The current regulatory environment has created opportunities and setbacks for medical device companies as they work toward obtaining regulatory approval on their products. On the one hand, the delayed EU Medical Device Regulation (MDR) deadline means manufacturers have more time to prepare their applications for the European market. On the other, the industry at large is still responding to a global pandemic, which has strained capacity and led to supply chain disruptions that can affect development timelines.
To streamline the submission and approval processes for devices bound for the U.S. market, regulators from the U.S. Food and Drug Administration (FDA) encourage manufacturers to take a more active and collaborative approach to their submissions. Part of this effort includes scheduling a pre-submission meeting with regulators to discuss the device, review testing strategies and connect with the experts on your team. Doing so can help save time and money long-term by garnering regulator’s invaluable insight on the road to a successful submission—at least in the U.S.
Currently, there is no pre-submission pathway available for medical devices meant for the European market. Notified bodies (NBs) review and progress potentially new devices, but they’re unavailable prior to submission because they cannot act as consultative. In addition, while European researchers await updates to MDR, authorities are applying outdated standards inconsistently. Unfortunately, a successful strategy with one product submission may not work with another.
You can make the most out of pre-submission meetings with the U.S. FDA by preparing a clear strategy and recognizing gaps in your product, the planned evaluation and the team you plan to bring to the meeting. Regulators have a keen sense for similar products in the market and will be investigating what makes your product unique.
Basic Preparation
Scheduling a pre-submission meeting is relatively straightforward. The U.S FDA will usually assign you a timeslot within a month of your request. However, you are only allowed one meeting per device application and it only lasts an hour, so you want to make sure you and your team are ready to make the most of it.
As you prepare for your meeting with the U.S. FDA, it is important to consider a few key points. The American regulatory body generally emphasizes an experience-based methodology when categorizing risk and device classification. If a predicate device does not exist, the U.S. FDA might decide it has a higher risk classification. A higher risk classification could mean special labeling requirements, performance standards and post-market surveillance. A device deemed a significant risk (SR) or one for which no predicate device exists may require additional steps, including procuring an Investigational Device Exemption (IDE) before beginning your study. At the end of the day, the U.S. FDA will expect you to be prepared for how your device may be classified.
Ahead of your meeting, familiarize yourself with every aspect of your device, or make sure someone with the proper background knowledge is a part of the meeting. Fully understand its constituent materials and their testing history, along with your development process, and the category and classification of your device. Part of your preparation should be to anticipate the questions you think the investigators will ask. They will review your testing plans, so make sure they are up to date and as comprehensive as possible. The better prepared you are, the more successful the meeting will be.
Partnering Up
Including your testing partner during the preparation phase can be invaluable. They can be especially helpful when outlining your formal testing strategy: identifying the risk associated with the device, how to meet the identified risks, and specific tests that will be performed i.e., chemical characterization, cytotoxicity and more. The regulatory bodies will want as much detail as possible and a testing partner can provide this essential documentation.
A testing partner can also be useful as your team’s go-to expert in the meetings themselves. Testing partners might even be better able to address specific questions or concerns during the meeting. Investigators place a high value on qualified personnel developing strategies–they often want to see the CVs of those who’ve written your strategy–and it is helpful to defer to testing partners and their expertise. Some regulators prefer that manufacturers bring their testing partners with them to these meetings. You should rely on your team and your testing partner to know their roles before the pre-submission meeting begins.
The Last Word
Planning ahead and including the essential members of your team can ensure you’re ready for a successful pre-submission meeting. Doing so will assist in the approval process and prepare you and your devices for successful outcomes.
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WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient, socially responsible and sustainable solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 4,400 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.”
