U.S. Congress - H.R.3203 Novel Device Regulatory Relief Act of 2011
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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Official Summary
10/14/2011--Introduced.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 fiOfficial Summary
10/14/2011--Introduced.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....Read the Rest
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