Post

Day-100 Meetings for PMA Applications: Procedures and Implementation

This guidance outlines the procedures for implementing interactive review provisions for PMA (Premarket Approval) applications, specifically focusing on Day-100 meetings between FDA and applicants. It applies to original PMA applications received by FDA on or after February 19, 1998.

  1. Establish internal process for submitting Day-100 meeting requests within 70 days of PMA filing
  2. Create template for meeting requests including attendee list and preferred meeting dates
  3. Designate internal point of contact to coordinate with FDA project manager
  4. Develop procedure for quick response to FDA deficiency communications
  5. Establish internal documentation system for all FDA interactions
  6. Create follow-up schedule to maintain 4-week communication cycle with FDA
  7. Implement process for reviewing and responding to meeting minutes
  8. Set up capabilities for various meeting formats (teleconference, videoconference, face-to-face)

Key Considerations

Other considerations

No specific norms or standards are referenced in this guidance.


Original guidance

  • Day-100 Meetings for PMA Applications: Procedures and Implementation
  • HTML / PDF
  • Issue date: 1998-02-18
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Administrative / Procedural, Premarket, Premarket Approval (PMA)
  • ReguVirta summary file ID: 1c432ead3fd9c1bde0d74be494014e5e
This post is licensed under CC BY 4.0 by the author.