1. Build your case, if regulators cannot or do not yet understand a technology, they will struggle to establish ways to assess the safety and effectiveness of your product.
· Find clinical and regulatory information throughout the world that is supportive of what you are trying to achieve. If negative information is uncovered, do not ignore it; instead, address it.
· Do not plan on submitting a “black box.” Spend the time to develop ways to communicate how and why a particular result comes about.
· Seek related credible sources, publications, guidance documents and experts, reference them, and utilize them.
2. Plan on early and frequent meetings with regulatory authorities. Gaining regulatory clearances for emerging technologies benefits from building solid working relationships with regulatory bodies. These relationships are built over a series of meetings that begin early in the development process, aiding both parties as they learn together. These early collaboration meetings provide a venue for industry to explore new ideas with regulators. Based on working with many novel products, we recommend the following considerations, particularly in working with the FDA.
· Start with a solid pre-submission package. Make certain to follow established guidelines for pre-submissions, setting the tone that your organization has done its homework. Additionally, a complete pre-submission package enables regulators to prepare for the meeting and identify the appropriate experts needed.
· Be ready for questions surrounding mechanism of action. In traditional medical devices, a key component of the submission surrounds the mechanism of action, or how the device is perceived to work. Be prepared to explain what your novel technology does and how it does it.
· Prepare for the meeting. Before the meeting or teleconference, identify your question areas and structure your questions to get the specific information needed without using open-ended formats. Avoid introducing new information that the FDA is not prepared to discuss.
· Set an open tone during the meeting. Be transparent about the information you have and the areas that are lacking. In early development cycles, gaps exist and it is important to be candid so you get accurate early feedback. Set aside any fears that your organization is setting precedent by not having complete information and instead, work to close those gaps as you progress through the product development process.
· Set specific but realistic expectations for meetings. Your device is novel and that means regulators have not seen anything like it before. Expect regulators will have questions that will be challenging to answer. Remember, agencies can only provide feedback on what you have presented--what your device is currently-- and not what you hope it will be in the future.
· At all times, be professional and seek to understand their questions. Early collaboration around emerging technologies is a two-way street. When you provide information the FDA needs, they will provide direction to guide your product development. And remember, the agency is a resource. Be open to the answers you receive, so your processes can evolve and improve.