You may not have been able to make it to the Demystifying Medical Device Classification & Approval with MITRE webinar, hosted by FORGE, but we are here to give you the inside scoop.
Our event host and industry expert, Iris Sherman, began her career in the startup space. Have you ever heard of a little known product called Allegra? Well, she was on the founding team. She also worked directly with the FDA to build a medical device approval process for sub-Saharan Africa. She knows the ins and outs of the regulatory process for medical devices, and FORGE was fortunate to share her wisdom with our attendees! .
Below we have attached not only her slides, but also a recording of her presentation. However, if you need a quick summary, here it is:
1. Know your market
When determining your product’s class, use your competitors as examples. While not all pathways require a predicate device, comparing your product to those already on the market is a very smart option and can streamline your process. Those devices made it through FDA approval because their applications met the FDA’s strict guidelines.
Using your competitors application date and K number, you can often find full 510k Summaries on Google. Don’t be afraid to copy language from those applications verbatim. It is still up to you to prove the claims.
2. Document everything
The FDA is interested in stopping recalls before they happen. You must list every possible malfunction or user error during the regulatory process. The FDA wants to be sure you could trace any future issue back to its cause and that you have systems in place to address concerns.
Therefore, once you have passed the ideation phase and are in the concept development phase, all of the prototype elements MUST be documented, along with blueprints, testing results, iterations made to the prototype… everything!
3. Choose the right pathway
Plenty of companies go bankrupt while misguidedly following a 510k approval process. A Pre-Market Approval (PMA) pathway is reserved for Class III devices, the ones with the most risk. A DeNovo pathway, however, is appropriate for devices that do not fit into any particular class or have no equivalent device that is currently marketed. It’s a straightforward application that places emphasis on safety and efficacy, rather than finding a predicate device. Essentially, make sure you are headed in the right direction before you spend money.
4. Collaborate with the FDA
When in doubt, apply for an “informational meeting” with FDA reviewers. During these meetings you can provide an overview of ongoing device development and familiarize reviewers with the significance of your device. You will not receive feedback during the meeting, but can submit a written formal request for feedback.
5. Prepare for a long process
Lastly, FDA approval is lengthy. If absolutely every step of the 510(k) submission process goes perfectly and there are no questions, it will take 100 days. Most likely, it will be longer than that. Sherman estimates around 150 days, so be sure to prepare for that timeline internally and inform stakeholders before you submit.