When preparing for a medical device submission to the FDA, sponsors always ask, “What do I need to do?” The answer is, it depends. Expectations have changed. FDA guidance clarifies some while others require a tailored approach. Whether developing a new medical device, modifying your own existing device, or coming to market with a “me too” device to take down the competition, you will need data to support performance and safety.
Would you be surprised that a good amount of the project team time is spent debating the testing approach, even when there are clear standards and guidance available? Here are some common team member responses when they hear, “Biocompatibility testing per ISO13485:2016 is required.”
- The scientist. “These materials are well characterized in the literature and are biocompatible.”
- The project manager. “I looked up our competitor’s 510(k) and they didn’t have to do biocompatibility.”
- The sales manager. “Let’s submit the 510(k) with a rationale and do the testing if the FDA asks for it.”
- R&D. “Our raw material suppliers will give us a certificate of conformance for the materials that they are medical grade and non-toxic.”
- “Our contract manufacturer also makes this same product for our competitor, how can we use this information?”
Naturally, everyone is invested in expedience and economy. Each team member represents their functional priorities and brings their knowledge and experience to the table to help the project succeed. However, the FDA expects to review information (data) so they can find your product substantially equivalent or approve your PMA. So the discussion/regulatory strategy begins with two questions:
- What testing best demonstrates the safety and efficacy of our product?
- How much is required?
Any available information can be reviewed to determine its usefulness. Whatever information is used to support the submission must be truthful, supported by data, and conclusions should be generally and broadly accepted.
Choosing the best regulatory strategy is a collaborative effort and folks can get pretty creative when they want to save money. With all due respect to logical conclusions and expert opinions, the FDA wants data. When each team member strives to understand others’ perspectives, bringing your products to market and keeping them there can be a simple process.
I will be presenting more on this topic at the Midwest Society for Quality Assurance Annual meeting August 6-7, Indianapolis, Indiana. https://www.mwsqa.org/AnnualConference I will provide insight into some of the most common trends in medical device submissions including GxP, Standards, Real-World Evidence, animal testing, and clinical evaluations.
