Guidance for Industry and Food and Drug Administration Staff

Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions

Document issued on April 13, 2015.

The draft of this document was issued on April 23, 2014.

The Food and Drug Administration (FDA or the Agency) is introducing a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMAs) or de novo requests. FDA believes that the “Expedited Access Pathway for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions” (“Expedited Access Pathway” or “EAP”) program will help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness for premarket approval and the statutory standards for granting a de novo request consistent with the Agency’s statutory mission to protect and promote public health.

In some cases, patients may be willing to assume greater risk for earlier access to a medical device. This may be particularly true for patients with conditions for which no treatments exist or those who face serious or life-threatening conditions. FDA must ensure that if access to medical devices is expedited, FDA is reasonably assured the device is safe and effective. Reducing premarket data requirements while increasing postmarket requirements for devices subject to a PMA, when appropriate, can assist FDA in making medical devices available to patients sooner than if following the traditional premarket review pathway. Devices eligible for this pathway include new devices and existing devices for which a new indication is sought or when there is a change or modification in the device that could significantly affect the safety and effectiveness of the device [21 CFR 807.81(a)(3)(1)].

As part of this EAP program, FDA intends to provide, as resources permit, more interactive communications during device development and more interactive review of Investigational Device Exemptions (IDEs), PMA applications, and de novo requests. In addition, FDA intends to work interactively with the sponsor to create a data development plan specific to the device (“Data Development Plan”). The Data Development Plan should outline all data the sponsor intends to collect in support of device approval, including what data will be collected premarket and postmarket.

FDA’s EAP program contains features from CDRH’s Innovation Pathway, piloted in 2011 to facilitate the development and expedite the review of breakthrough technologies. In addition, the EAP program is based in part on FDA’s experience with the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) programs that are intended to facilitate and expedite development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening conditions (“FDA drug expedited programs”). However, while the EAP program incorporates some features of the drug expedited programs, it is a separate and distinct program tailored to devices and intended to further speed the availability of certain safe and effective medical devices that address unmet public health needs. Combination products may raise unique scientific and regulatory challenges. Sponsors intending to pursue approval of a combination product for which the device component may qualify for EAP designation should discuss the feasibility of using the EAP pathway with FDA as early as possible.

Download “Expedited Access for Premarket Approval and De Novo Medical Devices” UCM393978.pdf – Downloaded 215 times – 683 KB

You may download Federal Food, Drug, and Cosmetic Act (FD&C Act) here. 

Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).

FDA Webinar: 510(k) Final Guidance 28 July 2014

Expedited Access for Premarket Approval and De Novo Medical Devices