FDA Roundup: October 18, 2022

SILVER SPRING, Md., Oct. 18, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• On Tuesday, the FDA issued an emergency use authorization (EUA) for the first over-the-counter molecular test authorized for use with saliva specimens to Aptitude Medical Inc. for their Metrix COVID-19 Test, a single-use molecular in vitro diagnostic test for the detection of SARS-CoV-2. This test is authorized for non-prescription at-home use with anterior nasal (nares) swab and saliva sample, self-collected from people aged 14 years or older, or adult-collected from people aged 2 years or older, including people without symptoms or other epidemiological reason to suspect COVID-19. Negative test results from saliva samples are presumptive and negative test results from anterior nasal (nares) swab samples from asymptomatic individuals should be treated as presumptive. Negative test results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative test results should be considered in the context of a person's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19 and confirmed with additional testing, if appropriate.

• On Monday, the FDA provided updates about the final results of the postmarket surveillance ("522") study on Coloplast transvaginal mesh for pelvic organ prolapse (POP). The study results showed the mesh had similar outcomes to native tissue repair (repairs without the use of mesh) at 36 months. However, devices of this type for transvaginal POP mesh repair present potential additional risks compared to native tissue repair, including mesh exposure and erosion. Based on currently available information, the FDA maintains that these devices do not have a favorable benefit-risk profile. Although these devices are no longer commercially available in the US, the FDA required the manufacturer to continue follow-up of previously implanted patients already enrolled in its postmarket surveillance study.

• On Monday, the FDA reminded consumers that the influenza, or flu, vaccine is the year-round work of highly skilled microbiologists, epidemiologists, physicians and other public health experts. Flu seasons and severity are unpredictable. Annual vaccination is the best way to prevent the flu for people ages 6 months and older.

• On Friday, October 14, the FDA's Center for Tobacco Products announced that, to date, all non-tobacco nicotine product applications submitted by May 14 have been processed, and 95 percent have been assessed to determine if they meet the minimum requirements to be accepted for further review. As of Oct. 7, the FDA has issued Refuse to Accept letters for more than 889,000 products in applications that do not meet the criteria for acceptance. The FDA has also accepted over 1,600 applications, with the vast majority being for e-cigarette or e-liquid products, and has issued a total of over 60 warning letters to manufacturers, including brands popular among youth such as Puff Bar. The manufacturer warning letters include those for products for which an application had been submitted but where the agency has taken a negative action, such as a Refuse to Accept Letter.

• On October 14, 2022, the FDA authorized the marketing of the Cooral System, a device intended to cool the inside of the mouth (oral mucosa) during chemotherapy cancer treatment to reduce the likelihood and severity of oral mucositis (OM), which is swelling and irritation inside the mouth. The device is prescription only and intended for adult patients. OM is a common, debilitating complication of cancer treatment. The device was granted a Breakthrough Device designation.

• COVID-19 testing updates:
• As of today, 436 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 299 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
   
• The FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1132 revisions to EUA authorizations

Additional Resources:

• FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration