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

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

- Aishwarya Varpe

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.

Determining whether a product qualifies as a medical device and identifying its risk classification become important when navigating the FDA approval process. A product is classified as a medical device only if it meets the FDA's definition, which can be ambiguous and often requires further evaluation. This is because medical devices may closely resemble drugs, combination products, or wellness products, each following distinct regulatory pathways. Accurately classifying a device is crucial as it determines the level of regulatory scrutiny and the appropriate market approval process.

Fallout of Misclassification