Regulatory Focus™ > News Articles > FDA Releases New Draft Guidance on Medical Device Classification Product Codes

FDA Releases New Draft Guidance on Medical Device Classification Product Codes

Posted 03 January 2012 | By Alexander Gaffney, RAC 

The FDA released new draft guidance for industry on Tuesday titled, Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes.

Classification product codes are used by FDA to help identify, track, and reference medical device types. They are standardized alphanumeric strings used to quickly identify the product's characteristics, device class, and predicate devices.

The purpose of the draft guidance is to educate industry and FDA staff on the proper use of classification product code for medical devices regulated by CDRH and CBER.

The draft guidance, previously referenced by Jeffery Shuren in a posting on the new FDA Voice blog, comes on the heels of new 510(k) draft guidance and new guidance on appealing CDRH decisions.

Comments on the draft guidance are due in early April (120 days).

(FDA - Draft Guidance)

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