CE Vs FDA for Novel devices:FDA Breakthrough Device program- For MEDICAL DEVICES and Device-led combination products
You have a novel device? You claim your device offers Significant Advantages over Existing devices? It seems you are better off today searching market approval in the USA before you start in Europe. Indeed, with only 4 NBs accredited for the MDR, almost no common specifications published, no harmonised standards with the MDR released, Europe stays " Challenging " and time lines remain an uncertainty. Some NBs have told me that review for approval will take at least 1 year. The other challenge, will be receiving information on what NB are expecting to see as data. it is true that MDR does mention a Clinical Evaluation consultation procedure for certain class III and Class IIB devices (MDR-Article 54-55). This consultation however, is only for the clinical evaluation, and is not yet set in place. How long will it take to get feed back for the relevant experts/NBs before setting up ones Clinical Investigation to support market clearance?
Therefore the FDA Breakthrough Device program- For MEDICAL DEVICES and Device-led combination products seems to be the solution for market release in todays regulatory environment.
The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices.
It's a two-Step Process With Two Main Criteria:
Step #1: submit a designation request to apply for entry into the program via the Q-Submission process -independently if your device is a PMA- 510(K) or a De NOVO)
(Ref: https://www.fda.gov/media/114034/download)
They are 2 criteria to be eligible:
a. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions
b. The device also meets at least one of the following:
- - Represents Breakthrough Technology
- - No Approved or Cleared Alternatives Exist
- -Offers Significant Advantages over Existing Approved or Cleared Alternatives
- - Device Availability is in the Best Interest of Patients
Step #2: after the device has been accepted for inclusion, the FDA will assign special device review teams to evaluate submissions on a timely basis. This step includes senior management engagement to facilitate efficient development and regulatory review of the device, as well as to resolve issues.
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