FDA fast access a possibility? The FDA has an EAP (Expedited Access Pathway) program.
This a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket notification (510[k]) or requests for De Novo designation.
Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA’s PMA approval standard of reasonable assurance of safety and effectiveness, the standards for granting De Novo requests, or any other standards of valid scientific evidence.
It’s worth noting that to gain the approval they have to meet the following criteria:
· Provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
AND ONE OF THE FOLLOWING:
· Represent breakthrough technologies.
· No approved or cleared alternatives exist
· Offer clinically meaningful advantages over existing approved or cleared alternatives including the potential, when compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or the availability of which is in the best interest of patients.