DEVICES & IN VITRO DIAGNOSTICS (IVDs)

♦ Strategic Regulatory Plans -- understanding the road to market
♦ Reclassification Petitions – easing the regulatory burden
     • “De Novo” petitions for truly “new” technologies
      • Traditional for pre-’76 devices
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
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
For presentations and articles on Medical Devices & IVDs, just click here ...
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© 2012   Michael A. Swit.  
ALL RIGHTS RESERVED.

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or
mswit@fdacounsel.com