The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology

How do you keep your investors at ease while communicating with the FDA?

June 20, 2022

One of the biggest hurdles for a medical device development company is the approval they must seek from the FDA to make claims that support their goal to aid in the resolution of the ailment the patient is suffering from. This process is lengthy and costly to the company and is critical for investors who are looking for opportunities to fund medical devices compared to consumer devices or wellness products (see what the differences are here). 

Each company will engage the FDA or any other regulatory body at various levels. Typically, a company will request a pre-sub meeting where there are various questions regarding the product category, testing and safety protocols that will be needed to prove safety and effectiveness of the product. This is a voluntary process where companies can gather information to make sure they don’t waste time or money working toward goals that the regulatory body will not find sufficient or correct for the filing process. Find out how to get the most out of your pre-sub meeting here. Later engagements are typically for either potential clinical study protocol reviews or finally the filing of the documentation for a request for approval. Most investors will want some guarantee that the timelines predicted by the company are reasonable, which will require the pre-sub meeting to determine if the FDA agrees with the path the company will take which can predict the timelines. 

Investors will want to hear your plans for the meetings with the FDA and make their decisions for initial or follow up investments based on the assumptions generated by the company. The goal for the weeks leading up to the meeting would be to create clear goals and questions you will discuss that include the concerns your investors will have, primarily the approval path (510(k), de Novo, PMA, etc.) and the time and investment necessary to clear the product. Once the meeting takes place, you are legally required to share bullet point notes of the discussion and the agreements. This will be sent to the FDA within the timeframe shared with you and the redlined feedback will be provided by the FDA. You will receive this form as the final communication for that specific meeting, with an option to set new ones. You can share this document with your investors as the final proof of regulatory feedback and agreements to your plans.


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