It is a critical time for reform of medical device regulation globally. In Europe, the European Commission is reviewing its process of medical device regulation—one that was established over 20 years ago and has not kept up with technological advances.
In order to conduct rigorous reviews of medical devices and ensure their safety and efficacy prior to approval and in the post-marketing period, it is critical that regulatory agencies have sufficient funding and political backing. The FDA commissioner has stated that the FDA's “resources are outstripped by our responsibilities…there is a continuing need for expansion of investment” 
. Additionally, the safest and best way to speed review times—as industry prefers because it would reduce costs associated with developing new technologies—is to increase funding for FDA to allow more review staff. The Makower Report, based on a survey of device companies, found frustration with changes in key personnel at the FDA during product evaluation and unpredictability with the agency 
. Unfortunately, user fees paid by the device industry constitute about one-sixth of the device budget and make the agency financially dependent on the device industry that it is supposed to be regulating 
. With more resources and financial independence, the FDA would be more likely to retain key personnel and allow them to work closely with companies during the process.
In addition, the FDA requires sufficient political support to fulfill its mission. Unfortunately, instead of recognizing that the FDA is limited in its regulatory ability due to underfunding, some members of Congress—using justification from industry-sponsored studies whose validity has been critiqued 
—state that the FDA should be penalized for conducting slow device reviews. At a United States House Energy & Commerce meeting last year, Representative Michael Burgess (R-TX), a physician, stated, “It is up to us to provide the funding. It is up to the administrator at the FDA to get the job done with the tools at hand. Why would you pay more for what you are getting? We want more of this? How far away from desirable do we care to be?” 
. Certainly in the US$350 billion global market for medical devices, additional funding can be obtained for device regulation.
In reforming the device approval process, it is important for all stakeholders in the process to come together. A superb example was the European Society of Cardiology's recent release of a consensus document that suggests several reforms for the outdated European medical device approval process. These include creating a single, coordinated European system to oversee medical device approval and developing product standards 
. Currently, the European Union's device approval and recall system is said to be limited in usefulness as it lacks transparency and there are few publicly available data 
. A similar problem has been found with the FDA review process 
. If regulatory agencies are not adequately equipped to assess devices—and they currently are not—the data should at least be made publicly available to allow for ongoing assessment of devices. Going forward, adequate funding and political backing are essential so that global agencies such as the FDA and EU Notified Bodies can adequately assess medical device safety and efficacy prior to approval and monitor them in the post-marketing period.