80 FR 48868 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 157 (August 14, 2015)

Page Range		48868-48869
FR Document		2015-20005

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements,'' which updates an earlier guidance of the same title published in the Federal Register on July 1, 2015. 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. Due to an administrative error, certain comments to this Docket were not considered prior to the July 1, 2015, guidance publication. These comments have now been considered. FDA believes additional devices and product codes are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness. As such, FDA is updating and adding these to the guidance.

Federal Register, Volume 80 Issue 157 (Friday, August 14, 2015)

[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48868-48869]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-20005]

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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.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Intent to Exempt Certain
Unclassified, Class II, and Class I Reserved Medical Devices from
Premarket Notification Requirements,'' which updates an earlier
guidance of the same title published in the Federal Register on July 1,
2015. 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. Due to an
administrative error, certain comments to this Docket were not
considered prior to the July 1, 2015, guidance publication. These
comments have now been considered. FDA believes additional devices and
product codes are sufficiently well understood and do not require
premarket notification to assure their safety and effectiveness. As
such, FDA is updating and adding these to the guidance.

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.

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
(21 U.S.C. 360(l))) from premarket notification requirements. FDA
believes the devices and product codes being added to 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 55 sets of comments on the draft
guidance. FDA published a final guidance on July 1, 2015 (80 FR 37633).
However, due to an administrative error, certain comments were not
considered prior to the July 1, 2015, guidance publication. These
comments have now been considered, and, based on that review, FDA is
updating and adding certain devices and product codes to the guidance.
These comments requested that FDA include approximately 390
additional product codes in the guidance. Of these product codes, more
than 110 were ones regulated by the Office of In Vitro Diagnostics and
Radiological Health, which were outside of the scope of FDA's review to
identify low-risk devices to ultimately exempt from premarket
notification requirements. Additionally, for approximately 75 of the
product codes, the comments noted that additional controls, such as
conformance to recognized standards, would be necessary if 510(k)s were
not submitted for these devices. Because the imposition of such
controls would go beyond the scope of this guidance, FDA is not adding
these device types and product codes to the guidance.
The comments also requested the addition of 18 product codes to the
guidance that were either already in the final guidance published on
July 1, 2015, exempt from premarket notification, or for which FDA is
currently exercising enforcement discretion (Ref. 1). For example, more
than 30 comments spoke to the inclusion of product code NUQ (Pad,
Menstrual, Reusable), which was included in the draft guidance
document, and remained in the final guidance document issued July 1,
2015.
FDA has considered the remaining product codes proposed in the
comments and has determined that the following eight additional product
codes should be included in the guidance document: Product code DTL,
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (see 21
CFR 870.4290--Cardiopulmonary bypass adaptor, stopcock, manifold, or
fitting); product code OCY, Endoscopic Guidewire, Gastroenterology-
urology (see 21 CFR 876.1500--Endoscope and accessories); product code
KOE, Dilator, urethral (see 21 CFR 876.5520--Urethral dilator); product
code FTA, Light, Surgical, Accessories (see 21 CFR 878.4580--Surgical
lamp); product code GZM, Analyzer, Rigidity (see 21 CFR 882.1020--
Rigidity analyzer); product code GZO, Device, Galvanic Skin Response
Measurement (see 21 CFR 882.1540--Galvanic skin response measurement
device); product code HCJ, Device, Skin Potential Measurement (see 21
CFR 882.1560--Skin potential measurement device);

[[Page 48869]]

and product code HLJ, Ophthalmoscope, Battery-powered (see 21 CFR
886.1570--Ophthalmoscope). FDA has determined it is appropriate to add
these product codes to the guidance because FDA has tentatively
concluded they are sufficiently well understood and do not require
premarket notification (510(k)) to assure their safety and
effectiveness.
Seven comments also requested the removal or clarification of
specific product codes in the draft guidance. The issues raised in
these comments were addressed by the removal of certain product codes
from the draft guidance, and the clarification of two product codes:
Product code MRQ, Analyzer, Nitrogen Dioxide; and product code KKX,
Drape, Surgical. Moreover, in response to the issues raised, FDA is
clarifying that it is not the Agency's intent to exempt combination
products or single entity products containing antimicrobial agents. For
the remaining product codes identified in those comments, FDA believes
that the product codes are sufficiently well understood and do not
require premarket notification (510(k)) to assure their safety and
effectiveness. Thus, FDA has not removed these products codes from the
guidance.

