Regulatory, Quality and Good Manufacturing Practices
For over 40 years, FDA's 510(k) process has provided a safe and efficient path to market for the vast majority of medical devices and diagnostics. Over that time, the process has continually evolved to adapt to the rapid pace of MedTech innovation and new health care issues. The 510(k) process may be poised for another evolutionary leap as FDA has proposed a number of significant changes to this bedrock regulatory paradigm. Learn from senior FDA management what the future holds for 510(k) and what industry thinks of this new phase in regulation.