FDA releases action plan on artificial intelligence software

This column reviews details on recent recalls, warnings, and approvals.


A global recall of all unused inventory of the LOTUS Edge Aortic Valve System by Boston Scientific Corporation due to complexities associated with the product delivery system. The recall is related solely to the delivery system, and there is no safety issue for patients who currently have an implanted LOTUS Edge valve. Rather than develop and reintroduce an enhanced delivery system, the company is retiring the entire LOTUS platform.

A recall of one lot of cisatracurium besylate injection USP (10 mg per 5 mL) by Meitheal Pharmaceuticals Inc. due to mislabeling as phenylephrine hydrochloride injection USP (100 mg per 10 mL). There have been no reports of related adverse events. Recalled products were shipped on Aug. 19, 2020, and distributed to wholesalers nationwide.


A new action plan on artificial intelligence/machine learning-based software as a medical device. The plan describes the FDA's approach to oversight of such software, which will include further developing the proposed regulatory framework, supporting the development of good machine learning practices to evaluate and improve algorithms, fostering a patient-centered approach, and advancing real-world performance-monitoring pilots.

COVID-19 updates

An import alert on all alcohol-based hand sanitizers from Mexico. Over the course of the pandemic, the FDA has seen a sharp increase in hand sanitizer products from Mexico that were labeled as containing ethanol but tested positive for methanol contamination. FDA analyses found that 84% of samples taken from such products in April through December 2020 were not in compliance with the agency's regulations. Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and agency staff may detain the shipment.

Reissued EUAs for decontamination systems that are authorized to decontaminate compatible N95 respirators used by health care personnel. Under the reissued EUA, certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times.


Cabotegravir and rilpivirine, injectable formulation (Cabenuva), as a complete regimen to treat HIV-1 infection in adults to replace a current antiretroviral regimen. The drug is indicated for patients who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. This is the first approval of an injectable, monthly complete regimen for HIV-infected adults. The FDA also approved a tablet formulation of cabotegravir (Vocabria), to be initially be taken in combination with oral rilpivirine (Edurant) for one month to ensure tolerance before switching to the extended-release injectable formulation. In two trials of 1,182 adults with HIV who were virologically suppressed before treatment, patients continued to show virologic suppression with no clinically relevant change from baseline in CD4+ cell counts. The most common adverse reactions were injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.

First-time generic approvals

Ritonavir capsules USP (100 mg) in combination with other antiretroviral agents for the treatment of patients with HIV-1 infection. (Brand name: Norvir)

Asenapine sublingual tablets (2.5 mg, 5 mg, and 10 mg) for the treatment of adults with schizophrenia and patients with bipolar I disorder. (Brand name: Saphris)

Efinaconazole topical solution (10%) for the topical treatment of patients with onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. (Brand name: Jublia)

Note: The FDA states that drugs are not always commercially available immediately after approval.