In response to The Medical Device User Fee Amendments of 2012 (MDUFA III),which authorizes FDA to collect user fees for the review of certain premarket submissions, FDA proposed process improvements to provide further transparency to the review process and to update the Agency’s approach to the Interactive Review to reflect FDA’s commitments in the MDUFA III Commitment Letter. The updates are described in the draft guidance released on March 5, 2013 titled Types of Communication During the Medical Device Submissions.
Purpose of the Interactive Review: To facilitate the efficient and timely review by increasing interactions between the applicant and FDA to exchange scientific and regulatory information and address deficiencies that are minor without placing the submission on hold.
The goal of the review is to:
- Improve interaction
- Decrease unnecessary delays and reduce overall time to market
- Ensure clear communication of the FDA’s concerns noted during the review process
- Minimize the number of review cycles
- Minimize the number of review questions conveyed through deficiency letters
- Ensure timely responses from applicants
FDA as found that the Interactive Review can be used for more than just “minor” deficiencies, rather, the review can be expanded to address deficiencies that are more significant than minor without putting the submission on hold.
The guidance provides the following examples:
- Requests for limited additional short-term laboratory bench or biocompatibility testing
- Further justification for the omission of a test
- Additional statistical analysis of the clinical data not related to the primary safety or efficacy endpoint
Interactive Review after a Substantive Review:
After a Substantive Review, the applicant must submit a complete response to FDA so that the FDA may resolve any remaining deficiencies reasonably addressed through Interactive Review. New deficiencies should be limited to issues raised in the information provided in response to the Substantive Review. FDA will send a communication listing the remaining issues near the end of the review cycle with the goal of a timely MDUFA decision by allowing for a maximum of 7 calendar days for the applicant to respond.
If the deficiencies can not be resolved through Interactive Review, FDA may proceed by issuing a Not Substantially Equivalent (NSE) letter for a 510(k) or a Not Approvable (NOAP) letter for a PMA.
Additional Interactive Review:
To facilitate the efficient and timely review, at FDA’s discretion, the use of Interactive Review maybe encouraged at other points of the review process.
- Prior to Substantive Interaction for 510(k), Original PMAs, Panel-Track PMA Supplements, and 180-Day PMA Supplements
- As needed for BLAs, BLA supplements, Humanitarian Device Exceptions, (HDEs) and Product Development Protocols (PDPs).
Email and fax is FDA’s preferred communication tool for Interactive Review while phone calls should be primarily used for clarification. Face-to-face meetings, teleconferences and videoconferences require additional planning and administrative efforts and therefore are only considered if a meeting is the most appropriate and effective mechanism to resolve issues. FDA is ultimately responsible for ensuring a complete administrative file for each submission.
The guidance suggests that the applicant do the following to ensure the Interactive Review process is effective:
- Submissions should be well-organized as well as administratively and scientifically complete and consistent with the regulations, guidance documents and prior communications with FDA
- Provide complete and alternative contact information in the cover letter
- Attach material or testing standards to support the use of the standards
- Provide a complete response to all deficiencies within the FDA-allotted timeframe
Now that FDA has decided that more significant than just “minor” deficiencies can be addressed and resolved by Interactive Review, will the timeline to approval decrease? What do you think the overall benefit, if any, will be by broadening the types of deficiencies that can be reviewed? Does the guidance provide clear suggestions for the applicant in preparing an effective submission?
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