510(k) Success: Crafting Persuasive Substantial Equivalence Arguments

1 Hour Video | James Flaherty, Jr., Fresenius Medical Care North America

The 510(k) premarket notification pathway continues to evolve, with the FDA releasing a variety of guidance documents and recommendations in recent years. With so many new developments and proposals, regulatory professionals must stay educated and adapt in order to convincingly demonstrate substantial equivalence for a successful 510(k) review. As requirements continue to evolve, device manufacturers are revising and refining approaches for persuasively demonstrating substantial equivalence to stay current and compliant.  This session will:

  • Provide updates on FDA 510(k) requirements, guidance, and initiatives
  • Pinpoint risk factors utilized by FDA when determining substantial equivalence
  • Address areas of ambiguity and strategize how to use these to your advantage
  • Identify tactics for successfully working with FDA


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

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 James M. Flaherty, Jr.
Associate General Counsel – FDA Regulatory
Fresenius Medical Care North America

James M. Flaherty, Jr. (Jim) is Associate General Counsel – FDA Regulatory at Fresenius Medical Care North America (FMCNA), a vertically-integrated renal care company headquartered in Waltham, Massachusetts. Jim’s primary role is working with the medical device and pharmaceutical groups of FMCNA on FDA strategy and tactics regarding premarket submissions and postmarket compliance.  He also advises all divisions of FMCNA on FDA-related issues, including interactions among divisions that implicate FDA regulations. Prior to joining FMCNA, Jim was with the law firm Foley Hoag LLP in Boston for eleven years, where he advised medical device, pharmaceutical, and biotechnology companies on federal legislative and regulatory issues relating to FDA law and regulation.  His practice at Foley Hoag also involved representing clients in biomedical intellectual property disputes, particularly those involving FDA issues.  Before Foley Hoag, Jim spent five years with Johnson & Johnson, most recently as Regulatory Affairs Manager at the Codman neurosurgical division.

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