Research Study
A Comprehensive Analysis of the FDA 510(k) Process:Industry Practice and Implications for Reform
John H. Linehan, Ph.D. (PI)
Professor, Northwestern University
Jan B. Pietzsch, Ph.D.
President & CEO, Wing Tech Inc.
Consulting Associate Professor, Stanford University
"A Comprehensive Analysis of the FDA 510(k) Process" (Slide deck)
NPC Event (Main page through InHealth site)
Video pages (Part 1, Part 2, Part 3, Part 4)
Publications:
Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience (J. Med. Devices 6, 021015 (2012))
Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience - Part 2: Medical Device Ecosystem and Policy (accepted for publication, J. Med. Devices - forthcoming)
Other Study documents:
- Study initiation Read press release
- Study launch webcast
- InHealth 510(k) Webcasts
- January 10 panel event
Funding Source:
Outreach Partners:
Corporate Outreach Partners: