Official Summary

12/5/2011--Introduced.Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to allow a person to request the Secretary of Health and Human Services (HHS) to classify a device regardless of whether the person has received written notice of classificati

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Official Summary

12/5/2011--Introduced.Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to allow a person to request the Secretary of Health and Human Services (HHS) to classify a device regardless of whether the person has received written notice of classification into class III (premarket approval) under the initial classification procedures applicable to devices introduced or delivered for introduction into interstate commerce before May 28, 1976. Allows a person that is required to submit a report preceding the introduction of device into interstate commerce, and determines that there is no legally marketed device upon which to base a determination of substantial equivalence, to request an initial classification of the device and to recommend to the Secretary a classification. Allows the Secretary to decline to undertake such a request when the Secretary identifies a legally marketed device that would permit a determination of substantial equivalence.

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