Medical Devices

Expedited Access Pathway Program

The FDA recently published draft guidance on the Breakthrough Devices program. You can submit your comments on the draft guidance, which describes the policies that the agency intends to use to implement the program, by December 26, 2017.

On December 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.

The Breakthrough Devices Program expands upon the Expedited Access Pathways (EAP) program by making future 510(k)s eligible as well as Premarket Approval applications (PMA) and De Novo device submissions. All participants previously granted EAP designation will have designation as Breakthrough Devices; no separate action is necessary.

For any questions about the Breakthrough Devices program or EAP, please contact

The Expedited Access Pathway (EAP) program is a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket notification (510[k]) or requests for De Novo designation. The program is detailed in the FDA's guidance Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.

Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA's PMA approval standard of reasonable assurance of safety and effectiveness, the standards for granting De Novo requests, or any other standards of valid scientific evidence.

Components of the program include priority review, more interactive review, senior management involvement, and assignment of a case manager. The extent to which the FDA provides these features depends on the availability of resources.

Participation in the EAP program is only at the request of the sponsor and with the FDA's agreement. If the FDA determines that a device may be eligible for this program and the sponsor has not yet submitted a Pre-Submission (Pre-Sub) requesting EAP Designation, the FDA intends to inform the sponsor of the program. For details on how to request feedback from the FDA, see FDA's Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff

Devices eligible for EAP Designation

Devices subject to premarket approval applications (PMAs), premarket notification (510[k]) or requests for De Novo designation are eligible for EAP designation if the following criteria are met:

  1. Provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.


  1. The device meets at least one of the following criteria:
    1. Represent breakthrough technologies;
    2. No approved or cleared alternatives exist;
    3. Offer clinically meaningful advantages over existing approved or cleared alternatives including the potential, when compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients' ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or
    4. The availability of which is in the best interest of patients.

When to Request EAP Designation

The FDA strongly recommends sponsors interested in participating in this voluntary program contact the FDA early in the development of their device. In most cases, a sponsor should request EAP designation prior to beginning an IDE pivotal study so the FDA and the sponsor can make sure the data being collected in the pivotal study are appropriate to include in the device's marketing submission.

Sponsors who are developing a device that may qualify for EAP designation and would like to be considered for the program should submit a Pre-Sub following the procedures described below and explained in detail in the EAP guidance.  The FDA encourages sponsors to contact the appropriate division/branch to alert them of their plan to submit a request for EAP Designation prior to submitting it or at the time of submission.

Submitting a request for EAP designation

The request for EAP designation should be a standalone submission (i.e., no other requests are included with the request for EAP designation) and submitted as a Pre-Sub to the appropriate Center’s Document Control Center. The current mailing address for CDRH’s DCC and a link to CBER’s DCC’s mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

Pre-Subs are not subject to a user-fee. However, you must submit an eCopy (per section 745(A)(b) of the FD&C Act).  For information about how to comply with the eCopy program, please see the FDA's guidance document eCopy Program for Medical Device Submissions.  

Submissions should be written in the English language. Any material in a foreign language should be accompanied by an accurate and complete English translation.

Content of a submission requesting EAP designation

A Pre-Sub requesting EAP designation should include the following information:

  • Cover Letter clearly noting the purpose of the Pre-Sub stated as: "Request for Inclusion in the Expedited Access Pathway Program, as described in the Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions Guidance, issued on April 13, 2015" and a statement of whether you believe you are eligible as a PMA or de novo candidate.
  • Table of Contents
  • Device Description
  • Proposed Intended Use/Indications for Use
  • A discussion of how your device meets the EAP eligibility criteria
    • Include a discussion of why the device meets the EAP criteria described in section III.C of the EAP guidance, including any relevant supporting documentation
  • A draft Data Development Plan (Optional)
    • A description and summary of the data collection plan, including study synopses and study design.
      • Outline of nonclinical & clinical testing, planned or already completed
      • Proposed Labeling
      • Summary of Nonclinical Studies, including study design & protocol, as available
      • Summary of Clinical Studies, proposed or completed
    • Explanation and justification for the proposed balance of premarket and postmarket data collection, if applicable.
    • A timeline for the development and marketing of the device, and for the postmarket data collection, if applicable.

