[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Notices]
[Pages 21612-21613]
From the Federal Register Online via the Government Printing 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 dsmica@fda.hhs.gov 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

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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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