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FDA Issues Draft Guidance on De Novo Classification Process by Edward M. Basile
King & Spalding LLP - Washington Office
Joanne H. Chan
King & Spalding LLP - Washington Office
Laurie A. Clarke
King & Spalding LLP - Washington Office
Elaine H. Tseng
King & Spalding LLP - San Francisco Office
Lynette A. Zentgraft
King & Spalding LLP - Washington Office
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October 10, 2011
Previously published on October 5, 2011
On October 3, 2011, FDA issued a draft guidance entitled, “De Novo Classification Process (Evaluation of Automatic Class III Designation).” In the guidance, FDA described the submission and review of petitions under the de novo classification process in section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act. Under the de novo process, a low to moderate risk medical device that FDA found to be not substantially equivalent (“NSE”) to a legally marketed predicate device based on a 510(k) notice can be reclassified from Class III to Class I or Class II. Reclassification allows immediate marketing of the device that is the subject of the de novo review petition (“the new device”) and its use as a predicate device.
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