FDA DRAFT GUIDANCE: EAP PROGRAM & PREMARKET/POSTMARKET DATA COLLECTION FOR PMA’S

In April of 2014 the FDA has released a long-awaited draft guidance proposing a new program which provides an expedited approval pathway for high-risk medical devices that are intended to treat serious conditions whose needs are unmet by current technology. In addition to the Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions or the “EAP” program, the FDA simultaneously released draft guidance entitled Balancing Premarket and Postmarket Data Collections for Devices Subject to PMA. The document outlines provisions specifying when data can be collected after product approval and FDA enforcement actions should these requirements not be met. It can be difficult for manufacturers to enroll patients in a trial once the product has been approved, therefore, the primary challenge for device companies will come when trying to meet the post-market data collection requirements in the FDA’s time frame.

• In-depth overview of EAP program and eligibility criteria
• Program benefits for industry and patients
• Clarifying manufacturer post-approval data collect policies
• Enforcement actions for non-compliance

Speaker:
Bethany J. Hills
Member of the Firm
Epstein Becker Green

Contact:

Brooke Akins | Manager, Market Intelligence | 312.224.1693 webinars@q1productions.com