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.
Recommended Actions
- Establish internal process for submitting Day-100 meeting requests within 70 days of PMA filing
- Create template for meeting requests including attendee list and preferred meeting dates
- Designate internal point of contact to coordinate with FDA project manager
- Develop procedure for quick response to FDA deficiency communications
- Establish internal documentation system for all FDA interactions
- Create follow-up schedule to maintain 4-week communication cycle with FDA
- Implement process for reviewing and responding to meeting minutes
- Set up capabilities for various meeting formats (teleconference, videoconference, face-to-face)
Key Considerations
Other considerations
- Meeting request must be submitted within 70 days from FDA receipt of the filed PMA
- FDA will provide written description of deficiencies by day 90 or 10 days before the meeting
- Core review team, Branch Chief, and Division Director must attend the meeting
- Continued communication every 4 weeks after Day-100 meeting until review completion
- All interactions must be documented in the administrative record
- Meeting can be face-to-face, teleconference, or videoconference
Relevant Guidances
- FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Modular Submissions for Premarket Approval Applications and Humanitarian Device Exemptions
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
Related references and norms
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
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