FDA releases plan on artificial intelligence software

Recalls, updates, 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, as the valve continues to achieve positive and clinically effective performance postimplant. There is no safety issue for patients who currently have an implanted LOTUS Edge valve. Rather than 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.

Image by Getty Images
Image by Getty Images

A recall of one lot of ketorolac tromethamine injection USP (30 mg/mL in 2-mL vials) by Fresenius Kabi USA due to the presence of particulate matter in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

A recall of all lots of chlorhexidine gluconate oral rinse USP (0.12% in 15-mL unit-dose cups) by Precision Dose Inc. due to potential contamination. The company was notified by the manufacturer, Sunstar Americas Inc., that the product may be contaminated with Burkholderia lata. No related adverse events have been reported. Recalled products were distributed nationwide to pharmaceutical wholesalers.

A recall of one lot of Soho Fresh 70% Rubbing Alcohol by Essaar Inc. due to contamination with methanol. An FDA analysis revealed the contamination, which poses a risk of methanol poisoning, particularly among young children who accidently ingest these products and adolescents and adults who drink them as a substitute for alcohol. No related adverse events have been reported. Recalled products were distributed nationwide to retail stores.


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 supporting good machine learning practices to evaluate and improve algorithms, fostering a patient-centered approach (including device transparency to users), and advancing pilot studies in the real world.

COVID-19 updates

A letter alerting clinicians and clinical laboratory staff that the FDA is monitoring the potential impact of SARS-CoV-2 viral mutations, including the emerging B1.1.7 variant, on authorized SARS-CoV-2 molecular tests. False-negative results can occur if a mutation occurs in the part of the virus's genome assessed by a molecular test. The FDA believes the risk that these mutations will impact overall testing accuracy is low. To ensure tests remain accurate, the agency is working with test developers and analyzing data on all currently authorized molecular tests.

A safety communication about the risk of false results, particularly false negatives, with the Curative SARS-Cov-2 test. To reduce the risk of false negatives, it is important to perform the real-time reverse-transcriptase polymerase chain reaction test in accordance with its emergency use authorization (EUA) and authorized labeling, the FDA said.

An import alert on all alcohol-based hand sanitizers from Mexico. Over the course of the pandemic, the agency 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 systems authorized to decontaminate compatible N95 respirators used by health care personnel. Under the reissued EUA, certain systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times.

First-time generic approvals

Ritonavir capsules USP (100 mg) in combination with other antiretroviral agents for the treatment of 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 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.