FDA Roundup: April 21, 2023

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Apr 21, 2023, 15:02 ET

SILVER SPRING, Md., April 21, 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 approved the MiniMed 780G System for modifications to the SmartGuard (SG) Technology and for expanding the indications for use to include the Guardian 4 Sensor. The MiniMed 780G system is intended for continuous delivery of basal insulin (background insulin) at selectable rates, and the administration of insulin boluses (a single large dose of medicine) at a selectable amount for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SG technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. Compared to previously approved Medtronic automated insulin dosing systems, the MiniMed 780G System includes the new Advanced Hybrid Closed Loop algorithm as a part of its SG technology, which can issue automatic correction insulin boluses without user input. Additionally, the MiniMed 780G System offers multiple glucose targets as compared to a single glucose target in the MiniMed 670G/770G Systems.
On Thursday, the FDA announced it will reopen the comment period for the draft guidance entitled "Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry," that appeared in the Federal Register on February 23, 2023. The new deadline for comments will be determined when the reopening notice publishes. The FDA is reopening the comment period in response to requests from stakeholders to allow additional time for interested persons to develop and submit comments.
On Thursday, the FDA authorized for marketing the Bateman Bottle Breast Implant Removal System (BIRS), a single-patient, single use suction device used to assist in the removal of one intracapsular ruptured silicone breast implant. This device is not intended for en bloc removal (when the scar tissue capsule and breast implant are removed together as one unit) and is not intended to remove residual silicone or be applied directly to tissue.
On Wednesday, the FDA released new "Feed Your Mind" educational materials to provide science-based information on genetically modified organisms (GMOs). "Feed Your Mind" is an education initiative launched in 2020 to help increase consumer understanding of GMOs and was developed in partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency.
On Wednesday, the FDA cleared the Selux AST System for use with the Selux Gram-Negative Comprehensive Panel through the 510(k) premarket notification pathway. This follows clearance of the system earlier this year for use with the Selux Gram-Positive Comprehensive Panel. The Selux AST System is an in vitro diagnostic test system used for antimicrobial susceptibility testing. This testing is performed to determine whether an organism is susceptible or resistant to an antimicrobial drug to help physicians select the appropriate drug to treat an infection. The Selux AST System allows for simultaneous testing of a larger number of drugs and drug concentrations than previous systems. The two panels also have the ability to expand to incorporate new drugs in the future. Susceptibility testing systems use FDA-recognized cut-off values (referred to as susceptibility test interpretive criteria or breakpoints), to indicate whether the drug is likely to be effective (drug concentrations below the cut-off are likely to be effective, and drug concentrations above the cut-off are not likely to be effective). Since breakpoints can be updated to maintain clinical success of the drug, the Selux AST System was also cleared with a prospective change protocol, allowing the developer to update breakpoints without an additional premarket submission to the FDA. This is the latest example of the FDA's ongoing commitment to advance access to safe and effective antimicrobial susceptibility testing intended to aid healthcare professionals in making more informed decisions for patients.
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 299 molecular tests and sample collection devices, 83 antibody and other immune response tests, 62 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, 29 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
The FDA has authorized 47 antigen tests and seven molecular tests for serial screening programs. The FDA has also authorized 1351 revisions to EUA authorizations.

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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