Today, most of the innovations making an impact on the healthcare need regulatory approval before market commercialization.
It's because the regulators want to make sure that the efficacy and safety claims of the innovation match it's intended use for which it received market approval.
This regulatory approval also applies to innovations that include digital health, software as a medical device (SaMD), Artificial Intelligence (AI), and APPs.
The approval process via the FDA involves the following methods.
- 510 (K) Exempt- You do not have to go through any approval process but are required to fulfill a list of notifications to the FDA. The FDA considers innovations that fall in the Exempt list as being safe and effective. A good example would be Enema kits.
- 510 (K)- You piggyback your innovation on an already approved innovation, showing FDA that it's intended use is the same, and the technology is the same. The approval rate of 100%. A good example would be some APPs on smartphones.
- De Novo- Here, the innovation is first of its kind and has no room to piggyback on an already approved innovation. It has to prove to the FDA that the innovation is safe and efficient as per its intended use. Approval becomes difficult, and the approval needs a lot of data. A good example would be an innovation using artificial intelligence in medical imaging. The approval rate is 50%. For now, Artificial Intelligence innovations fall in this category but may change as future innovations may piggyback on previously approved AI-based innovations.
- PMA-Pre-Market Approval- Here, it takes a long time as this the most stringent and most prolonged approval process. It includes any innovation that supports or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Approval times can range from 3years to 15 years, depending on the innovation, technology, completing of all in-vitro (bench tests), and in-vivo studies (animals and humans) data. A good example would be an innovation using artificial intelligence to predict advance heart attacks. The approval rate depends on the data of the innovation.
EU: European Commission via Notified Body
- Here unlike FDA, the process is different whereby your innovation goes to a notified body you appoint for review. The notified body is authorized by the European commission to give you the CE after reviewing your submission. The notified body does the review process before giving you the approval commonly called the CE mark.
- The letters "CE" are the abbreviation of the French phrase "Conformité Européene," which means "European Conformity."
- The approval process depends on the technology of the innovation and data supporting it and can anytime between 3 months-24 months.
Trilo Das, Regulatory affairs, pharma and medical devices expert
Professional Advisor at the Martin Trust Center for MIT Entrepreneurship