FDA Releases New Guidance Documents

The U.S. Food and Drug Administration (FDA) recently released two guidance documents that agency officials believe will accelerate U.S. market entry for certain medical devices.

The first guidance outlines the Expedited Access Pathway (EAP) for medical devices that treat life-threatening or irreversibly debilitating diseases or conditions with few or no alternative treatment options. Under the EAP, first announced in early 2014, the FDA will work closely with manufacturers to reduce timeframes and costs associated with premarket approval.

The second guidance clarifies current FDA policy on pre- and postmarket data collection. It explains situations in which postmarket data collection is appropriate for premarket approval (PMA) applications, both in EAP and non-EAP situations, and provides numerous examples.

Under terms of the EAP, a device manufacturer may submit an application for the special designation if no other alternative treatment exists or if the device uses a novel technology that outperforms existing treatment options. Consideration also will be granted to devices when early availability serves the patient’s best interest.

The EAP guidance specifically applies to PMA or de novo applications and will foster “more interactive communications during device development and more interactive review of Investigational Device Exemptions, PMA applications, and de novo requests,” resources permitting.

If accepted, the device will be given priority status and could be assigned an FDA case manager. The FDA and the manufacturer also will work together to create a data development plan (DDP) that could shift the burden of some premarket data requirements to postmarket.

Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, explained in a blog post that the DDP “will shift premarket data collection to the post-market setting, to the extent appropriate, taking into account the public health benefit of these devices, while still meeting the U.S. approval standard of reasonable assurance of safety and effectiveness.”

Shuren said the FDA will be willing, in some cases, to accept a reasonable degree of predictability based on data collected from surrogate or intermediate endpoints under the condition that the manufacturer provide more conclusive data postmarket. “Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device,” Shuren wrote in an April 8 blog.

Janet Trunzo, senior executive vice president for technology and regulatory affairs at the Advanced Medical Technology Association (AdvaMed), said in a prepared statement that she “commends the agency for its efforts to explore supplementary review pathways to provide more timely patient access to technologies.”

However, some experts believe these new developments are indicative of an FDA that is feeling increasing pressure from Congress to expedite medical products at the expense of safety. Diana Zuckerman, president of the National Center for Health Research, contends the new measures could “weaken safeguards that are intended to protect patients from unsafe medical products.”

Furthermore, a blog post published by the consulting firm Emergo Group warned that the value of the program would hinge on the FDA’s ability to provide the necessary resources.

“How extensive EAP features are for registrants, however, depends on the availability of agency resources—something manufacturers should keep in mind when deciding whether to sign up for EAP review,” it stated.

The program began on April 15, when the FDA started accepting EAP applications. Manufacturers can expect a decision or request for additional information 30 days following submission.