Presentation
Navigating the FDA Human Factors Validation Protocol Pre-Review and Pre-Sub Process
SessionValidation/Testing (MDD8)
DescriptionHaving the U.S. FDA review a Human Factors Validation Protocol or Human Factors Strategy through a pre-submission is almost always recommended for high-risk and home use medical devices. If a project’s timeline allows, gathering input from the agency on key human factors deliverables, including the Human Factors Validation Study Protocol, can be valuable.
Pre-submissions are voluntary and have no associated fees to encourage manufacturers to correspond with the FDA. Pre-submissions can help streamline design, development, and testing. Without a pre-submission, there is an increased chance of FDA feedback that could lead to substantial delays in the approval/clearance process as the manufacturer gathers additional data.
A Pre-submission begins with a formal written request by a device manufacturer, or their representative, for feedback from the FDA. Next, if requested, the FDA responds with non-binding written feedback. Then, if requested, a meeting between the FDA reviewers and the manufacturer is scheduled to discuss additional feedback or clarifications, documented and agreed upon in meeting minutes (1).
In this presentation we will:
1) present different situations related to human factors where a Pre-Submission can be valuable
2) walk through the high-level process of submitting a Pre-Submission request to the FDA and how best to prepare the request
3) present general logistics for Pre-Sub meetings as well as how to best prepare for and manage the meetings with the FDA
Throughout the presentation we will summarize key requirements from the following FDA Guidance document:
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff ( June 2, 2023)
We will also present the difference for gathering feedback from DMEPA in various meeting types versus gathering feedback from CDRH as part of the Q-sub or Breakthrough Devices programs.
Pre-submissions are voluntary and have no associated fees to encourage manufacturers to correspond with the FDA. Pre-submissions can help streamline design, development, and testing. Without a pre-submission, there is an increased chance of FDA feedback that could lead to substantial delays in the approval/clearance process as the manufacturer gathers additional data.
A Pre-submission begins with a formal written request by a device manufacturer, or their representative, for feedback from the FDA. Next, if requested, the FDA responds with non-binding written feedback. Then, if requested, a meeting between the FDA reviewers and the manufacturer is scheduled to discuss additional feedback or clarifications, documented and agreed upon in meeting minutes (1).
In this presentation we will:
1) present different situations related to human factors where a Pre-Submission can be valuable
2) walk through the high-level process of submitting a Pre-Submission request to the FDA and how best to prepare the request
3) present general logistics for Pre-Sub meetings as well as how to best prepare for and manage the meetings with the FDA
Throughout the presentation we will summarize key requirements from the following FDA Guidance document:
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff ( June 2, 2023)
We will also present the difference for gathering feedback from DMEPA in various meeting types versus gathering feedback from CDRH as part of the Q-sub or Breakthrough Devices programs.
Event Type
Oral Presentations
TimeWednesday, March 278:30am - 8:52am CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices