When to Submit a 510(k) for a Change to an Existing Device
When: Tue., Aug. 14, 9 a.m.-12 p.m. 2018
Overview:
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k)
Why should you Attend:
This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the "when to submit" decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.