S. 1943 · 112th Congress
Novel Device Regulatory Relief Act of 2011
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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
BrownSponsor1 cosponsor · 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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…
What it does: CRS summary · Introduced in Senate · Dec 5, 2011
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Novel Device Regulatory Relief Act of 2011
Latest action (Dec 5, 2011): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Dec 5, 2011
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.