In recent years, FDA has released numerous draft guidances to streamline the review process, elevate the level of scrutiny placed on submissions and ensure the safety and efficacy of devices. With a steady influx of communication from FDA to the device industry, CEOs and regulatory teams struggle to keep up, understand and implement procedures that adhere to developing FDA guidelines. Some guidances exceed the agency's authority and is often inconsistent with the statute and existing regulations. This session will provide examples where it is acceptable and often necessary to diplomatically push back on the agency. Recent examples of push back include, Congress requiring FDA to withdraw its 510(k) Modifications guidance and a Citizen Petition filed by the Minnesota Medical Device Alliance (written by Mark DuVal) which requests that FDA stay the implementation of its newly proposed guidance and revert to existing 510(k) guidance documents.
Navigating the Changing Regulatory Landscape by Forecasting Effects of New FDA Guidances
- On January 30, 2014 at 09:01AM
- Categorized in Conferences