FDA Regulations for AI in Medical Devices: Comprehensive Guide
The FDA currently regulates AI in medical devices through existing pathways (510(k), De Novo, PMA). However, it has issued draft guidance and new discussion papers to address AI-specific risks, namely bias, transparency, and continuous learning. In this blog, we have...
Clinical Data Requirements for U.S. FDA Submissions
The FDA’s clinical data requirements are designed to ensure that medical devices are proven safe and effective before reaching patients. Clinical data refers to evidence collected from human studies, including trials, observational studies, and post‑market...
Draft Drugs, Medical Devices & Cosmetics Bill 2026: India’s Pharma & Medical Device Regulation Overhauled
Government plans to replace the Drugs & Cosmetics Act, 1940. This highlights a major regulatory shift. The Draft Drugs, Medical Devices & Cosmetics Bill, 2026 aims to replace the 1940 Act. It will consolidate drug, device, and cosmetic regulation under one...