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ISO 20417

MedTech Current publications and recall entries tagged ISO 20417.

Regulatory Intelligence

FDA Publishes Recognition List 066: Check Standard Versions, Recognition Scope, and DoC Transition Dates

FDA has formally published Recognition List 066 in the Federal Register, covering additions, replacements, and revisions to recognized consensus standards used in medical-device premarket submissions. Manufacturers should review not only the new standard editions but also FDA recognition numbers, complete versus partial recognition, and transition deadlines for declarations of conformity.