[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Notices]
[Pages 21612-21613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08442]
[[Page 21612]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0916]
Medical Device Classification Product Codes; 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 ``Medical Device Classification
Product Codes.'' This document describes how device product codes are
used in a variety of FDA program areas to regulate and track medical
devices regulated by the Center for Devices and Radiological Health
(CDRH) and the Center for Biologics Evaluation and Research (CBER).
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: Submit written requests for single copies of the guidance
document entitled ``Medical Device Classification Product Codes'' to
the Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002 or the Office of Communication, Outreach and
Development (HFM-40), 1401 Rockville Pike, suite 200N, Rockville, MD
20852. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to CDRH at 301-847-8149.
See the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.
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:
Diane Garcia, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1644, Silver
Spring, MD 20993-0002, 301-796-6559; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
Since the May 28, 1976, Medical Device Amendments were passed, the
Classification Regulation Panels (parts 862 through 892 (21 CFR parts
862 through 892)) have been the basis for CDRH's Classification Product
Code structure and organization. These 16 Panels have largely been the
driving force for CDRH's internal organizational structure as well.
These Panels were established with the 1976 Medical Device Amendments,
and rulemaking is required in order to add to or modify the Panels.
However, rulemaking has resulted in very few additions or modifications
to the Panels and subgroups since 1976.
In order to respond to the evolution of device technology,
classification product codes were created to assist in accurate
identification and tracking of current medical devices and to allow for
tracking and easy reference of predicate device types. Classification
product codes are a method of classifying medical devices. CDRH and a
subset of CBER-regulated medical device product codes consist of a
three-letter combination that associates a device's type with a product
classification designated for the application. Classification product
codes and information associated with these devices, such as names and
attributes, are assigned by CDRH to support their regulation.
The purpose of this guidance document is to educate regulated
industry and FDA Staff on how, when, and why to use classification
product codes for medical devices regulated by CDRH and CBER. This
document describes how classification product codes are used in a
variety of FDA program areas to regulate and track medical devices.
This document is limited to medical devices as defined in section
201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))
and does not discuss classification products codes used to regulate
nonmedical electronic radiation-emitting products.
The scope of the guidance document includes devices described in
the existing classification under parts 862 through 892. It also
describes how classification product codes are used for CBER regulated
devices, which currently do not fall within this existing
classification. This guidance may be applicable to future devices. It
also covers unclassified devices and devices not yet classified.
In the Federal Register of January 3, 2012 (77 FR 125), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by May 2, 2012. Five comments were
received with multiple recommendations pertaining to the administrative
processes and policies regarding medical device classification product
codes. In response to these comments, FDA revised the guidance document
to clarify the processes and policies as appropriate.
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
Agency's current thinking on medical device classification product
codes. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using 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 or from CBER
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Medical Device Classification Product Codes,'' you may either send an
email request to [email protected] to receive an electronic copy of
the document or send a fax request to 301-847-8149 to receive a hard
copy. Please use the document number 1774 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 803, subpart A through E,
have been approved under OMB control number 0910-0437; the collections
of information in 21 CFR part 807, subpart E, have been approved under
OMB control number 0910-0120; and the
[[Page 21613]]
collections of information under 21 CFR part 814 have been approved
under OMB control number 0910-0231.
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.
Dated: April 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08442 Filed 4-10-13; 8:45 am]
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