FDA Offers Expedited US Market Pathway for Some High-risk Devices

 

A new proposal by the US Food and Drug Administration would allow faster market authorization for some high-risk medical devices targeting diseases that cannot be treated by current approved technologies.

The FDA describes its Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (EAP) program as a “collaborative approach” intended to reduce both premarket reviews and manufacturers’ product development timeframes.

EAP qualifications

The EAP program would be open to medical devices designed to treat or diagnose serious diseases or conditions for which no current approved treatment or diagnostic tool exists. Devices that either use “breakthrough” technology or provide clinically significant advantages to treat conditions or diseases more effectively than currently available products would also qualify.

Key EAP program features

Class III medical device manufacturers typically find the FDA’s premarket approval process expensive, lengthy and challenging, so what does the agency mean by “expedited access” for qualifying devices?

  • Interactive review: FDA officials would work closely with device sponsors to finalize data development plans before PMA submissions, and provide more guidance during product development and Investigational Device Exemption (IDE) phases.
  • Senior management involvement: FDA Office- and Center-level managers would participate in cross-disciplinary reviews of EAP submissions.
  • Case management: Agency case managers would be assigned to review applicants’ data development plans and liaise between sponsors and FDA reviewers.
  • Priority review: EAP submission would receive priority FDA reviews, and manufacturers would be obligated to collect pre- and post-market data, address agency requests and commercialized their devices in a “timely manner.”

In addition, FDA reviewers would accept abbreviated or alternative data from premarket clinical studies, as well as less manufacturing information from manufacturers with good quality management track records. In some cases, regulators would also skip manufacturing site inspections during EAP premarket reviews. (Inspections would be carried out within 12 months of final approval.)  

Post-market obligations

Since the EAP program would entail faster review and commercialization of qualifying devices, the FDA would require post-approval clinical and/or non-clinical studies of such devices as conditions of approval. Manufacturers would also have to meet periodic reporting requirements regarding safety, effectiveness and reliability of their devices.

The FDA will be accepting public comments on the EAP program over the next 90 days.

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