|CDRH Industry Basics Workshop|
|The 510(k) Program|
|de novo Program|
|Corrective and Preventive Action Basics|
|Electronic Medical Device Reporting (eMDR) Basics|
Webinar: CDRH Industry Basics Workshop
Summary: This workshop (presented by webinar) provided information on the fundamental concepts of medical device regulations.
The workshop featured five sessions, each of which consisted of a presentation followed by a question and answer (Q&A) session with a panel of experts. Participants were able to email or call us with questions during each session.
Participants could choose to participate in any and/or all of the sessions. Each session began precisely at the scheduled time.
- 10:00-11:00 am: Investigational Device Exemption (IDE) Program
- 11:00-12:00 noon: 510(k) Program
- 12:00-1:00 pm: de novo
- 2:00-3:00 pm: Corrective and Preventive Actions (CAPA)
- 3:00-4:00 pm: Electronic Medical Device Reporting (eMDR)
Target Audience: Medical Device Industry, Medical Device Developers, Medical Device Industry Associations