1 Hour and 30 Minute Video | Mahnu Davar and Philip R. Desjardins, Arnold and Porter LLP
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?
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Legal Counsel
- Compliance Officers
This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
Mahnu Davar is an associate in Arnold & Porter’s FDA/Healthcare practice in Washington, DC. Mr. Davar has extensive experience counseling medical device companies on a host of complex legal issues including compliance with the federal Food, Drug, and Cosmetic Act, state and federal anti-kickback laws, anti-bribery/corruption laws, and transparency laws. Mr. Davar is a return speaker to Q1.
Philip R. Desjardins
Arnold and Porter LLP
Philip Desjardins is a Counsel in the firm's Washington, DC office. He represents medical device, diagnostic, pharmaceutical and other FDA-regulated companies in regulatory and policy matters.
Prior to joining private practice, Mr. Desjardins was an attorney with the U.S. Food and Drug Administration (FDA) and served as Regulatory Counsel at the Agency's Center for Devices and Radiological Health (CDRH) and Acting Regulatory Counsel in the Center for Tobacco Products.