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FDA delays UDI database enforcement for low-risk devices

On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a requirement that manufacturers of...more

8/5/2022 / Final Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry , Product Labels , Unique Device Identifiers

FDA Finalizes De Novo Evaluation Guidance and Issues Associated Refuse to Accept Checklist

On October 30, 2017, the Food and Drug Administration (FDA or the Agency) released its final De Novo request guidance document entitled, De Novo Classification Process (Evaluation of Automatic Class III Designation) (Final...more

11/17/2017 / De Novo Standard of Review , Final Guidance , Food and Drug Administration (FDA) , Medical Device User Fee Program (MDUFA IV) , Medical Devices , User Fees

Is it a drug, device, biologic, or combination product? FDA issues final guidance on classification

On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more

10/23/2017 / Biologics , Classifications of Goods , Device Classification , FDA Approval , Final Guidance , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Standards

Working Together: FDA Releases Final Guidance on Interoperability

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

10/3/2017 / Cybersecurity , Final Guidance , Food and Drug Administration (FDA) , Labeling , Medical Devices , Popular , Regulatory Oversight , Risk Management , Safety Standards

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