II. 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 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.

III. 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 Center for Devices and Radiological Health 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.

IV. 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
approved under OMB control number 0910-0120.

V. 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.

VI. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses in this reference section, but
we are not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.)
1. FDA announced that it would exercise enforcement discretion for
premarket notification for the following product codes, among others,
if the devices meet the criteria set forth in guidance: OFX, OKF, OKG,
OKH, OKI, LRO, and OJW. See Convenience Kits Interim Regulatory
Guidance (May 1997), available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.

Dated: August 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20005 Filed 8-13-15; 8:45 am]
BILLING CODE 4164-01-P

48868 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices

amendment will be made to 21 CFR SUPPLEMENTARY INFORMATION section for 2015 (80 FR 37633). However, due to an
14.100. information on electronic access to the administrative error, certain comments
This document is issued under the guidance. Submit written requests for a were not considered prior to the July 1,
Federal Advisory Committee Act (5 single hard copy of the guidance 2015, guidance publication. These
U.S.C. app. 2). For general information document entitled ‘‘Intent to Exempt comments have now been considered,
related to FDA advisory committees, Certain Unclassified, Class II, and Class and, based on that review, FDA is
please visit us at http://www.fda.gov/ I Reserved Medical Devices from updating and adding certain devices
AdvisoryCommittees/default.htm. Premarket Notification Requirements’’ and product codes to the guidance.
Dated: August 10, 2015. to the Office of the Center Director, These comments requested that FDA
Guidance and Policy Development, include approximately 390 additional
Jill Hartzler Warner,
Center for Devices and Radiological product codes in the guidance. Of these
Associate Commissioner for Special Medical product codes, more than 110 were ones
Programs. Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, regulated by the Office of In Vitro
[FR Doc. 2015–20050 Filed 8–13–15; 8:45 am] Diagnostics and Radiological Health,
Rm. 5431, Silver Spring, MD 20993–
BILLING CODE 4164–01–P
0002. Send one self-addressed adhesive which were outside of the scope of
label to assist that office in processing FDA’s review to identify low-risk
your request. devices to ultimately exempt from
DEPARTMENT OF HEALTH AND premarket notification requirements.
HUMAN SERVICES Submit electronic comments on the
guidance to http://www.regulations.gov. Additionally, for approximately 75 of
Submit written comments to the the product codes, the comments noted
Food and Drug Administration
Division of Dockets Management (HFA– that additional controls, such as
[Docket No. FDA–2014–D–0967] 305), Food and Drug Administration, conformance to recognized standards,
5630 Fishers Lane, Rm. 1061, Rockville, would be necessary if 510(k)s were not
Intent To Exempt Certain Unclassified, submitted for these devices. Because the
MD 20852. Identify comments with the
Class II, and Class I Reserved Medical imposition of such controls would go
docket number found in brackets in the
Devices From Premarket Notification beyond the scope of this guidance, FDA
heading of this document.
Requirements; Guidance for Industry is not adding these device types and
and Food and Drug Administration FOR FURTHER INFORMATION CONTACT:
product codes to the guidance.
Staff; Availability Angela C. Krueger, Center for Devices The comments also requested the
and Radiological Health, Food and Drug addition of 18 product codes to the
AGENCY: Food and Drug Administration, Administration, 10903 New Hampshire
HHS. guidance that were either already in the
Ave., Bldg. 66, Rm. 1666, Silver Spring, final guidance published on July 1,
ACTION: Notice. MD 20993–0002, 301–796–6380. 2015, exempt from premarket
