FDA Reclassifies Two Skin Cancer Diagnostic Devices
The Food and Drug Administration (FDA) issued a final order on March 25, 2026 reclassifying two types of skin-cancer-related…
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Key FDA Changes MedTech Manufacturers Need to Know
The FDA has issued an update for MedTech Manufacturers to its List of FDA-Recognized Consensus Standards, published as …
FDA Guidance on General Wellness: Policy for Low-Risk Devices
The FDA released a revised final version of its guidance, General Wellness: Policy for Low Risk Devices, on January 6, 2026.
FDA Final Guidance: Clinical Decision Support Software
The U.S. Food and Drug Administration (FDA) released an updated final guidance document titled “…
FDA Guidance on Cuffless Blood Pressure Measuring Devices
The FDA officially released the draft guidance “Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing…
FDA Issues Updated Final eCopy Submission Guidance
The FDA issued an updated final guidance document titled “eCopy Program for Medical Device Submissions” on…
FDA Issues Technical Amendments to Align with QMSR
The U.S. Food and Drug Administration (FDA) has published a final rule implementing technical amendments across…
FDA Regulatory Inspections and Audits
Preparing for regulatory authority (e.g. US FDA) inspections and Notified Body audits (for CE Marking) is a critical, ongoing process…
FDA Guidance on PCCP AI-Enabled Medical Devices
On August 18, 2025, the FDA issued final guidance for industry on how to include a…
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