Strategies for the 510(k) pathway: Submission and Approval
- -Determining whether a device qualifies for 510(k) and exploring strategies around establishing "substantial equivalence"
- -Utilizing other factors such as conformance to voluntary standards to demonstrate SE
- -Establishing criteria for selecting a master device and grandfathering
- -Understanding device-to-part vs. device-to-device comparison and regulatory nuances around the comparison
- -Addressing "new questions of safety and efficacy" and "different technological characteristics"
- -Discussing items to include in a 510(k) application and preparing a summary/statement
- -A case study on 510(k) submission