India, April 30 -- 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 insight...