Getting Started with a New Medical Device
This question often pops-up in a first meeting with clients who have invented a new medical device: do I have to wait for FDA approval before I sell my device?
Absolutely! No medical device can be marketed and sold in the US without gaining pre-market approval from the FDA. Here is brief overview of the process:
- Register you facility (a broad range of persons/entities need to register with the FDA not just the manufacturer);
- Evaluate and classify your device (what CFR defines it? Is it Type I, II, or II? etc.);
- Identify a predicate device (is there a similar device already sold? Is your device substantially equivalent?);
- Work through the FDA’s recommend approval process for your device;
- Evaluate whether it’s prescription or over-the-counter (this may include a request in a 510(k) for the device to be OTC); and
- Submit your 510(k) (abbreviated 510(k) or other submission) and work with the FDA’s reviewer.
- No comments Posted in: Device Approval, Medical Device News (FDA)
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