Home - 510k.net - A Comprehensive Analysis of the FDA 510(k) Process - Research Study - Linehan, Pietzsch
Description
pulled from site's meta descriptionThis site reports on the findings of the research study "A Comprehensive Analysis of the FDA 510(k) process - Industry Practice and Implications for Reform." Investigators: John Linehan, Jan Pietzsch
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- AboutUs AutoGen
- 510k
- FDA
- Northwestern University
- Wing Tech Inc.
- Stanford University
- InHealth
- Regulatory Process
- CDRH
- Food & Drug Administration
- Center for Diseases and Radiological Health
- John Linehan
- Jan Pietzsch
- regulation of medical devices
- regulatory
- food and drug administration
- five ten k
- 510(k)
- 510K
- 510-k
- PMA
- pre market approval
- regulatory path
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- US Regulatory System