In the Know

Recent 510(k) Guidance Changes: What Medical Device Manufacturers Need to Understand
AGG Seminars & Webinars
September 16, 2014
Internet
Speaker(s) Alan G. Minsk

The attorneys of Arnall Golden Gregory LLP's Food and Drug Practice invite you to attend a complimentary one-hour webinar, “Recent 510(k) Guidance Changes: What Medical Device Manufacturers Need to Understand.”

The Food and Drug Administration recently issued a guidance document that, once again, offers insight into the agency’s decision-making process when reviewing 510(k) premarket notification applications. The guidance is important because, in some cases, it marks a sharp change from previous interpretation and practice in evaluating substantial equivalence – changes that should make medical device companies think anew as they develop regulatory strategy for new submissions. 

Register now to hear AGG's Food and Drug Practice leader, Alan Minsk, discuss the new guidance and areas of particular concern to the industry, and offer some observations.

Credits: This webinar is approved for 1 hour of CLE credit by the State Bar of Georgia.