"Our ability to work with innovators to translate discoveries into safe and effective products that can be cleared or approved in a timely way is essential to public heath, as well as the growth of the medical products industry and the jobs it creates.
In terms of time-to-market, an industry-sponsored analysis showed that low-risk 510(k) devices without clinical data – 80% of all devices reviewed each year – came on the market first in the US as often or more often than in the EU. The EU typically approves higher-risk devices faster than the US because, in the EU, manufacturers must demonstrate safety and performance, while in the US the standard for approval is safety and effectiveness.
The FDA has been meeting or exceeding goals agreed to by the FDA and industry under the Medical Device User Fee Amendments (MDUFA) for approximately 95% of the submissions it reviews each year. The FDA completes at least 90% of 510(k) reviews within 90 days. In the few areas where the FDA is not yet meeting its MDUFA goals, the agency’s performance has generally been improving – despite growing device complexity and an increased workload – without a commensurate increase in user fees.
However, average total days for the review of 510(k)s has been increasing since 2005, and has been increasing for pre-market approval applications since 2004, with early indicators of longer review times, such as the average number of cycles to review a 510(k), starting to increase since 2002. The FDA recognises that, if the US is to maintain its leadership role in this area, it must continue to streamline and modernise its processes and procedures to make device approval not just scientifically rigorous, but clear, consistent and predictable without compromising safety.
To best serve patients, the medical device industry and the FDA must have the flexibility to be innovative and entrepreneurial. First, the Center for Devices and Radiological Health (CDRH) must continue making critical improvements to its device programme. Second, the medical device industry and CDRH must work together to ensure that the centre receives high-quality submissions, which contain the information needed to make well-informed and timely decisions. Finally, CDRH must have adequate and stable resources to get the job done right and quickly.
The FDA bears some responsibility for the increase in total time-to-decision, and it has been instituting policy, process and management changes to address this issue. There has also been a prolonged increase in the percentage of 510(k) submissions requiring an additional information letter after the first review cycle. The increasing number of these letters has contributed to the increasing total time from submission to decision.
Some have suggested that the US adopts the medical device regulatory system of the EU. Yet, outside the US, pressure is growing toward greater pre-market scrutiny of medical devices. There are significant differences between the EU and US medical device review systems. In the EU, manufacturers must demonstrate safety and performance, while in the US the standard for approval is safety and effectiveness. In the EU, more than 70 private, non-governmental entities called notified bodies review and approve devices by giving them a CE mark. The EU does not have one centralised regulatory body. Instead, each country can designate an entity as a notified body, yet the decision of one notified body applies to all EU countries.
Because of these factors, it is impossible to track medical device approvals, adverse events or recalls in the EU, since there are few publicly accessible, centralised systems for collecting and monitoring this information. The use of notified bodies has been criticised as encouraging ‘forum shopping’ by sponsors to identify those notified bodies with the most lax operating standards, and the varying levels of expertise among notified bodies has been critiqued.
The FDA continues to explore ways to get medical products to patients with serious and life-threatening diseases or conditions faster, but lowering US approval standards isn’t in the best interest of American patients, our healthcare system or US companies whose success relies on the American public’s confidence in their products."
Read Shuren’s full testimony on this topic at www.fda.gov.uk.