Orthopaedic surgeon available to speak about physician roles in the monitoring of medical device recalls; factors that contribute to the highest quality of patient care

ROSEMONT, Ill. (October 3, 2022)—When a medical device fails to function as originally intended it can jeopardize patient safety and confidence. One important role of the FDA is to continue monitoring devices after approval to mitigate the detrimental effects of…

Seafood Products Made From Cells Should be Labeled Cell-Based

Companies seeking to commercialize seafood products made from the cells of fish or shellfish should use the term “cell-based” on product labels, according to a Rutgers study – the first of its kind – in the Journal of Food Science. Both the U.S. Food and Drug Administration and U.S. Department of Agriculture require food products to have a “common or usual name” on their labels so consumers can make informed choices about what they’re purchasing.

Redesigning Hand Sanitizer and Donating 7,000 Gallons to Fight Covid-19

Notice how hand sanitizer has made a comeback? It was running out, but this charitable initiative helped revive it by tapping into ethyl alcohol and FDA approval.

The Need for FDA to Regulate Poorly Performing Commercial COVID-19 Tests Should Not Hinder Laboratory-Developed Tests

In the wake of FDA’s decision to loosen its emergency use authorization criteria for COVID-19 tests, reports have now been surfacing about unreliable commercial COVID-19 serological tests. While this is a major concern, AACC wants to emphasize that these problematic commercial tests are not the same as laboratory-developed tests–and that we still strongly support FDA’s decision to step back from regulating lab-developed tests for COVID-19.

AACC Urges Congress to Ensure That All COVID-19 Tests Are Covered by Insurance Now That FDA Has Released Guidance That Will Expand Testing Access

On March 16, FDA updated its guidance on COVID-19 testing to allow clinical labs to create and perform COVID-19 tests without pursuing FDA emergency use authorization (EUA). AACC commends this decision, which will help speed the expansion of COVID-19 testing at this crucial time. However, the association remains concerned that the Families First Coronavirus Response Act does not provide coverage for COVID-19 tests unless the tests are performed under an EUA. AACC urges Congress to rectify this problem before passing the bill so that all patients will have access to coronavirus testing.

New Legislation Would Jeopardize Patient Access to Medical Tests Across the Board by Restricting Policy that Removed Barriers to Coronavirus Testing

On March 5, U.S. House and Senate lawmakers introduced the VALID Act, which would give the Food and Drug Administration (FDA) new, expansive powers to regulate laboratory developed tests—tests that are already regulated by the Centers for Medicare and Medicaid Services (CMS) and are subject to stringent personnel, quality control, and proficiency testing requirements. This bill promotes duplicative, costly federal regulations for clinical laboratories that will result in decreased patient access to essential medical tests. AACC urges Congress not to act on this bill until its impact on healthcare can be thoroughly evaluated.

AACC Statement on New FDA Guidance That Allows Certified Labs to Perform Coronavirus Testing

AACC thanks the FDA for being responsive to the concerns of the clinical laboratory community and amending the coronavirus guidance to allow CMS-certified labs to develop and implement new tests for coronavirus prior to FDA approval.