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Investigational Device (IDE) Submissions
♦ Pre-IDE (pre-submission) 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” requests for truly “new” technologies
• Traditional for pre-’76 devices
FDA Liaison & Meetings
♦ Pre-Submission Meetings
♦ End-of-Phase meetings (II, III)
♦ Advisory Panel preparation and meetings
Combination Products (Device/Drug or Device/Biologic)
♦ Counseling on key issues
• Determining Primary Mode of Action (PMOA)
• GMP guidance
• Handling Post-market Surveillance duties
♦ Requests for Designation (RFD)
♦ Meetings with Office of Combination Products (OCP)
♦ Comment preparation on FDA initiatives
Medical Device Reporting ("MDRs")
♦ Regulatory classification of event
♦ Implementing
• SOPs
• Filings
♦ Managing Related Products Liability Risks
Digital Health & Mobile Medical Apps
♦ Assessing apps vs. FDA Mobile Medical Apps Guidance