Arizona Bioindustry Association - Comment

The Arizona Bioindustry Association (AZBio) supports FDA’s position that the 510(k) program should not be eliminated. The 510(k) review process works well and has a strong safety record. The IOM committee itself acknowledges that there is no evidence that the 510(k) process is failing to assure safety and effectiveness. As FDA continues to move forward with its 510(k) implementation plan, AZBio urges FDA to proceed with caution. Significant changes to the program could increase companies’ regulatory burden and lead to patient delays in accessing safe and effective technologies. Any increase in the regulatory burden would also invoke the Regulatory Flexibility Act (RFA) which would cause even more delays, costs and uncertainty to the 510K process. However, AZBio also believes that several of the proposed changes to the 510(k) process have merit and, if implemented, would result in a more predictable and consistent process that supports device innovation while continuing to ensure safety and efficacy and support the growth of small and emerging businesses that are protected under the Regulatory Flexibility Act (RFA). For more details on the proposed changes, their impact and benefits, please see the attached letter from the Arizona BioIndustry Association.