North America
On March 15, 2019, the US Food and Drug Administration (FDA) issued a final guidance document on medical devices using materials derived from animals. This documents intends to help manufacturers establish relevant procedures to lower the overall risk of infection...
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
North America
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the following three categories: Class I, Class II, and...
North America
In recent years, the opioid epidemic has played a dominant role in the United States as opioids continue to be exploited. The National Institute on Drug Abuse states that more than 115 people die from opioid abuse every day. In May 2018, the specialty company US...
Consultant Post
Dealing with FDA deficiency letters doesn’t have to be hard, read on to find out how best to address your deficiencies.
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