Document ID: FDA-2014-D-0967-0004
Agency: fda
Document Type: Notice
Title: Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2015-07-01T04:00Z

[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37633-37635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16150]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0967]

Intent to Exempt Certain Unclassified, Class II, and Class I 
Reserved Medical Devices From Premarket Notification Requirements; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Intent to Exempt Certain 
Unclassified, Class II, and Class I Reserved Medical Devices from 
Premarket Notification Requirements.'' This guidance describes FDA's 
intent to exempt certain unclassified medical devices (that FDA intends 
to classify into class I or II), certain class II medical devices, and 
certain class I medical devices from premarket notification 
requirements. FDA believes the devices identified in this guidance 
document are sufficiently well understood and do not require premarket 
notification to assure their safety and effectiveness.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved 
Medical Devices from Premarket Notification Requirements'' to the 
Office of the Center Director, Guidance and Policy Development, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

[[Page 37634]]

FOR FURTHER INFORMATION CONTACT: Angela C. Krueger, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-
796-6380.

SUPPLEMENTARY INFORMATION:

I. Background

    In the commitment letter (section 1.G of the Performance Goals and 
Procedures) that was drafted as part of the reauthorization process for 
the Medical Device User Fee Amendments of 2012, part of the Food and 
Drug Administration Safety and Innovation Act (Pub. L. 112-144), FDA 
committed to identifying low-risk medical devices to exempt from 
premarket notification requirements. This guidance describes FDA's 
intent to exempt certain unclassified medical devices (that FDA intends 
to classify into class I or II), certain class II medical devices, and 
certain class I medical devices (that no longer meet the ``reserved'' 
criteria in section 510(l) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 360(l))) from premarket notification 
requirements. FDA believes the devices identified in this guidance 
document are sufficiently well understood and do not require 510(k) 
notification to assure their safety and effectiveness.
    The draft of this guidance was made available in the Federal 
Register on August 1, 2014 (79 FR 44804). The comment period closed on 
September 30, 2014. FDA received one comment on the draft guidance 
requesting that devices classified under 21 CFR 880.6760 (Protective 
restraint, product code OYS, Patient Bed with Canopy/Restraints) be 
considered for inclusion in the guidance document. FDA considered the 
comment and determined it was appropriate to add this device type to 
the final guidance.
    In the process of finalizing the guidance document, the Center for 
Devices and Radiological Health (CDRH) reviewed additional medical 
device product codes not included in the draft guidance and determined 
that there were additional device types which are sufficiently well 
understood and do not require premarket notification (510(k)) to assure 
their safety and effectiveness. As a result, the following device types 
(product codes) were added to the final guidance document: EIB--
Syringe, Irrigating (Dental); EWD--Protector, Hearing (Insert); EWE--
Protector, Hearing (Circumaural); LEZ--Aids, Speech Training for the 
Hearing Impaired (AC-Powered and Patient-Contact); LFA--Aids, Speech 
Training for the Hearing Impaired (Battery-Operated or Non-Patient); 
KLX--Electroglottograph; LZI--Device, Assistive Listening; LRL--
Cushion, Hemorrhoid; KMJ--Lubricant, Patient; OYS--Patient Bed with 
Canopy/Restraint (see above); HCD--Cannula, Ventricular; GYK--
Instrument, Shunt System Implantation; LHM--System, Thermographic, 
Liquid Crystal; KYA--System, Thermographic, Liquid Crystal, Nonpowered 
(Adjunctive Use); NUR--Pad, Interlabial; and LZW--Monitor, Spine 
Curvature.
    Additionally, CDRH reviewed the device types (product codes) 
included in the draft guidance document and determined that two device 
types (product codes) originally proposed in the draft guidance 
document should not be included in the final guidance as devices for 
which FDA intends to exempt from premarket notification requirements: 
FLL--Thermometer, Electrical, Clinical (21 CFR 880.2910); and GWO--
Plate, Cranioplasty, Preformed, Alterable (21 CFR 882.5320). CDRH 
determined that premarket notification (510(k)) is necessary to assure 
the safety and effectiveness of these devices. Notably, the FLL product 
code currently covers thermometers with a range of technologies and 
intended uses, including those used to screen for potential pandemic 
contagious diseases. CDRH believes that some thermometer types may be 
candidates for exemption from premarket notification requirements at a 
later date, but that thermometers should first be further categorized 
by technology and/or intended use into distinct product codes. CDRH is 
actively reviewing this issue and will further consider which of the 
sub-types may be appropriate to exempt from premarket notification 
requirements. In addition, CDRH believes that premarket notification 
(510(k)) is necessary to provide a reasonable assurance of safety and 
effectiveness for cranioplasty plates (GWO), which are permanent 
implants and may be constructed of polymeric materials and/or may be 
resorbable, because FDA must evaluate the material properties and 
resorption rate in relation to bone healing. CDRH recognizes that 
manufacturers may not have submitted a 510(k) for these two device 
types following publication of the draft guidance. As a result, CDRH is 
providing such manufacturers 90 days following the publication of this 
notice to submit a 510(k) for these device types; however, distribution 
and marketing of such devices must cease if a manufacturer receives an 
order from FDA declaring the device to be not substantially equivalent 
to any legally marketed predicate device. Finally, CDRH changed the 
product code listed in the guidance document for Ophthalmic Cameras (21 
CFR 886.1120) from HKI--Camera, Ophthalmic, AC-Powered to PJZ--Camera, 
Ophthalmic, AC-Powered, General Use to clarify the type of AC-powered 
Ophthalmic Camera CDRH intended to exempt. CDRH also removed LQX--
Device, Finger-Sucking (21 CFR 890.3475) from the final guidance 
because this device type is already classified as class I (general 
controls) and exempt from premarket notification. Finger-sucking 
devices (LQX) and cranioplasty plates (GWO) were unintentionally 
included in the draft guidance.

III. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of the FDA on the Intent to Exempt Certain 
Unclassified, Class II, and Class I Reserved Medical Devices from 
Premarket Notification Requirements. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

IV. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of 
``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved 
Medical Devices from Premarket Notification Requirements'' may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1300046 to 
identify the guidance you are requesting.

V. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in 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 21 CFR part 807, subpart E, have been

[[Page 37635]]

approved under OMB control number 0910-0120.

VI. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
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.

    Dated: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16150 Filed 6-30-15; 8:45 am]
BILLING CODE 4164-01-P