Regulation of Medical Devices
Supplementing its non-regulatory activities with respect to medical devices, FDA is also taking steps to reduce the burdens imposed by its medical device regulations. First, FDA is revising its adverse events reporting requirements to convert to a paperless, electronic reporting system. This will help FDA more quickly review these reports and identify emerging public health issues.
Second, FDA intends to maintain its ongoing review of classifications of medical devices based on risks to determine whether a particular device can be reclassified to a lower level. FDA anticipates that this ongoing review process will reduce burdens on industry, but maintain the safety and efficacy of the products.
Finally, FDA intends to allow validated symbols in certain device labeling without the need for accompanying English text. The agency believes this change will reduce the burden of having unique labeling requirements for the U.S. market and achieve consistency with labeling requirements for international markets.
FDA believes that reducing the burdens imposed by medical device regulations will result in a general costs savings across the board. Electronic submissions for adverse event reporting will eliminate the need for paper copies and will reduce processing time. Reduced processing time will increase efficiencies. The regulated industry will benefit by eliminating the cost of paper submissions including delivery costs and the consumer will benefit because FDA will be able to receive, process, and react to submissions of adverse events more quickly and efficiently leading to increased public health benefits.
Reducing the level of classification where appropriate, while still maintaining safety and effectiveness of certain products will also lower costs. Industry will benefit because the costs for submissions required to reach the market will be reduced and the consumer will benefit because safe and effective products will arrive in the market place more efficiently.