Importance of reviewing warning letters
By reviewing relevant U.S. Food and Drug Administration (FDA) warning letters, manufacturers can better understand areas of frequent concern related to quality management systems (QMS) and regulatory affairs. This can allow companies to focus on areas of highest risk as they continually assess and improve their internal procedures and processes. It also helps a company better understand significant concerns from the FDA.
Warning letters in 2024
The FDA’s Center for Devices and Radiological Health (CDRH) issued 529 warning letters in 2024,[1] most related to drugs, tobacco products or food products. Of those, 8% (44)[2] were issued for medical devices. Most warning letters include multiple issues. Please see our previous blog on 2024 warning letters for additional details.
US FDA Warning Letters: Considerations for LDTs including Timelines | Emergo by UL
US FDA Warning Letters: Considerations for LDTs including Timelines
Reviewing relevant U.S. Food and Drug Administration (FDA) warning letters can help manufacturers better understand areas of frequent concern related to quality management systems (QMS) and regulatory affairs. This allows companies to focus on areas of hig
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