Remove Electronics Remove Government Remove Manufacturing Remove Patients
article thumbnail

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

article thumbnail

Are You Recall Ready? FDA Expects You to Be

FDA Law

Almost all recalls are conducted on a voluntary basis by the manufacturer. In recognition that hard copy communications are slower and more cumbersome, FDA recommends that firms use electronic communications, as they lay out the details of the electronic means here , to notify the public about recalls.