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Medical Devices — Balancing Regulation and Innovation …
- https://www.nejm.org/doi/full/10.1056/NEJMp1109094
- The Institute of Medicine has recommended eliminating a process that permits approval of a device based on its “substantial equivalence” to an existing device. Disclosure forms provided by the ...
Medical Devices — Balancing Regulation and Innovation …
- https://www.nejm.org/doi/full/10.1056/NEJMc1113164
- Medical Devices — Balancing Regulation and Innovation. To the Editor: The Perspective article by Curfman and Redberg (Sept. 15 issue) 1 is much too …
Medical devices--balancing regulation and innovation
- https://pubmed.ncbi.nlm.nih.gov/21830959/
- Medical devices--balancing regulation and innovation. Medical devices--balancing regulation and innovation N Engl J Med. 2011 Sep 15;365(11):975-7. doi: …
Medical Devices — Balancing Regulation and Innovation
- https://www.taylorfrancis.com/chapters/edit/10.4324/9781003074984-4/medical-devices-balancing-regulation-innovation-gregory-curfman-rita-redberg
- The manufacturer successfully made the case that the re-engineered implant was “substantially equivalent” to a predicate device. The subcommittee’s chairman, …
Medical devices--balancing regulation and innovation
- https://pubmed.ncbi.nlm.nih.gov/22256822/
- Medical devices--balancing regulation and innovation. Medical devices--balancing regulation and innovation N Engl J Med. 2012 Jan 19;366(3):280; author …
Medical Device Innovation Initiative White …
- https://www.fda.gov/about-fda/cdrh-innovation/medical-device-innovation-initiative-white-paper
- The Innovation Initiative proposes actions CDRH could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices …
Medical Devices - Balancing Regulation and Innovation
- https://www.researchgate.net/publication/51561202_Medical_Devices_-_Balancing_Regulation_and_Innovation
- 32 The regulation of medical devices is therefore intended to strike a pragmatic balance between bringing innovative technology to the public as rapidly as …
Accelerating Medical Device Innovation with Regulatory …
- https://www.fda.gov/news-events/fda-voices/accelerating-medical-device-innovation-regulatory-science-tools
- Jeffrey E. Shuren, M.D, J.D. The FDA's Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device developers can use in …
Medical Devices - Balancing Regulation and Innovation
- https://www.researchgate.net/publication/221758651_Medical_Devices_-_Balancing_Regulation_and_Innovation
- Request PDF | On Jan 19, 2012, Ned Feder published Medical Devices - Balancing Regulation and Innovation | Find, read and cite all the research you need on …
Balancing Innovation And Safety – The US …
- https://medtech.pharmaintelligence.informa.com/MT143347/Balancing-Innovation-And-Safety--The-US-and-Australian-Medtech-Regulatory-Systems-Compared
- The TGA has sought to improve the efficiency of its advisory committees, following the recommendations of the Medicines and Medical Devices Regulation Review …
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