incremental improvements in technology as a result of small changes in the iterative design process, increase treatment options for individual patients and their disease phenotypes, and contribute to clinical quality improvement through the use of performance information on improved devices. Thus, the process promotes innovation in support of public health.

Incremental improvements in technology translate into substantial changes for patients, he said. In total knee arthoplasty, for example, there were failures from polyethylene wear due to oxidative degeneration. A Harvard innovation added an antioxidant that stabilizes free radicals and reduces the potential for oxidation. The change was cleared through the 510(k) process and has contributed to the extended life of many total knee implants. For patients, that means fewer revision surgeries and improved quality of life.

With flexibility and regulation comes responsibility. FDA must continually evaluate its performance in assessing risks and benefits and in determining safety and effectiveness. The question should be not whether but how changes should be implemented to maintain FDA’s performance while expanding it to accommodate greater volumes of 510(k) submissions. Administrative changes are necessary to ensure that decision-making authority resides with the most qualified people and to prevent interference in the review process that is not grounded in scientific inquiry.

Medical Device Manufacturers

Industry Associations

The Medical Device Manufacturers Association (MDMA) represents more than 200 primarily small to middle-size medical device companies. The companies drive innovation and develop the technologies that improve patient care in the long term and reduce the cost of care. A representative of MDMA said that over 100,000 devices have been cleared via the 510(k) process since 1976, and there have been relatively few adverse events. Although some patients have had suboptimal outcomes, which are not to be overlooked, there is a lack of qualitative and quantitative data to demonstrate a systemic failure. There will always be outliers, but in the absence of hard evidence that suggests a systemic failure, he urged the committee to be cautious in suggesting broad sweeping changes in the system as a whole. He suggested that the FDA recall database would be one repository that could be part of a systematic review. If the data suggest systemic failures or isolated pockets of products that need additional scrutiny, MDMA is willing to address them and to make sure that the appropriate special controls or remedies are in place. But it is necessary for the data to demonstrate that

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