US FDA Breakthrough Devices Program

Expedited Access Pathway and Priority Review for medical devices are replaced by Breakthrough Devices Program. (Section 515B(b) of the Federal Food, Drug & Cosmetic Act)

This program speedup the breakthrough technologies development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization.

This program allows the manufacturer to interact with the FDA's experts to efficiently address topics/issues/concerns as they arise during the premarket review phase.

Devices subject to PMAs, 510(k) or requests for De Novo designation are eligible for breakthrough device designation if both of the following criteria are met: statutory criteria

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

2. The device also meets at least one of the following:

a. Represents Breakthrough Technology

b. No Approved or Cleared Alternatives Exist

c. Offers Significant Advantages over Existing Approved or Cleared Alternatives

d. Device Availability is in the Best Interest of Patients

Breakthrough Technology: Consider technological advances or new use of an existing technology. Consider potential to lead to clinical improvement.

Manufacturer can submit breakthrough designation at any time prior to sending your marketing submission  by submitting a "Designation Request for Breakthrough Device" Q-Submission.

Content of Application:

• Device description
• Proposed indication for use
• Regulatory history
• How your device meets the statutory criteria for a Breakthrough Device
• What type of marketing submission you plan to submit to the FDA for your device

Timelines:

Deficiency letter- within 30 days of receiving your request

FDA's decision to grant or deny- within 60 days of receiving your request

References:

Guidance Breakthrough Devices Program:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program

Device advice Breakthrough Devices Program: https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#s3