Medical device standards seem to change and evolve all the time. Is it impossible to keep up with them? Do you know the latest and greatest when it comes to IEC 60601? FDA’s CDRH standards program? Consensus standards database? FDA’s ASCA pilot program?

On today’s episode, we have Scott Colburn of the FDA and Leo Eisner of Eisner Safety Consultants to discuss what’s currently happening in the medical device industry when it comes to standards.

SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:

● New versions of IEC 60601 are in the works; every five years, standards are reviewed to address collaterals, issues, and recommendations.

● Policy updates have been made regarding the appropriate use and recognition of voluntary consensus standards.

● FDA values such standards because of consistency, predictability, and credibility of science-based decisions around patient safety.

● FDA trains staff on standards and provides the medical industry with information on how to use FDA’s programs - working together to improve use of standards.

● Guidance is updated to be more efficient, consistent, and nimble: Process of recognizing and withdrawing standards.

● Describing the changes made regarding declaration of conformity vs. general use of standard.

● Some changes to standards are significant and affect requirements, such as updating normative references.

● Declaration of Conformity is a legal statement that shows you followed a specific path and applied a standard in accordance with its intent.