In April 2020, the Food and Drug Administration announced a pandemic enforcement policy allowing mental health app developers to release certain treatment products without seeking authorization from the agency. With the end of the official public health emergency, companies that did so will now need to submit the products for FDA clearance and have them pass an early stage of review by early November — or remove the products from the market.
The enforcement policy afforded developers the ability to experiment with their products in the real world and advance their clinical, regulatory, and commercial strategies in clever ways. There’s no official count of how many companies released mental health apps under the policy, but STAT spoke to seven last year. Regulators have been discussing plans for how to eventually rein in the loosened rules since late 2021.
The end of the public health emergency on Thursday starts a countdown clock that may prove uncomfortable for companies, depending on their circumstances. (The FDA always reserves the right to deal with issues on a case-by-case basis, and there are additional reporting requirements and nuances in the final transition plan.)
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