SUPPLEMENTARY INFORMATION: notification, or for which FDA is
SUMMARY: The Food and Drug
Administration (FDA) is announcing the I. Background currently exercising enforcement
availability of a guidance entitled discretion (Ref. 1). For example, more
In the commitment letter (section 1.G than 30 comments spoke to the
‘‘Intent to Exempt Certain Unclassified, of the Performance Goals and
Class II, and Class I Reserved Medical inclusion of product code NUQ (Pad,
Procedures) that was drafted as part of Menstrual, Reusable), which was
Devices from Premarket Notification the reauthorization process for the
Requirements,’’ which updates an included in the draft guidance
Medical Device User Fee Amendments document, and remained in the final
earlier guidance of the same title of 2012, part of the Food and Drug
published in the Federal Register on guidance document issued July 1, 2015.
Administration Safety and Innovation FDA has considered the remaining
July 1, 2015. This guidance describes Act (Pub. L. 112–144), FDA committed product codes proposed in the
FDA’s intent to exempt certain to identifying low-risk medical devices comments and has determined that the
unclassified medical devices (that FDA to exempt from premarket notification following eight additional product
intends to classify into class I or II), requirements. This guidance describes codes should be included in the
certain class II medical devices, and FDA’s intent to exempt certain guidance document: Product code DTL,
certain class I medical devices from unclassified medical devices (that FDA Adaptor, Stopcock, Manifold, Fitting,
premarket notification requirements. intends to classify into class I or II), Cardiopulmonary Bypass (see 21 CFR
Due to an administrative error, certain certain class II medical devices, and 870.4290—Cardiopulmonary bypass
comments to this Docket were not certain class I medical devices (that no adaptor, stopcock, manifold, or fitting);
considered prior to the July 1, 2015, longer meet the ‘‘reserved’’ criteria in product code OCY, Endoscopic
guidance publication. These comments section 510(l) of the Federal Food, Drug, Guidewire, Gastroenterology-urology
have now been considered. FDA and Cosmetic Act (21 U.S.C. 360(l))) (see 21 CFR 876.1500—Endoscope and
believes additional devices and product from premarket notification accessories); product code KOE, Dilator,
codes are sufficiently well understood requirements. FDA believes the devices urethral (see 21 CFR 876.5520—Urethral
and do not require premarket and product codes being added to this dilator); product code FTA, Light,
notification to assure their safety and guidance document are sufficiently well Surgical, Accessories (see 21 CFR
effectiveness. As such, FDA is updating understood and do not require 510(k) 878.4580—Surgical lamp); product code
and adding these to the guidance. notification to assure their safety and GZM, Analyzer, Rigidity (see 21 CFR
asabaliauskas on DSK5VPTVN1PROD with NOTICES

DATES: Submit either electronic or effectiveness. 882.1020—Rigidity analyzer); product
written comments on this guidance at The draft of this guidance was made code GZO, Device, Galvanic Skin
any time. General comments on Agency available in the Federal Register on Response Measurement (see 21 CFR
guidance documents are welcome at any August 1, 2014 (79 FR 44804). The 882.1540—Galvanic skin response
time. comment period closed on September measurement device); product code
ADDRESSES: An electronic copy of the 30, 2014. FDA received 55 sets of HCJ, Device, Skin Potential
guidance document is available for comments on the draft guidance. FDA Measurement (see 21 CFR 882.1560—
download from the Internet. See the published a final guidance on July 1, Skin potential measurement device);

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Document Created: 2018-02-23 10:58:51
Document Modified: 2018-02-23 10:58:51

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		Notices
Action		Notice.
Dates		Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
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.
FR Citation		80 FR 48868

80 FR 48868 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 157 (August 14, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration