510(k) Cititical Decision Points in New FDA Guidance

FDA has issued a draft guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510( k)], to identify, explain, and clarify each of the critical decision points in FDA decision-making process used to determine substantial equivalence. The guidance is not implementing significant policy changes in the 510(k) review process, FDA says, but rather is intended to enhance the predictability, consistency, and transparency of the 510(k) program by describing in detail the regulatory framework, policies, and practices underlying agency 510(k) review. It also updates agency policies for the Special 510(k) program.

Topics covered include the 510(k) decision-making process and alternative approaches to the traditional 510(k) submission. There are appendices on a proposed 510(k) decision-making flowchart, the 510(k) summary document requirements, the 510(k) process, contents of a Special 510(k) submission, sample risk analysis summary, and abbreviated 510(k) content.