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:
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Criteria |
Description |
Refer to Guidance |
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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 |
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Second Criterion |
The device also meets at least one of the following: |
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a. Represents Breakthrough Technology |
Section III.B.2.a |
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b. No Approved or Cleared Alternatives Exist |
Section III.B.2.b |
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c. Offers Significant Advantages over Existing Approved or Cleared Alternatives |
Section III.B.2.c |
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d. Device Availability is in the Best Interest of Patients |
Section III.B.2.d |
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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.
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References: