4. Startups are choosing less burdensome regulatory paths.
Nearly half of the startups planned to market their products with 510(k) clearance, 13% with de Novo approval and 8% with premarket approval. About 30% of the startups said they would not need regulatory approval for their products.
Infectious disease and emergency medicine were the most common primary medical areas for startups on the 510(k) pathway. Preventative medicine/wellness was the top area for unregulated products, which led Deloitte to hypothesize that they were likely digital apps.
“It is possible that products that do not currently require approval might need approval in the future,” the report said.
