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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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