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FDA Priorities: Pre- and Post-Market Data Requirements and PMAs

● Product Management ● Regulatory/Clinical Affairs

This session will address recent FDA regulatory developments with a focus on CDRH's 2014-2015 priorities and implications for orthopaedic device manufacturers. Emphasis will be placed on efforts to speed products to market through a rebalancing of pre- and post-market data requirements, as well as CDRH's efforts to help companies accelerate the PMA approval process for particular technologies. Mr. Gaba will also address how to communicate effectively with the FDA and the implications of the agency's globalization efforts.

Session Takeaways:
• CDRH's Strategic Priorities for 2014-2015 and its efforts to promote public health
• Understanding of two recently released Draft Guidance documents: Data Requirements to Support a PMA
  and Expedited PMA Process
• Grasp of CDRH’s efforts to revise its regulatory framework to become a leader in the ever-contracting global marketplace
• Knowledge to make more informed business decisions as a result of having a greater gasp on CDRH’s
  renewed mission.

Gaba Michael_WEBMichael M. Gaba
Holland & Knight

Michael M. Gaba is a partner in the Washington, D.C. office of Holland & Knight where he is the Federal policy leader of the firm’s national Healthcare & Life Sciences Team. His regulatory and legislative life sciences practice includes counseling and representing medical device and biotech companies before FDA, CMS and the U.S. Congress. Mr. Gaba advises clients on get-to-market strategies, including handling the implications of pursuing de novo or 510(k) pathways, labeling and promotional claims, clinical study design and quality system regulation compliance. He also counsels clients on post-market surveillance issues, including instituting product recalls, responding to 483s and Warning Letters, and challenging adverse agency decisions for Class III high risk products. With an eye toward helping clients get to market and stay there, Mr. Gaba also counsels medical device and biotech companies on coverage, coding and reimbursement strategies before CMS to enhance patient access to innovative technologies. Mr. Gaba serves on the Advisory Board of Bloomberg BNA's Medical Devices Law & Industry Report and served on the Editorial Advisory Board of the Food and Drug Law Institute's Food and Drug Law Journal. He is consistently recognized as a leading lawyer in the life sciences regulatory field by Chambers USA and Best Lawyers in America.