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
What You Need to Know? 👇
What are the four types of communication during FDA medical device submission reviews?
The four types are: Acceptance Review Communication (for 510(k)s, PMAs, Panel-Track PMA Supplements, and Pre-Submissions), Substantive Interaction, Interactive Review, and Missed MDUFA Decision Communication for submissions that don’t meet performance goals.
When does FDA provide Acceptance Review Communication for medical device submissions?
FDA provides Acceptance Review Communication within 15 days of receipt for 510(k)s, Original PMAs, or Panel-Track PMA Supplements, and within 14 days for Pre-Submissions. This confirms acceptance or identifies missing items.
What is the purpose of Substantive Interaction in medical device reviews?
Substantive Interaction either notifies applicants that FDA will continue working through Interactive Review without placing the submission on hold, or places the submission on hold while identifying deficiencies that must be addressed.
How does Interactive Review differ from traditional FDA communication methods?
Interactive Review uses informal communication tools like email, fax, and phone calls to address deficiencies efficiently without stopping the review clock. It’s designed to prevent delays and minimize review cycles through increased interaction.
What types of deficiencies can be addressed through Interactive Review?
Interactive Review can address minor deficiencies and more significant issues that can be resolved within MDUFA timeframes, such as limited additional testing, justification for omitted tests, or additional statistical analysis not related to primary endpoints.
When does FDA issue a Missed MDUFA Decision Communication?
FDA issues this communication when submissions haven’t reached a MDUFA decision by 100 FDA days for 510(k)s or 20 FDA days after the applicable goal for Original PMAs and Panel-Track PMA Supplements.
What You Need to Do 👇
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 🔗
- Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
- 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 📂
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