*All times in Eastern Time Zone
12:00 – 1:00 pm ET Medical Device Research, Regulations and Path to Marketplace
Kathi Durdon, MA, CCRP, Executive Director at CNY Biotech Accelerator, Upstate Medical University
Ms. Durdon will start this SOCRA virtual mini-series off with an overview of medical device regulations and how risk plays a prominent role in product development, regulatory submission and ultimately use by patients and caregivers. This presentation will provide a brief history of medical device regulatory history, device classification, relevance of clinical trials and design for FDA submission, and the total product lifecycle of medical devices (TPLC).
12:0o to 1:00 pm ET The Types of Device Trials, Billing and Reimbursement
Kelly M. Willenberg, DBA, RN, CHRC, CHC, CCRP, Manager, Kelly Willenberg & Associates
This session will explore the types of device trials including Category A and B IDEs. We will discuss how you know what to bill to a payer and what you should expect to be reimbursed. Understand what you need to do to make sure your patients in research trials do not end up financial liabilities that they do not know about.
12:00 - 1:00 pm ET The Promise and Complications of “Broad Consent”
Mark Barnes, JD, Partner, Ropes & Gray, LLP
The revised Common Rule created a new version of consent entitled “Broad Consent,” meant to allow unrestricted future uses of identifiable data and biospecimens. The provisions for Broad Consent are complex and carry complications of such significance that few medical centers have adopted its use. This session will explore the history and meaning of Broad Consent, and will ask whether there are any circumstances in which its use is both practical and useful.