Want to Reclassify a Medical Device? The FDA is all Ears

Jane Akre
November 15, 2011

The Food and Drug Administration on Monday, November 14, announced it will receive public comment on whether or not a medical device should be reclassified to require more or less regulatory oversight.

There are three classes of medical devices – Class I are considered low risk, Class II are moderate risk devices and Class III have the highest risk.

The public comment period will remain open to January 13, 2012. Regulators are trying to make the approval process easier in that they receive about 4,000 applications for 510(k) every year with about three-quarters approved.

According to an article in MassDevice, (here) “The agency is also looking for ideas on how to use automated collection techniques and other forms of information technology to make the submission process easier.”

Suggestions and comments must be sent to the FDA by January 13, 2012, according to the Federal Register announcement (here)

How to Contact FDA:

Submit electronic comments on the collection of information

to http://www.regulations.gov. Submit written comments on the

collection of information to the Division of Dockets Management (HFA-

305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852. All comments should be identified with the docket

number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office ofInformation Management, Food and Drug Administration, 1350 Piccard Dr.,PI50-400B, Rockville, MD 20850, (301) 796-5156,Daniel.Gittleson@fda.hhs.gov.


Under the Federal Food, Drug, and Cosmetic Act, anyone can petition to have a medical device reclassified. Expect manufacturers to try and take advantage of reclassification in that lowering your device from a Class III to Class II means the manufacturer can introduce similar products to the marketplace more quickly.

The FDA estimates six petitions for reclassification will be received this year and it takes staff about 500 hours to review the supporting data. #

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