FDA Roundup: March 17, 2023

SILVER SPRING, Md., March 17, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• Today, the FDA issued an emergency use authorization (EUA) for the Cue Mpox (Monkeypox) Molecular Test for use in a point-of-care (POC) setting. The Cue Mpox (Monkeypox) Molecular Test is molecular-based test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of monkeypox by their healthcare provider. This EUA is the latest example of the FDA’s ongoing commitment to advance greater consumer access to tests for infectious diseases.
• On Thursday, the FDA updated the webpage Medical Device Shortages During the COVID-19 Public Health Emergency to reflect changes to expected shortage durations for:
  • Radiological devices
  • General plastic surgery devices
  • Cardiac diagnostic, and monitoring products
  • General ICU/ hospital products and
  • Specimen collection - testing supplies and equipment and
  • Ventilators - ventilation-related products.

The FDA also added several medical devices to the device discontinuance list including:

• • One trade name of surgical masks (product code FXX)
  • One trade name of surgical apparel (product code LYU)
  • One trade name of surgical caps (product code FYF)
  • Multiple trade names of portable oxygen generators (product code CAW).

The FDA continues to work with federal partners and other supply chain stakeholders to help mitigate and prevent shortages of medical devices. The FDA will continue to monitor the supply chain and update the device shortage list and device discontinuance list as new information becomes available.

• On Wednesday, the FDA announced a final guidance, Definitions of Suspect Product and Illegitimate Product for Verification Obligations, as part of the agency’s implementation of the Drug Supply Chain Security Act (DSCSA). The guidance clarifies FDA’s interpretation of specific terms used in the definitions of “suspect product” and “illegitimate product” to assist trading partners in meeting verification obligations (including notification). The specific terms discussed in the guidance are counterfeit, diverted, stolen, fraudulent transaction, and unfit for distribution. This guidance replaces the draft guidance of the same name.

  The DSCSA establishes requirements for product tracing, verification, and product identification for certain drug products that are distributed in the U.S. to enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. These requirements add safeguards to improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

• On Wednesday, the FDA issued a draft guidance, Development of Local Anesthetic Drug Products with Prolonged Duration of Effect, to assist sponsors that are developing local anesthetic drug products to produce postoperative pain relief for a prolonged duration. The administration of these drug products has been used to reduce or eliminate the pain associated with surgical procedures, such as inguinal hernia repair or total knee arthroplasty. Many of the local anesthetic drug products currently available are only effective for several hours. This guidance focuses on local anesthetic drug products that prolong the duration to a period of days rather than hours.

  This guidance is part of FDA’s efforts to reduce or eliminate the use of opioid analgesic drug products. The agency continues to explore ways to use our current authorities to improve the availability of non-addictive treatments for pain. Comments and suggestions regarding this draft guidance should be submitted within 60 days of publication in the Federal Register of the notice of availability of the draft guidance.

• On Wednesday, the FDA issued a warning letter to a leading manufacturer of endoscopes, Olympus Medical Systems Corporation, following an inspection of an additional facility in Tokyo, Japan that manufactures endoscopes and endoscope accessories. This is the latest step in the Center’s extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes, which are medically-necessary devices used in the diagnosis of certain conditions, including some cancers of the digestive tract and associated structures. This warning letter follows previous warning letters issued to the firm and one of its subsidiaries on January 10, 2023, and describes additional violations of the Federal Food, Drug, and Cosmetic (FD&C) Act at another Olympus manufacturing facility.

  “Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA’s Quality Systems requirements are essential to protecting public health.”

  The recent warning letter cites numerous violations of the FD&C Act, including failure to evaluate user reports of adverse events (Complaint Handling) and, when necessary, report the event to the FDA (Medical Device Reporting). Additional violations cite Olympus’ failure to correct and prevent recurrence of quality problems and verify and validate that its preventive, as well as corrective actions are effective (Corrective and Preventive Actions). The FDA will continue to ensure that Olympus fully addresses the violations described in the warning letters.

• COVID-19 testing updates:
  • As of today, 445 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and five for molecular OTC at-home tests.
  • The FDA has authorized 45 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1298 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.

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SOURCE U.S. Food and Drug Administration