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FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests Share  Post Linkedin Email Print For Immediate Release:September 29, 2023 Español Today, the U.S. Food and Drug Administration announced a proposed rule regarding laboratory developed tests, or LDTs, which play an important role in healthcare.

Title: Navigating Medical Device Cybersecurity: A Guide to Compliance with Section 524B Summary: The recent passage of Section 524B under the Consolidated Appropriations Act, 2023, signifies a crucial step in enhancing medical device cybersecurity. Effective from March 29, 2023, this legislation mandates that medical device manufacturers comply with specific cybersecurity standards. Failure to meet these requirements by October 1, 2023, could lead to the U.S. Food and Drug Administration (FDA) rejecting premarket submissions.

Note: The following listings are prohibited for any seller not authorized to sell Rx medical devices through the Professional Health Care Program.

Summary: The FDA has initiated an investigation into the Anterior Growth Guidance Appliance (AGGA) after a joint investigation by KHN and CBS News reported allegations of severe harm caused to patients. The inventor, Dr. Steve Galella, claimed the device was never submitted to the FDA, and the agency is now assessing its regulatory authority. Former FDA officials believe regulatory action, possibly including a warning letter and device custody, may be taken.

Title: “Unraveling Clinician Burnout: A Closer Look at Global Trends and Unprecedented Challenges” In a recent Forbes article, Dr. Robert Pearl explores the escalating crisis of clinician burnout in the U.S. Despite numerous efforts to address the issue, the problem persists, prompting a call for a diagnostic reevaluation akin to reevaluating a patient’s treatment plan.

Title: The Impact of Diagnostic Errors in the US Healthcare System A recent report sheds light on the significant repercussions of diagnostic errors in the United States, revealing that approximately 371,000 people die and 424,000 sustain permanent disabilities annually due to misdiagnosis-related harms. The study, led by Dr.

Title: AHRQ Introduces Measure Dx to Address Diagnostic Errors and Improve Patient Care Summary:The Agency for Healthcare Research and Quality (AHRQ) is intensifying its commitment to eliminate diagnostic errors with the introduction of Measure Dx, a clinical tool aimed at preventing diagnostic inaccuracies. Despite challenges in the complexity of medical care, diagnostic errors remain prevalent, affecting 1 in 20 adults annually in outpatient settings and leading to an estimated 250,000 errors in U.S. hospitals.

What is the policy? Why does eBay have this policy? Helpful links Medical devices that require a prescription can’t be sold on eBay. Listings for other medical devices must follow our policy. It’s important to check that items can be sold on eBay before they are listed. What is the policy?

Examples of prohibited listings for all sellers The following medical devices are prohibited for sale per FDA regulations: Diabetic test strips that are pre-owned or test strips not authorized for sale in the U.S.

Title: “Understanding CMS Authority to Limit Coverage of FDA-Approved Products: Legal and Policy Considerations” Summary:The article explores the legal framework and policy considerations surrounding the Centers for Medicare & Medicaid Services (CMS) authority to shape coverage of FDA-approved products under Medicare Part B. The CMS, tasked with determining whether therapies are “reasonable and necessary” for coverage among Medicare beneficiaries, faces controversy in exercising this authority.