Brits Say “No Thanks” to U.S. PMA Process

The British say “no thanks” to a U.S. style premarket approval (PMA) process.

The tension between the FDA’s two goals of “promoting” and “protecting” public health leans heavily on the “protecting” side with a vigorous PMA process. Once devices are approved, a modest level of post approval surveillance is required. Some U.S. patient advocate groups don’t believe the U.S. system is vigorous enough.

In Europe the opposite approach is used. “Promoting” public health is heavily desired with a modest approval process, but a more vigorous post approval surveillance programs is in place to monitor how those devices are behaving in patients. Hence, national registries in Europe and elsewhere around the world are often the early warning systems of device failures. The metal-on-metal hip failure rates were first noted in overseas registries.

We’ve spoken confidentially to some FDA staffers who believe the European model makes guinea pigs out of patients. The FDA’s device chief, Jeff Shuren, M.D., got into hot water with his European counterparts a couple of years ago when discussing this different approach.

EU Regulatory Overhaul

The European Commission is proposing to overhaul the EU’s medical device regulations. The Brits, through the government’s Medical and Healthcare Products Regulatory Agency (MHRA) put out a recent report saying they don’t need a U.S. style premarket process.

According to our contacts at BSI Assurance UK Limited, a leading notified body, the MHRA response demonstrates clearly the UK view that the proposals to include a centrally controlled scrutiny system and a strong level of oversight of notified bodies that review and approve high risk medical devices, “are enough to regulate properly medical devices and restore trust in the UK and EU healthcare systems.”

PMA Delays Threaten Safety

“The report to the House of Commons challenges the lack of evidence to support the statement that a central government premarket approval such as in USA would bring improved safety to patients. It also explains that central government premarket approval causes delays in patient access to medical implants and is, in itself, a threat to patient safety.”

“The UK Government considers that the principles of the European system are sound and states that adopting a more centralised regulatory framework, as exists for medical devices in the United States, would not be desirable. Instead it is important to address the weaknesses in the European system, by building on the current regulatory framework. This way the UK is confident to be able to deliver a system that ensures a high-level of patient safety from pre-market assessment of devices by notified bodies to common European standards to rigorous post-market surveillance by manufacturers and competent authorities, ” concluded a statement from Dr. Ir. Gert Bos, head of BSI’s regulatory and clinical affairs, medical devices.