Jeff Shuren, Head of the Center for Devices and Radiological Health (CDRH), has announced on the FDA website that the FDA intends to further the development of improved medical devices. With the example of infusion pumps, Shuren explains that these may include safety risks. Infusion pumps rank among the top ten causes for incidents as well as for recalls. In the past 5 years, infusion pumps were recalled 87 times. However, these recalls have not led to the development of a new generation of these devices, says Shuren. At best, short-term solutions were implemented with no systematic approach to the problem.
In order to speed up the development of safer, more effective infusion pumps, but also of other medical devices, the FDA has developed "tools". Together with the University of Pennsylvania, the FDA has e. g. developed an open-source software for the insulin pumps, which it distributes to the manufacturers so they can use it. Then the manufacturers can also use the open-source software as a benchmark for their own software. The FDA now also offers some kind of software evaluation (diagnostic evaluations) on each development level in order to be able to identify problems at an early stage.
Another approach to improving medical devices is FDA's "unique vantage point". With this term, Shuren hints to the information FDA has on large-part medical devices. This information concerns design and production aspects as well as sometimes clinical data. This confidential information gives the FDA a unique insight that enables them to detect critical aspects of a whole segment of medical devices. This knowledge can then be used to find solution approaches, e. g. by creating them in public workshops. This was also the case with the infusion pumps.
Besides, the FDA initiates meetings with the industry and the public in order to recognise where there is a need for innovation in the medical device sector, also with regard to regulatory inefficiencies. Currently, the FDA is reviewing its "registration procedure" for medical devices (510k) in order to streamline the process and to make it more predictable. This is also meant to incite investors to bring new medical devices on the market.
The contact to partner authorities in other countries is also intended to be strengthened with the objective to find harmonised solutions. A device that injures patients when used in Europe may similarly harm patients if used in the United States, as Shuren puts it.
Then, Shuren makes an interesting statement: "The FDA believes it has to be tough and fair, but the agency also has to be smart". By using this "smart side", the FDA thinks, with its new programme, it plays a more intensive role in the development of better medical devices that can also be placed on the market more quickly.
On balance one can say that the CDRH, as a regulatory authority, does not see its function in the registration and surveillance of medical devices alone, but lately also in its support to the industry in developing medical devices. The aim of this strategy is to facilitate the supply of new and better medical devices to US citizens.
Information on the new CDRH programme can be found here.
On behalf of the European Compliance Academy (ECA)