The FDA’s current views on communication during the review of medical device submissions can be found in the Types of Communication During the Review of Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff. This guidance proposes improvements for the review process, including four types of communication.
1. Acceptance Review Communication
Purpose: This type of communication is for premarket notification submissions (510(k)s), original premarket approval applications, Panel-Track PMA Supplements, and Pre-Submissions. The Acceptance Review Communication is used to” identify the lead reviewer or Regulatory Project Manager assigned to the submission and confirm acceptance of the submission or notify the submitter that the submission was not accepted based upon the review of the submission against objective acceptance criteria.” (FDA)
Time frame: The Acceptance Review Communication should occur within 15 days of receipt of a 510(k), Original PMAs, or a Panel-Track PMA Supplement and within 14 days of receipt of a Pre-Submission.
2. Substantive Interaction
Purpose: This type of communication is for 510(k)s, Original PMAs, Panel-Track PMA Supplements, and 180-Day PMA Supplements. The Substantive Interaction is either notification that the FDA will continue working with the applicant to resolve any issues through Interactive Review, or notification placing the submission on hold and identifying the issues which need to be addressed before substantive interaction can continue.
Time frame: “Substantive Interaction should occur following acceptance of the submission and after FDA has performed a complete review of the submission and within:
60 days of the receipt date of a complete submission for 510(k)s;
90 days of the filing date for Original PMAs and Panel-Track PMA Supplements
90 days of the receipt date for 180-Day PMA Supplements”
3. Interactive Review
Purpose: The Interactive Review process follows the Substantive Interaction. Interactive Review occurs when the submission is under review and has no impact on the review clock. The purpose of the Interactive Review is to create an efficient FDA review of premarket submissions using more interaction between the applicant and the FDA. The updated Interactive Review process should improve the communication between the applicant and the FDA and reduce delays in review and time to market. To help facilitate an effective Interactive Review the applicant should submit an organized and complete submission, give all contact information, use appropriate testing standards and submit necessary data to support the standard, and give a thorough and timely response to all deficiencies found during Interactive Review.
4. Missed MDUFA Decision Communication
Purpose: This type of communication is for 510(k)s, Original PMAs, and Panel-Track PMA. The purpose of this communication is to quickly resolve any issues that have kept the FDA from reaching a MDUFA decision prior to the goal time frame.
Time frame: “A Missed MDUFA Decision Communication should occur for those submissions that have not reached a MDUFA decision by:
100 FDA days for 510(k)s
20 FDA days after the applicable FDA day goal for Original PMAs and Panel-Track PMA Supplements.