FDA Warns of Cybersecurity Vulnerabilities in Pacemakers, Blood Glucose Monitors

USA – FDA recognizes three new international medical device software security standards

The US Food and Drug Administration (FDA) has recognized three new standards related to software security on medical devices. The standards address taking a...

USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing

The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...

USA – FDA extends regulatory flexibilities for PMA, HDE modifications

The US Food and Drug Administration (FDA) has published a final guidance that extends its pandemic-era policy of allowing manufacturers to make certain modifications...

USA – FDA revises final guidance on modifying remote monitoring devices

The US Food and Drug Administration (FDA) has updated final guidance on its enforcement policy for remote patient monitoring devices in an effort to...

USA – FDA revises magnetic resonance guidance to reflect updated international standard

The US Food and Drug Administration (FDA) has revised its position on magnetic resonance (MR) with updates to a pair of final guidance documents. One...

USA – FDA’s CDRH releases list of proposed guidances for FY 2024

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has named the guidance documents it plans to publish during Fiscal...
Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

USA – Diversity plan draft guidance on track before year end, FDA official says

The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take...

USA – Convergence: Tips for when to include PCCPs in product submissions

The US Food and Drug Administration (FDA) sees predetermined change control plans (PCCPs) as a way to improve medical device innovation in the country,...

USA – The biggest misconception regulatory professionals have about the FDA 510(k) program, according...

The 510(k) program is the most common pathway through which medical devices make their way to market in the US. For devices that can demonstrate...

USA – FDA updates physiologic closed-loop control final guidance with industry feedback

The US Food and Drug Administration (FDA) has finalized guidance on physiologic closed-loop control (PCLC) technologies that includes several updates requested by medical device...

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