Notice: Draft Guidance for Industry and Food and Drug Administration 
Staff; Medical Device Classification Product Codes; Availability

Federal Register: Volume 77, Number 1 (Tuesday, January 3, 2012)
                  Pages 125-126

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Medical Device 
Classification Product Codes.'' The purpose of the 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 the 
Center for Devices and Radiological Health (CDRH) and the Center for 
Biologics Evaluation and Research (CBER). This document describes how 
classification product codes are used in a variety of FDA program areas 
to regulate and track medical devices. This draft guidance is not final 
nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 2, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Medical Device Classification Product 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 Office of Communication, Outreach and 
Development (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. Send one self-addressed 
adhesive label to assist that office in processing your request, or fax 
your request to CDRH at (301) 847-8149. The draft guidance may also be 
obtained by mail by calling CBER at (800) 835-4709 or (301) 827-1800. 
See the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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; and
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.

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 the 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. Relying on the Classification Regulation Panels structure, CDRH 
created classification product codes 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. Medical device product codes consist of a three-letter 
combination, which associates a device's type with a product 
classification. 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 the guidance document is to educate regulated 
industry and FDA Staff on how, when, and why to use classification 
product codes for medical devices 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 non-medical 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 also be applicable to future devices. 
It also covers unclassified devices and devices not yet classified.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 draft 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 the 
CBER Internet site 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

    Dated: December 28, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-33686 Filed 12-30-11; 8:45 am]
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