NAMSA is excited to present a special joint webinar with the Medical Alley Association (MAA). Learn direct from medical device industry experts, Ken Skodacek (Policy Analyst), FDA Center for Devices and Radiological Health; and Seth Goldenberg (Director of Product Development Strategy), NAMSA, as they discuss the FDA/CMS Parallel Review Process.
There are numerous stakeholders that must be considered when bringing a medical device to market. These include regulatory agencies, healthcare payers, healthcare providers, patients, and healthcare technology assessment organizations, just to name a few.
While regulatory agencies such as the FDA focus on safety and efficacy, payers and providers consider other criteria, including healthcare outcomes and patient value. Gathering scientific evidence and conducting clinical investigations remains a long and expensive process. As a result, it is important to consider feedback from all stakeholders prior to initiating device approval and reimbursement strategy in order to maximize ROI.
To assist with the challenge of meeting various stakeholder requirements, the FDA’s CDRH established the Payer Communication Task Force (PCTF) to support opportunities like the FDA/Centers for Medicare and Medicaid Services (CMS) Parallel Review Program. This helps to not only engage public payers such as CMS, but also provides opportunities to engage private payers and healthcare technology assessment organizations through the FDA’s Pre-Submission Program.
Join NAMSA for this upcoming webinar with the MAA as they address the following questions:
Time will also be allotted for Q&A.