As the FDA grinds through the comments submitted in response to their proposed rule for medical device data systems (MDDS), the market awaits the final rule. Regardless of changes between the proposed and final rules, vendors who may be regulated under the new rule will have limited time to prepare.
Awhile back, I was contacted by ComplianceOnline to author a webinar on the FDA's proposed MDDS rule. After some discussion, we agreed on the following pithy title: The FDA’s proposed Medical Device Data System (MDDS) rule and its implications for currently regulated and unregulated vendors and providers. The key objectives for the webinar are to provide clairification on the proposed rule and explore the consequences for those involved with MDDS - vendors and hospitals.
You can read a description and register for the webinar here. Attendees are encourage to submit questions - which I will answer during and after the webinar.
Alas, the webinar is not free. But compared to what it would cost in my time to lay out the proposed MDDS rule and its implications in detail, the price is a bargin.