FDACounsel.com  -- Legal Services -- for the life of a Life Sciences company

DEVICES & IN VITRO DIAGNOSTICS (IVDs) SERVICES

Investigational Device (IDE) Submissions
    ♦ Pre-IDE meetings
         • preparation
         • submissions
    ♦ IDEs
         • initial filing
         • maintenance during life of the IND – changes
    ♦ Reclassification Petitions – easing the regulatory burden
         • “De Novo” petitions for truly “new” technologies
         • Traditional for pre-’76 devices
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
    ♦ End-of-Phase meetings (I, II, III)
    ♦ Advisory Committee 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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© 2004 Law Offices of Michael A. Swit.  
ALL RIGHTS RESERVED.

Questions?

Contact us @ 760-815-4762
or
mswit@fdacounsel.com