The Agency developed two Data Development Plan examples, Example 1 and Example 2 to offer a format for the organization of the information in a draft Data Development Plan.

These examples are equivalent and differ only in formatting. The information provided in these examples does not create new requirements or expectations for affected parties, nor are they intended to convey FDA's recommended approaches or guidance. Rather, these are examples of how the Data Development Plan information recommended in the EAP guidance could be organized.

FDA Response to requests for EAP designation

  • The FDA intends to notify the sponsor of its determination in writing within 30 days of receipt of a request for EAP designation.
  • If there is insufficient information for the FDA to make a decision about EAP designation, the FDA may request the sponsor submit additional information.
  • In response to such request, any additional information provided by the sponsor should be submitted as a supplement to the Pre-Sub.
    • If the FDA requests additional information from the sponsor, the FDA will notify the sponsor in writing whether or not EAP designation is granted within 30 days of the date of the request for additional information.
    • If the FDA has not received enough information in time to make a decision by 30 days after a request for additional information is sent, the FDA intends to deny the EAP designation.

Benefit-Risk considerations

The FDA's Benefit-Risk Guidance explains the principal factors that the FDA considers when making benefit-risk determinations in the premarket review of certain medical devices, including devices subject to PMAs. Two of the factors that the FDA may consider as part of making benefit-risk determinations are postmarket data collection and uncertainty.

The FDA may accept a greater degree of uncertainty of the benefit-risk profile for these devices if the uncertainty is sufficiently balanced by other factors, including the probable benefits for patients to have earlier access to EAP Devices (e.g., devices that treat a life-threatening disease when no alternative treatments are available), and adequate postmarket controls to support premarket approval.

As part of the FDA's benefit-risk determination, the FDA intends to weigh the device's impact on patient health, including the probable benefit of earlier access to the device, against the probable risk of harm to patients from the device should subsequent data collection demonstrate that the device is ineffective or unsafe.

Role of Postmarket Data for EAP Devices Subject to PMA

As part of the EAP program, the FDA intends to work interactively with the sponsor within the benefit-risk framework discussed in the FDA's Benefit-Risk Guidance and in accordance with statutory and regulatory requirements, to determine whether certain data may be collected postmarket rather than premarket.

Getting the right balance between premarket and postmarket data collection - specifically, where appropriate, a greater reliance on postmarket collection - can reduce the extent of premarket data submission and directly impact when patients will have access to high-quality, safe and effective medical devices.

Section 513(a)(3)(C) of the FD&C Act requires the FDA to consider the use of postmarket controls in lieu of collecting and reviewing all effectiveness data prior to PMA approval.  In addition, section 513(a)(3)(D)(ii) of the FD&C Act (the "least burdensome provision") specifically provides:

Any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary that such data are necessary to establish device effectiveness.  The Secretary shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval.

The consideration of postmarket information as part of premarket review is discussed in the FDA's Benefit-Risk Guidance as one of the principal factors that the FDA considers when making benefit-risk determinations during the premarket review for devices subject to PMA, and is consistent with the FDA's guidance The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles ("Least Burdensome Guidance"), issued October 4, 2002.

Postmarket requirements as conditions of approval for PMAs under the EAP program

The FDA intends to impose postmarket requirements, including requiring post-approval studies, as a condition of approval for devices subject to a PMA when applicable.

EAP designation denials

Even if your device does not qualify for EAP designation, you can utilize the pre-submission process to request feedback from the FDA. Please see FDA's Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff for details on how to request feedback from the FDA.

EAP designation revocation

An EAP designation will not be revoked solely because a similar product is approved or a de novo request granted. The FDA may revoke an EAP Designation at any time prior to approval upon written notice to the sponsor if the FDA determines that:

  • Based on information available, the device is no longer eligible for an EAP Designation according to the EAP criteria outlined in Section III.A of the guidance; or
  • The information submitted in support of a request for EAP Designation, including, without limitation, the Pre-Sub package, or any related premarket submission contained an untrue statement of material fact or omitted material information, including false statements relating to data collection.

As a general matter, the FDA does not intend to revoke EAP Designation for other reasons.

Additional Information


Page Last Updated: 09/05/2018
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