DEVELOPING AN EFFECTIVE 510 (K) APPLICATION STRATEGY IN A RESOURCE CONSTRAINED ENVIRONMENT

Innovative medical product companies are under constant pressure to do more with less. In this environment, even the 510(k) clearance process can seem onerous and resource intensive, particularly for companies unfamiliar with FDA requirements or for those who have devices that cannot be easily classified. As CDRH continues to evolve its regulatory framework and manage its own resource constraints, regulated industry must continue to have a clear understanding of regulatory submission and clearance requirements. In an effort to manage its resources, CDRH has created a system which seeks to reward companies that engage with the Agency early and effectively and discourages incomplete or inadequate filings. This webcast will survey critical considerations for successful engagement with FDA during the 510(K) submission process and identify some areas of current FDA focus that may help save manufacturers time and financial resources in getting their products approved:

• Benefits to engagement through the Pre-De Novo Submission Process
• Submission timelines and requirements
• FDA’s “Refuse to Accept” Policy
• Forward-looking discussion: where is CDRH heading?

Speaker:
Mahnu Davar
Associate
Arnold and Porter LLP