H.R.3203 - Novel Device Regulatory Relief Act of 2011

To amend section 513 of the Federal Food, Drug, and Cosmetic Act to expedite the process for requesting de novo classification of a device. view all titles (2)

All Bill Titles

  • Official: To amend section 513 of the Federal Food, Drug, and Cosmetic Act to expedite the process for requesting de novo classification of a device. as introduced.
  • Short: Novel Device Regulatory Relief Act of 2011 as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
10/14/11
 
 
 
 
 
 
 

Sponsor

Representative

Brian Bilbray

R-CA

View Co-Sponsors (18)

Official Summary

Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the process for requesting classification for a type of medical device that has not been previously classified by removing the requirement that a person can only file a request for classif

Official Summary

Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the process for requesting classification for a type of medical device that has not been previously classified by removing the requirement that a person can only file a request for classification of a new medical device after the Secretary of Health and Human Services (HHS) classifies the device as a class III device in response to the person filing a notice of intent to market the device.

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