REGULATORY
Prepare to meet thy regulator MANUFACTURERS STAND TO GAIN TIME AND COST BENEFITS IF THEY CAN FACILITATE A SUCCESSFUL PRE-SUBMISSION MEETING WITH THE FDA PRIOR TO MAKING THEIR FINAL MEDICAL DEVICE APPLICATION SUBMISSION. SANDI SCHAIBLE, SENIOR DIRECTOR OF ANALYTICAL CHEMISTRY AND REGULATORY TOXICOLOGY, WUXI APPTEC, AND MICHELLE LOTT, FOUNDER AND PRINCIPAL OF LEAN RAQA, ADVISE HOW TO SQUEEZE THE MOST OUT OF THESE ONE-TIME-ONLY MEETINGS.
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he more a manufacturer can collaborate with regulators, the better the manufacturer can identify submission expectations and potential challenges. An effective way to do so is through a successful pre-submission meeting with the US Food and Drug Administration (FDA). These meetings allow manufacturers to work with the FDA to review their medical device testing plans and address concerns before final submission. Facilitating a pre-submission meeting with a regulatory reviewer is a critical resource for a manufacturer trying to get a device cleared with the FDA. Currently, there is no similar pre-submission
pathway available in the European Union (EU) as notified bodies (NBs) are not available for consultive purposes. Competent Authorities are inconsistently interpreting and applying the EU Medical Device Regulation (MDR), creating a wide difference in what each NB will accept. An effective pre-submission meeting can reduce time and money spent preparing the submission and increases the chance of gaining approval. There are three forms of feedback manufacturers can request from the FDA: written responses only; a 60-minute teleconference; or an in-person meeting. In light of the pandemic, meetings are held in a digital format via video or teleconferencing. No matter what they choose, manufacturers must come prepared to make the most of their time. Understanding how to best leverage a pre-submission meeting can set companies and their device up for successful regulatory submission. GETTING STARTED Manufacturers must have a detailed understanding of their device before initiating a pre-submission meeting. This includes knowing the intended use, features, functions, testing strategy, along with how it compares to a predicate. In addition, it is critical to develop clarifying questions on FDA’s initial response to send to the FDA before the meeting. These questions should be sorted by priority and consider regulatory updates and other highrisk topics that need addressing before final submission. Once the FDA responds to the questions, this feedback will guide the specific talking points for the meeting. WHAT TO EXPECT The reviewers will only come prepared to discuss their responses to the questions submitted by the manufacturer ahead of the meeting. Anything outside the preliminary topics should not be addressed during the pre-submission meeting. The pre-submission process allows manufacturers to work with the FDA directly to gain their insight. Based on the responses provided before the meeting, manufacturers can follow up and pinpoint specific areas of their plan where they would like greater detail about the reviewers’ feedback. Prioritize potential talking points to improve the testing plan and minimize additional information requests. Keep in mind that this meeting is not the time to negotiate or barter. Even if the feedback is unexpected or not ideal, essential factors such as patient safety and submission approval may be at stake if manufacturers don’t take
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