Equivalence Web-based Seminars

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...and Abbreviated submissions * Understand Substantial Equivalence and how it is applied * Who is required to submit the application to FDA * Where to submit the 510(k) and what to expect with the review and approval process * When it is and is not required if you are a device company * Exemptions to the submission process and special considerations * How to locate a  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ...ce process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and "Indications for Use" eliminated The FDA will likely increase the requirements for the Summary of Safety and Effectiveness and require a summary of all scientific information known or that should be reasonably known to the submitter regarding the safety and/ or effectiveness of the  more...