Module 15 2022

19/05/2022

BREAKTHROUGH DEVICES: PROCESS

• Prioritized review • Management oversight • Faster pre-submission review cycle • Pre/post market balance

• If denied, traditional pathways are still available.

The Organisation for Professionals in Regulatory Affairs

13

BREAKTHROUGH DEVICES: ELIGIBILITY • Medical devices and device-led combination products are eligible • Subject to marketing authorization via Premarket Approval (PMA), De Novo, or 510(k) • Meets the breakthrough criteria specified in Section 515B(b) of the Federal Food, Drug & Cosmetic Act Criterion 1:

AND one of: Criterion 2A : represents a breakthrough technology Criterion 2B: no approved or cleared alternatives exist Criterion 2C : significant advantages over existing approved/ cleared alternatives Criterion 2D: Availability of device is in the best interest of patients

provide for more effective treatment or diagnosis of life threatening or irreversibly debilitating human disease or conditions; More effective requires data to support technical success and probable clinical effectiveness

The Organisation for Professionals in Regulatory Affairs

14

7