The US FDA Breakthrough Devices Program is a voluntary program for specific medical devices. Eligible devices are identified as providing more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. Manufacturers of such devices hence qualify to voluntarily join the US FDA Breakthrough Devices Program [1].

The primary purpose of the Breakthrough Devises Program is to allow patients and health care providers timely access to the latest treatment and technology. In this regard, FDA offers a number of benefits for breakthrough device manufacturers to accelerate the product development, assessment, and review while preserving the statutory standards for premarket approval.

1. Benefits include the following:
1. Interactive and Timely Communication,
2. Pre/Postmarket Balance of Data Collection,
3. Efficient and Flexible Clinical Study Design,
4. FDA Review Team Support and Priority Review,
5. FDA communicates Designation Criteria & Considerations Requirements,
6. Others; [2]

2. Definition of What Constitutes a Breakthrough Device:
Products must meet both criteria of table 1* below:



Refer to Guidance


First Criterion

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

Section III.B.1


Second Criterion

The device also meets at least one of the following:


a. Represents Breakthrough Technology

Section III.B.2.a


b. No Approved or Cleared Alternatives Exist

Section III.B.2.b

c. Offers Significant Advantages over Existing Approved or Cleared Alternatives

Section III.B.2.c

d. Device Availability is in the Best Interest of Patients

Section III.B.2.d

Table 1: The FDA definition for breakthrough device designation [1]

3. When and How to apply for the Breakthrough Devices Program:
The manufacturer can send a Breakthrough Designation request for their respective device at any time prior to sending any FDA registration submission (e.g.: PMA, 510(k), De Novo).

1. The manufacturers can request "Designation Request for Breakthrough Device" in Q-Submission.
2. FDA may search for candidates for the Breakthrough Devices Program and recommend these manufacturers to apply for the program directly.

Please kindly access the reference links below or directly ask the Qualtech team to provide you with further information and a consultation accordingly. It is our pleasure to assist you and we are looking forward to hearing from you.


  1. Breakthrough Devices Program
  2. GUIDANCE DOCUMENT: Breakthrough Devices Program