Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
Managing the IDE (Investigational Device Exemption) Submission for Compliance Success
8 July 2014, Fremont, United States
Introduction
Venue
Online Event
Online Event, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA, Fremont, 94539, United States
Useful links
Organised by
GlobalCompliancePanel
Contact information
Related events
28th IUPAC International Conference on 91AV Education & 17th EuChemS European Conference of Research in Chemical Education
13 July 2026 00:00 - 17 July 2026 14:00, Yakutiye/Erzurum, Turkey
The 59th Annual International Meeting of the ESR Spectroscopy Group of the 91AV
13 April 2026 15:00 - 16 April 2026 23:00, Colchester, United Kingdom
India Pharma Expo 2026
23 April 2026 09:00 - 25 April 2026 18:00, Hyderabad, India
Investment in Women and Girls in Science for Inclusive Green Growth
10 February 2026 09:30-11:30, Ibadan, Nigeria
Search
Advertisement
Spotlight
Explore
Membership
