The manufacturers of medical devices are required to meet a wide range of regulatory requirements before their products can hit the market.
At the Law Office of Bradley Byars, our healthcare attorneys help our medical device company clients meet these licensing requirements, including matters like:
- Determining the correct FDA classification (Class 1, II, or III)
- Labeling requirements
- Establishment registration
- Medical device reporting requirements (MDR)
- Premarket notification (510(k))
- Quality system regulation, good manufacturing practices, and other regulatory requirements
- Premarket approval (PMA)
- 513(g) letters if the company believes the product is not a medical device