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Speaking Of Medtech, Ep. 3: FDA Quality System Regulation Harmonization
On this episode of Speaking Of Medtech we talk about arguably one of the biggest regulatory changes to come down the pike in decades: the ongoing harmonization of the US FDA’s QSR, which is going to broadly change the way the agency handles medical device quality oversight.
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The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
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Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
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The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
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Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
More from Policy & Regulation
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
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The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?
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Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.