The U.S. Food and Drug Administration has announced 25 changes to the 510(k) process to be implemented beginning in March of this year. These changes will directly impact any investor in a medical device company. Certain of the changes should help to clarify and “unstick” the FDA 510(k) clearance process that has been detering some investors from investing in medical device companies. However, these changes may lengthen and complicate the device clearance process so investors should be aware of potential changes and future issues.
Join McGuireWoods for an interactive discussion of the recent changes, the time line involved, and how it will impact medical device companies and medical device products.
Topics to be Covered on the Webinar:
- Insight into each proposed FDA action.
- Understanding the purposes behind the changes and their potential impact on device manufacturers.
- Preparing for dialogue with FDA to educate them on your stakeholder issues, while new Draft Guidances and policies are being formulated and before they are set in stone.
To register for this complementary webinar, click here.