject to a penalty for premarket notification is not necessary to
BILLING CODE 4910–13–P
failure to comply with a collection of provide reasonable assurance of the safety
information subject to the requirements of and effectiveness of the device. For this type
the Paperwork Reduction Act unless that of device, FDA has determined that
collection of information displays a current DEPARTMENT OF HEALTH AND premarket notification is necessary to
valid OMB Control Number. The OMB HUMAN SERVICES provide reasonable assurance of the safety
Control Number for this information and effectiveness of the device. Therefore,
collection is 2120–0056. Public reporting for Food and Drug Administration
this device type is not exempt from
this collection of information is estimated to premarket notification requirements. Persons
be approximately 5 minutes per response, 21 CFR Part 882 who intend to market this type of device
including the time for reviewing instructions,
[Docket No. FDA–2017–N–1608] must submit to FDA a premarket notification,
completing and reviewing the collection of
information. All responses to this collection prior to marketing the device, which contains
of information are mandatory. Comments Medical Devices; Neurological information about the cranial motion
concerning the accuracy of this burden and Devices; Classification of Cranial measurement device they intend to market.’’
suggestions for reducing the burden should Motion Measurement Device;
Dated: October 4, 2017.
jstallworth on DSKBBY8HB2PROD with RULES

be directed to the FAA at: 800 Independence Correction
Ave. SW., Washington, DC 20591, Attn: Leslie Kux,
Information Collection Clearance Officer, AGENCY: Food and Drug Administration, Associate Commissioner for Policy.
AES–200. HHS. [FR Doc. 2017–21982 Filed 10–11–17; 8:45 am]
ACTION: Final order; correction.
(h) Related Information BILLING CODE 4164–01–P

Refer to MCAI European Aviation Safety SUMMARY: The Food and Drug
Agency (EASA) AD No.: 2017–0045, dated Administration (FDA) is correcting a

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Document Created: 2018-10-25 10:02:55
Document Modified: 2018-10-25 10:02:55

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; correction.
Dates		Effective October 12, 2017.
Contact		Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2611, Silver Spring, MD 20993-0002, 301-796-2795, [email protected]
FR Citation		82 FR 47373

82 FR 47373 - Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 196 (October 12, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration