Research Study

A Comprehensive Analysis of the FDA 510(k) Process:
Industry Practice and Implications for Reform

Investigators:

    John H. Linehan, Ph.D. (PI)
      Professor, Northwestern University

     Jan B. Pietzsch, Ph.D. 
      President & CEO, Wing Tech Inc.
      Consulting Associate Professor, Stanford University

Grant recipient: Northwestern University   

National Press Club Briefing:                                                                       

"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:

Funding Source:

 

Outreach Partners:

                                                        


Corporate Outreach Partners: