March 13, 2021 – The Digital Therapeutics Alliance (DTA) submitted comments related to Health and Human Services’ ‘Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements’ (86 FR 4088), published on January 15, 2021.
Although DTA does not support HHS 86 FR 4088 as currently written, we propose the following steps for HHS and FDA:
- DTA believes that FDA provides critical value to patients, clinicians, and payors in assessing and validating the safety and efficacy of digital therapeutic devices – some of which are included in this proposed rule. Since we cannot support HHS 86 FR 4088 as presented, HHS and FDA should work with DTA and similar organizations to develop appropriate and necessary pathways for digital therapeutic (DTx) product review and access in the post-public health emergency (PHE) period. This will ensure a greater balance between patient access and appropriate oversight of DTx clinical indications, product claims, safety, and efficacy.
- It is also necessary for the agency to develop a continuity of care pathway for patients, caregivers, and clinicians who’ve had access to certain digital therapeutics during the PHE period under the April 2020 Emergency Use Authorization (EUA). Given the importance of this discussion, DTA hopes to work directly with FDA and HHS to develop the necessary solutions and pathways.
DTA’s full comments are provided here.