The Food and Drug Administration’s quick approval of the Apple Watch has brought industry scrutiny. Most medical device companies wait months and months, if not years to see their devices approved by the FDA. Not to mention, a de novo device usually has the longest running time of the FDA pathways available. This has left many in the industry believing that the tech company received preferential treatment.
Apple submitted their De Novo application (for novel medical devices) on August 9thand 19thto then see approval of both on September 11th. That is almost unheard of in the medical device industry. There are cases where, if the company meets with FDA in advance of the submission and has thorough discussions, their application will take less time, but this is still exceptionally fast.
The coincidental scheduling of the Apple keynote on September 12thto release the new watch and its apps doesn’t help the case. Whether the FDA sped up the process or not, the device is out and we can confirm – it’s really cool!