New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
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CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Recent Recall a Reminder to Check Which COVID-19 Tests Your Lab Can Use
Celltrion’s recall was labeled by the FDA as Class I, due to the kits possibly being distributed to non-CLIA certified users.
OIG Green Lights Free Genetic Testing Arrangement
The OIG recently issued an Advisory Opinion approving a proposed arrangement involving the offering of free genetic tests.
Labs in Court Weekly Roundup
False and fraudulent claims and billing were the theme in key enforcement actions relating to the health care industry announced last week.
FDA Reorganizes Its Center for Devices and Radiological Health
The changes affect the Office of Product Evaluation and Quality’s Office of In Vitro Diagnostics and Radiological Health.
Get Ready for G2’s New Website
By the end of this month, G2 Intelligence’s website will have a new look and feel, plus simplified site navigation.
Physician Practices See Strong Q1 2022, but Challenges Remain
Recent report shows physician revenues, compensation, and productivity rose in the first quarter of 2022, but so did subsidies and expenses.
New EU IV Diagnostic Regulation Set to Roll Out
The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of so-called Notified Bodies.
New EU IV Diagnostic Regulation Takes Effect on May 26
While the much-delayed IVDR will take effect at the end of the month, it will be rolled out gradually.
Many Medical Device Companies Are Not Ready for Cyberattacks
According to a recent survey of product security experts, despite many saying their companies are ready for hacks, data show otherwise.
Watch Out for Fake COVID-19 Tests, FDA Warns
Agency warns the public to be on the lookout as counterfeit at-home OTC COVID-19 diagnostic tests appear on the US market.
