FDA update January 4, 2012

Draft Guidance for Medical Device Classification Product Codes

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 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

• 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 & Cosmetic (FD&C) Act and Does not discuss classification product codes used to regulate non-medical electronic Radiation emitting products.

• The scope of this document includes devices described in the existing classifications under 21 CFR Parts 862-892. It also describes how the product code builder developed by FDA’s Office of Regulatory Affairs is used for devices that are licensed under the Public Health Service Act (PHS Act), and currently do not have product codes generated under Classification regulation panels. It also covers unclassified devices and devices not yet Classified.

Since the May 28, 1976 Medical Device Amendments were passed, the Classification Regulation Panels (21 CFR 862-892) have been the basis for the Center for Devices and Radiological Health’s (CDRH) 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 there have been few additions or modifications to the Panels and sub-groups 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 used by FDA to obtain quality and reliable data, perform analysis that is often reported to Congress, the Government Accountability Office (GAO), the general public, the press, and industry. Classification product codes are also used throughout the total product life cycle (TPLC) as they connect all medical device databases.

Classification product codes are a method of classifying medical devices. CDRH and a Subset of CBER regulated medical device product codes consist of a 3 letter combination Which 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.

PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA  consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FDA-2011-D-0916.

Or you can send your comments Before  May 2 2012 at info@mdiconsultants.com and REF:Medical Device Classification Product Codes.

For more information on this guidance you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM285325.pdf.