H.R. 3203 · 112th Congress
Novel Device Regulatory Relief Act of 2011
- Stage
- In committee
- Sponsor
- Brian Bilbray
- Introduced
- 2011-10-14
- Latest action
- 2011-10-18 · Referred to the Subcommittee on Health.
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.