Device Research

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2022 Agenda

Friday, September 16, 2022 at 11:00 am to 11:45 pm ET                                                                              Track: Device Research
The Types of Device Trials, Billing and Reimbursement

This session will explore the types of device trials including Category A and B IDEs. Ms. Willenberg 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 with financial liabilities that they do not know about. 319
Presenter: Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP, CEO, Kelly Willenberg LLC

Friday, September 16, 2022 at 11:50 am to 12:35 pm ET                                                                                 Track: Device Research
Resources for Researching Medical Devices, Including Incidents, Clinical Trials, and Continuing Clinical Evaluation

The MEDDEV 2.7/1 Rev 4 (June 2016) and European Union (EU) Regulation 2017/745 (2017) have placed a new or renewed focus on the aggregation of data about subject and similar medical devices marketed in the EU, including characteristics, suspected device-associated incidents, clinical trials, and evaluations. The MDCG 2019-9 guidance has further directed the presentation, content, and validation of the summary of safety and clinical performance (SSCP) of such implantable and Class III devices in the EU. Ms. VanWyk will address resources for researching medical devices using databases maintained by US, EU, and other health authorities. She will additionally provide a brief overview of content and anticipated release information for SSCPs. 321
Presenter: Sara VanWyk, BS, MPH, CCRP, RAC, Principal Regulatory Scientist, RQM+

Thursday, September 15, 2022 at 2:05 pm to 2:50 pm ET                                                                           Track: Device Research
HDE as a Marketing Pathway

The diagnosis of a rare disease or condition can be a devastating occurrence for the patient and their family. Only a portion of the 7,000 known rare diseases have approved treatments in the United States. Rare diseases or conditions occur in a small number of patients. As a result, it has been challenging to gather enough clinical evidence to meet the FDA standard of reasonable assurance of safety and effectiveness. In order to address this challenge, Congress passed a provision in the Safe Medical Devices Act of 1990 that mandated a new regulatory pathway for products intended for rare diseases or conditions. This is the HDE Program. Ms. Headlee will discuss the CDRH Humanitarian Device Exemption (HDE) marketing pathway and IRB oversight of an HDE.  515
Presenter: Donna Headlee, RN, BSN, CCRP