Product recalls and compliance issues affect all sectors, but some industries face more significant challenges than others. Medical device manufacturers, for example, should know the legal consequences of product recall non-compliance. These consequences include fines and enforcement action levied by the FDA for not responding to safety notices. As a medical device manufacturer, you might not [...]
The United States Food and Drug Administration has provided expedited priority review for certain medical devices since 1994. The move is meant to shorten the lead time it takes for patients to access breakthrough devices. However, new research published in JAMA Internal Medicine seems to draw correlations between shorter review times and increased chances [...]
Researching and developing a medical breakthrough is easy when you compare it to the process of getting approval from the U.S. Food and Drug Administration. The FDA had a long list of requirements to reach and maintain compliance, and it’s not a cheap or easy process. Failing to do so, however, can cost your [...]
In simpler times, the U.S. Food and Drug Administration (FDA) mostly concerned themselves with food and drugs. These days, the proliferation of medical devices means the agency needs a robust technology department that includes both hardware and software. These medical devices, like anything else connected to the internet, come with cybersecurity concerns. HIPAA Journal [...]