USA – FDA official discusses use cases, limits for device PCCPs
While predetermined change control plans (PCCPs) may not typically be appropriate for changes to a device’s indications for use, they can be useful for...
usa – Industry calls for changes in FDA’s RWE guidance for devices
Medical device industry groups say the US Food and Drug Administration’s (FDA) draft guidance using real-world evidence (RWE) to support regulatory decision making for...
USA – FDA official warns device makers over supply chain risks
Manufacturers and healthcare providers are reverting to old business practices that could jeopardize medical device supply chains in the event of another public health...
USA – FDA proposes down-classifying most high-risk IVDs
The US Food and Drug Administration (FDA) intends to reclassify most high-risk in-vitro diagnostics (IVDs) from class III devices to class II moderate-risk devices....
USA – FDA updates guidance on remote regulatory assessments
The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...
USA – FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They...
Physicians heavily rely on laboratory tests to make critical decisions about their patients’ care—roughly 70% of healthcare decisions depend on laboratory test results according...
USA – FDA proposes guidance on orthopedic product coatings
The US Food and Drug Administration (FDA) wants orthopedic device sponsors to provide additional data in their premarket application if their product has a...
USA – FDA updates sterilization category to encourage vaporized hydrogen peroxide use
The US Food and Drug Administration (FDA) has recategorized vaporized hydrogen peroxide (VHP) as a sterilization agent, signaling to medical device manufacturers that it...
Canada – Amendments to the Medical Devices Regulations to address future public health emergencies
On February 22, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use...
USA – FDA updates third party 510(k) guidance
The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review...
