backJoin us for a discussion about the new FDA “Expedited Access Pathway” (EAP) program. The program is intended to help expedite the development and review of PMA devices and certain de novo 510(k) devices that have the potential to address unmet medical needs for life threatening or irreversibly debilitating conditions. We will address:
- The EAP program’s key components, including criteria for EAP designation, how manufacturers may access the program, potential benefits during premarket review, and possible challenges;
- Possible benefits and unintended consequences of earlier market access based on surrogate or intermediate clinical endpoints;
- Comparisons to the Accelerated Approval program for drugs;
- Potential implications for device manufacturers that take part in the EAP program, including post-market enforcement, tort liability, and withdrawal of FDA approval or clearance;
- Possible implications for coverage and reimbursement; and
- How tensions among the public, patients and policymakers regarding competing interests between growing demand for earlier access to breakthrough medical products, post-market expectations for product safety, and management of growing health care costs, are driving the discussion around the EAP program.
King & Spalding Presenters:
- David Farber
- Beverly Lorell, MD
- Seth H. Lundy
You do not have to be a client to attend, and there is no charge.
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Questions
If you have questions concerning this Roundtable Webinar, e-mail healthcare@kslaw.com.