Regulations

FDA said it enacted this measure because there were performance concerns with the accuracy of the test.

FDA cited Allergan for failure to comply with post-approval study requirements. The agency also cited Ideal Implant for failures relating to quality system and medical device reporting regulations.

The new Medicines and Medical Devices Bill introduces new patient safety measures, widens prescribing of low-risk medicines, and prepares the NHS for personalized treatment, cementing the UK’s role as a pioneering center for healthcare innovation...

Experts speaking at MD&M West offered strategies for preparing for the European Union's Medical Device Regulation.

An industry expert discusses why developing new solutions, IoT, and blockchain must be important components of a medtech company’s strategic planning.

The new Boston Scientific device is designed to provide a durable, "natural-feeling" erection, and is easier for surgeons to implant.

Here’s some of the stock language typically included in FDA Warning Letters.