This guidance was released on July 28, 2014. FDA developed this document to provide guidance about current review practices for premarket notifications (510(k)) submissions. FDA’s intent is to identify, explain and clarify each of the critical decision points in the decision making process FDA uses to determine substantial equivalence. The intent of this document is to enhance the predictability, consistency and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies and practices underlying FDA’s 510(k) review process.
This webinar is a must for those personnel that require an understanding of the FDA’s 510(k) substantial equivalence determinations.
Areas to be Covered:
510(k) Regulatory Framework
510(k) Critical Decision Points for Substantial Equivalence
Who will Benefit:
Regulatory Affairs Personnel
Clinical Research Associates
Personnel who require a general understanding of the FDA’s 510(k) program for determining substantial equivalence