Jun 3, 2016

The US Food and Drug Administration has accepted 17 high-risk and de novo medical devices into an expedited access program launched in 2015, according to the agency.

The FDA’s Expedited Access Pathway (EAP) was launched last year with the intention of getting cutting-edge medical devices and technologies to patients with few or no other treatment options faster than through conventional US registration routes. Now the FDA has provided a one-year update on its FDAVoice blog.

So far, the agency has issued 29 decisions regarding manufacturers' requests for EAP designation for their devices. Of those requests, 17 devices have been admitted into the program and 12 have been denied access. EAP designation decisions took 30 days on average, according to FDAVoice.

As Emergo initially reported in early 2015, the EAP program involves close and early collaboration between manufacturers and FDA personnel to minimize market access timeframes and costs to provide faster access to devices for particular patient populations.

Key qualifications for acceptance into the EAP program include:

  • The device must be able to treat or diagnose a life-threatening or irreversibly debilitating disease
  • The device should meet an unmet medical need, particularly by comparing the device to other treatment options available on the US market
  • The manufacturer must have in place a data development plan to be included in future submissions to the FDA; the plan is intended to help agency reviewers and the applicant to collaborate earlier in the registration process

The FDA notes that over the past year, EAP applicants that have developed preliminary proofs of principle but that have not yet begun formal studies of their devices have benefitted the most from the new program.

For more information on FDA clearance and approval of high-risk and novel medical devices, visit our service pages on FDA pre-sub consulting and Premarket Approval (PMA) registration, and download our whitepaper on FDA compliance for innovative and novel devices.


  • Stewart Eisenhart