Oct 4, 2023
CDRH
This article talks about USFDA Medical Device Approval Timeline as per their Classification. Table of Contents The process of getting FDA approval for a medical device can be lengthy and complex.The time it takes for a medical device to receive FDA approval can vary...
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Oct 4, 2023
CDRH
This blog post will provide an overview of the GUDID, its purpose, how it works, and its impact on the healthcare industry. Table of Contents The FDA’s Global Unique Device Identification (UDI) Database is a pioneering initiative that has revolutionized the...
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Mar 14, 2021
FDA
The Center for Devices and Radiological Health (CDRH), a division of the Food and Drug Administration (FDA), has published detailed information about the Patient Science and Engagement Program – the new approach intended to improve the engagement of patients in...
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Jun 5, 2020
Canada
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, issued a compliance program describing the inspections related to CDER-led or CDRH-led combination products. The document provides the requirements for different...
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May 8, 2020
FDA
The Center for Devices and Radiological Health (CDRH), the unit of the Food and Drug Administration (FDA) responsible for medical devices regulation, issued guidance describing how medical device manufacturers should notify CDRH of a permanent discontinuance or...
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