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...
Coronavirus delays many FDA foreign inspections

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The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...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...
Special 510(k)s: CDRH’s Proposed Program Expansion Draws Mixed Reactions

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The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review...

USA – Experts discuss red flags that can trigger legal action against drug and...

Legal observers discussed some of the red flags that can trigger legal actions against healthcare product manufacturers, as well as some of the lessons...

USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR...

The Department of Health and Human Services (HHS) recently published the fall 2023 unified agenda for the US Food and Drug Administration (FDA) that...

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