Streamlining Clearance & Approval Processes by Thoroughly Understanding Implications of New FDA Guidances Surrounding 510(K) Device Modifications & Refuse-to-Accept Policy while Successfully Addressing Inconsistency in Reviewer Feedback
The medical device regulatory landscape continues to evolve as new guidances are released by FDA, & global regulatory bodies are emerging or developing stricter guidelines for product approvals. Regulatory affairs executives in the device industry must stay abreast of these changing regulations in order to implement forward-thinking strategies for streamlining product approvals, & ultimately bring new & innovative products to market that will advance healthcare outcomes. The 3rd Annual Medical Device Regulatory Clearance & Approval Conference will build off the success from previous meetings by bringing together perspectives & insights from leading regulatory affairs professionals & innovative device manufacturers on how to ensure positive regulatory clearance & approval decisions in the US & internationally.
This two day conference will take place in Alexandria, Virginia on October 28-29, 2013. Attendees of this year’s program will have an exclusive opportunity to gather the latest insights into new & evolving FDA guidances & the implications for device manufacturers. Two key guidances of concern for regulatory affairs executives include the re-release of the 510(K) Device Modifications guidance along with the recent Refuse-to-Accept Policy. Presentations will also address internal strategies for tackling inconsistencies amongst FDA reviewer feedback & an increase in data requirements Continue reading