Novel Device Regulatory Relief Act of 2011

Summary

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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Timeline

1. 5 December 2011

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 5 December 2011

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 5 December 2011 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 5 December 2011

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 5 December 2011

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 5 December 2011

  Open at official source

Sponsors

• Sen. Brown, Scott P. [R-MA] · R · Sponsor
• Sen. Ayotte, Kelly [R-NH] · R · Sponsor
• · sshr00 · Standing

Related records

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