DEVICES & IN VITRO DIAGNOSTICS (IVDs)
Investigational Device (IDE) Submissions
    ♦ Pre-IDE meetings
    ♦ Initial preparation and filing
    ♦ Maintenance during life of the IDE -– changes
Pre-Market Approval (PMAs) Applications and Pre-Market Notification
Submissions (510k’s)
                                                                                 
    ♦ Counseling on requirements
    ♦ MDUFMA and Application Fees
    ♦ Strategies to maximize approval process
    ♦ Responding to FDA deficiency letters
    ♦ Achieving binding agreements with FDA on clinical design
    Reclassification Petitions – easing the regulatory burden
               • “De Novo” petitions for truly “new” technologies
  • Traditional for pre-’76 devices
FDA Liaison & Meetings
    ♦ Pre-IDE Meetings
    ♦ End-of-Phase meetings (II, III)
    ♦ Advisory Panel preparation and meetings
Promotion and Advertising During R&D
    ♦ Reviews
    ♦ Training
Emerging FDA Issues & Their Impact on Development Plans
    ♦ Comment preparation on FDA initiatives
    ♦ Legislative responses
    ♦ Client-generated strategic initiatives
Medical Device Reporting ("MDRs")
    ♦ Regulatory classification of event
    ♦ Implementing
    • SOPs
    • Filings
    ♦ Managing Related Products Liability Risks
U.S. Agent Services
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FDA Legal Services --  for the life of a Life Sciences company
© 2014   Michael A. Swit.  
ALL RIGHTS RESERVED.

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Contact me @ 760-815-4762
or
mswit@fdacounsel.com
Michael A. Swit
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