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The FDA issued an update on adverse events related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implant illness. Read More
The European Commission’s Medical Device Coordination Group announced that a new Eudamed registration module will go into effect on December 1, enabling users to create a unique single registration number (SRN). Read More
In a dramatic policy reversal instigated by President Trump, the FDA will no longer require lab-developed tests (LDTs) for COVID-19 to undergo premarket review, the Department of Health and Human Services (HHS) announced Aug. 19. Read More
When determining whether to issue an EUA for a multi-analyte respiratory panel that includes SARS-CoV-2, the agency said it considers the clearance or approval status of diagnostics for the other analytes on the panel. Read More
A key requirement of the policy is that the facilities must obtain a device manufacturing permit, which will raise the bar for the domestic industry. Read More
Conventional Foley catheters and cutaneous electrodes are the first two types of devices to get their own final guidances under the FDA’s new safety and performance-based pathway for 510(k) marketing clearance. Read More
The European Commission’s Medical Device Coordination Group (MDCG) said notified bodies can make use of Medical Device Single Audit Program (MDSAP) reports for audits under the EU’s medical device and in vitro diagnostics regulations. Read More