Services -- Medical Devices, IVDs, & Digital Health

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