510(k) Preparation with New Released FDA Guidance on Product Modifications 2016 is a webinar that covers topics such as:
- What is Refuse To Accept policy?
- Unique terminologies in 510(k)
- Selecting a predicate device (substantial equivalence)
- What is a predicate device?
- How to handle software?
- Where to find substantially equivalent predicate devices?
- 510(k) procedure for device modifications
510(k) Preparation with New Released FDA Guidance on Product Modifications 2016 is intended for attendees from:
- QA
- Engineering personnel
- Management
- Software developers