United States · Bill · HR
H.R. 3203 (112th)
Novel Device Regulatory Relief Act of 2011
Introduced
14 October 2011
Last action
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Status
Referred to the Subcommittee on Health.
Sponsors
—
Subjects
Discovery layer
Source updated
14 August 2025
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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Documents
3 official files
Introduced in House (text)
Introduced in House (text)
Introduced in House · EN · 14 October 2011
Introduced in House (PDF)
Introduced in House · EN · 14 October 2011
Introduced in House
summary · EN · 14 October 2011
Sponsors
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Sources
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- Official source: https://www.congress.gov/bill/112th-congress/house-bill/3203
- Open data entity: https://api.congress.gov/v3/bill/112/hr/3203