Types of Communication During Medical Device Submissions Review
This guidance describes four types of communication that occur during the review of medical device submissions: - Acceptance Review Communication for 510(k)s, Original PMAs, Panel-Track PMA Supplements, and Pre-Submissions - Substantive Interaction for 510(k)s, Original PMAs, Panel-Track PMA Supplements, and 180-Day PMA Supplements - Interactive Review - Missed MDUFA Decision Communication for 510(k)s, Original PMAs, and Panel-Track PMA Supplements
Recommended Actions
- Ensure submission is complete and well-organized before initial filing
- Include complete contact information in cover letter including alternative contacts
- Monitor and meet FDA-specified timeframes for responding to Interactive Review requests
- Use email/fax as primary communication tools during Interactive Review
- Document all communications during Interactive Review process
- Contact FDA lead reviewer/RPM promptly for any clarifications or issues during review
- Establish secure email communications with FDA if desired
- Have US representative available for foreign companies
- Be prepared to participate in meetings/teleconferences if needed for Missed MDUFA Decision Communication
- Consider using Pre-Submission Program to obtain FDA feedback before formal submission
Key Considerations
Other considerations
- Acceptance Review Communication should occur within 15 days of receipt for 510(k)s, Original PMAs, Panel-Track PMA Supplements and within 14 days for Pre-Submissions
- Substantive Interaction should occur within:
- 60 days for 510(k)s
- 90 days for Original PMAs and Panel-Track PMA Supplements
- 90 days for 180-Day PMA Supplements
- Interactive Review can be used for both minor and more significant deficiencies that could be addressed within MDUFA timeframes
- Email and fax are preferred communication tools for Interactive Review
- Responses to Interactive Review requests should be provided within FDA-specified timeframes
- For Missed MDUFA Decision Communication, FDA should provide written feedback including outstanding issues, action items, estimated completion dates, and proposed meeting dates
Relevant Guidances
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- MDUFA Performance Goals and Processing of 510k Submissions
- FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Related references and norms
NO_SPECIFIC_REFERENCES_TO_NORMS
Original guidance
This post is licensed under CC BY 4.0 by the author.