[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.
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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 [email protected] 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
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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]
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