Medical Device Classification and FDA Approva:What Startups Need to Know

For many innovators, the United States represents a key market, being the world’s largest for medical devices.

- Aishwarya Varpe, Associate- Regulatory Services, Venture Center

However, entering the US market requires navigating the US Food and Drug Administration’s (FDA) stringent regulatory landscape, where accurate device classification is crucial. To assist innovators, the Regulatory Information and Facilitation Center (RIFC) at Venture Center, Pune has released a whitepaper early this year that offers practical insights, featuring examples of devices developed by Venture Center-supported startups to illustrate how medical devices are categorised based on risk.

Under the FDA, the Center for Devices and Radiological Health (CDRH) oversees the regulation of medical devices. It ensures that patients and healthcare providers have timely and sustained access to safe, effective, and high-quality medical devices, including radiation-emitting products.

To assist innovators, the Regulatory Information and Facilitation Center (RIFC) at Venture Center has released a whitepaper titled "Classification of Medical Devices in the US", providing a simplified step-by-step guide in the form of a flowchart on determining device classification (Class I, II, III), regulatory pathways (510(k), De Novo, PMA), and key compliance requirements with examples. The whitepaper also offers practical insights, featuring examples of devices developed by Venture Center-supported startups to illustrate how medical devices are categorised based on risk.