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 Covered in the Session :510(k) Regulatory Framework510(k) Policies510(k) Practices510(k) Critical Decision Points for Substantial Equivalence Who Will Benefit:Regulatory Affairs PersonnelQuality PersonnelClinical PersonnelResearch PersonnelLaboratory PersonnelManufacturing PersonnelLegal PersonnelClinical Research AssociatesPersonnel who require a general understanding of the FDA's 510(k) program for determining substantial equivalencePrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299