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FDA proposes improvements to the De Novo pathway
- https://www.fda.gov/news-events/fda-brief/fda-brief-fda-proposes-improvements-de-novo-pathway-novel-medical-devices-advance-safe-effective-and
- The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and …
S. 2067 (112 th ): Safe, Efficient, and Transparent …
- https://www.govtrack.us/congress/bills/112/s2067/text
- S. 2067 (112 th): Safe, Efficient, and Transparent Medical Device Approval Act React to this bill with an emoji Save your opinion on this bill on a six-point scale from strongly …
Safe, Efficient, and Transparent Medical Device Approval …
- https://www.govtrack.us/congress/bills/112/s2067
- This bill was introduced on February 2, 2012, in a previous session of Congress, but it did not receive a vote. Although this bill was not enacted, its provisions …
S. 2067 (112 th ): Safe, Efficient, and Transparent …
- https://www.govtrack.us/congress/bills/112/s2067/text/is
- S. 2067 (112 th): Safe, Efficient, and Transparent Medical Device Approval Act React to this bill with an emoji Save your opinion on this bill on a six-point scale from strongly …
S.2067: SET Device Act | Represent | ProPublica
- https://projects.propublica.org/represent/bills/112/s2067
- Sponsored by Bob Casey D-Pa. Introduced to the Senate on Feb. 2, 2012 -- Safe, Efficient, and Transparent Medical Device Approval Act or the SET Device Act - Directs …
Medical Device Safety Action Plan: Protecting Patients, …
- https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health
- In the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, the FDA describes key actions it will take in the following areas: Establish a robust medical …
A History of Medical Device Regulation and Oversight in …
- https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states
- 1906: Pure Food and Drugs Act (sometimes also called the Federal Food and Drugs Act) Established the precursor to today’s FDA Prohibited interstate commerce of misbranded …
Senators Introduce Bipartisan Bill to Streamline Medical …
- https://www.theregreview.org/2012/02/16/senators-introduce-bipartisan-bill-to-streamline-medical-device-approval/
- Senators Robert Casey (D-PA) and John McCain (R-AZ) recently introduced a bipartisan bill intended to streamline the regulatory approval process for medical …
H.R.3095 - Safe Medical Devices Act of 1990 - Congress
- https://www.congress.gov/bill/101st-congress/house-bill/3095
- Allows the Secretary to grant an exemption from certain effectiveness requirements for a device for which the Secretary finds that: (1) it is designed to treat or diagnose a disease …
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