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.
What You Need to Know? 👇
What is the purpose of the Day-100 meeting in PMA applications?
The Day-100 meeting is required by FDA to discuss the review status of PMA applications. FDA must meet with applicants within 100 days of filing to review identified deficiencies and required information for correction.
When should I submit a request for a Day-100 meeting?
Submit your meeting request with the PMA or as an amendment no later than 70 days from FDA receipt of the filed PMA. This 30-day lead time allows FDA sufficient time to schedule the meeting.
What deficiency information will FDA provide before the Day-100 meeting?
FDA will provide written description of identified deficiencies approximately 90 days from filing, based on interim review of the entire application. This letter will be faxed at least 10 days before the meeting.
Who typically attends Day-100 meetings from FDA’s side?
The core review team, Branch Chief, Division Director or Deputy Director attend the meeting. Program Operations Staff and Office management may also participate as appropriate for the specific application review.
How often will FDA communicate after the Day-100 meeting?
FDA will continue communicating at least every 4 weeks via teleconference, fax, videoconference, or writing about review status and any additional required information until review completion and final action.
What topics are typically discussed during Day-100 meetings?
Meetings cover identified issues and remedial actions, action plans with completion dates, FDA review timetables, potential panel involvement needs, and possible premarket versus postmarket requirements for the application.
What You Need to Do 👇
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.