as submitted to the FDA on September 23, 2011
RE: Docket No. FDA-2011-N-0556[Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report: “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years”; Request for Comments]
On behalf of the Arizona BioIndustry Association (AZBIO), I appreciate the opportunity to submit comments to the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) on the Institute of Medicine’s (IOM’s) report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years” (Docket No. FDA-2011-N-0556).
AZBio is comprised of member organizations in business, research, government, and other professions involved in biosciences. Our 200 member companies develop technologies that allow patients to lead longer, healthier, and more productive lives. The medical technology industry has over 90,000 jobs in Arizona, and is an important contributor to our economy. From 2002 until today, jobs in Arizona’s bioscience industry have grown 32%, the number of bioscience and related firms including research, manufacturing, testing, medical labs, and healthcare delivery systems have grown 28% and research partnerships with the National Institutes for Heath have increased 65%. Arizona bioscience organizations now generate $21 Billion in annual revenues and $765 Million in state and local taxes. While a handful of our member companies are large corporations and institutions, 93 percent of our members are small businesses led by local entrepreneurs. It is these small businesses that present our future as we continue to grow in the creation of new innovations and new jobs.
At AZBio, we believe that the 510(k) process is an important component of FDA’s premarket review and clearance of low- to moderate- risk medical devices. The 510(k) process is a key ingredient in medical progress and can be further strengthened to support innovation, while ensuring that patients have
timely access to safe and effective technologies.
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 ack nowledges 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. Those include:
Recommendation: Enhancing the training, professional development, and knowledge-sharing among reviewers and managers
Benefit: Training increases worker productivity. Just a 2-percent increase in productivity has been shown to net a 100 percent return on investment in training (source: “The 2001 Global Training and Certification Study,” CompTIA and Prometric). Motorola calculated that every dollar spent on training yields an approximate 30 percent gain in productivity within a three-year period. Motorola also used
training to reduce costs by over $3 billion and increase profits by 47 percent (source: Tim Lane et al., “Learning to Succeed in Business with Information Technology,” Motorola). This increased efficiency can lead to faster turnaround times, less cost to both the agency and the submitting companies, and the increased benefit of getting lifesaving and life enhancing products to market faster.
Developing more definitive device-specific guidance documents that ensure consistency of device reviews
Benefit: Nothing is more wasteful for both the agency and the innovator that having to prepare and review multiple submissions. The more specific our guidance documents are, the less likely that we will need to submit multiple times. For small businesses in particular, gray areas that lead to resubmissions can make the difference between success and failure or between survival and expansion of their workforce.
Simplifying and improving the “de novo” process for moderate-risk products that are too novel to meet the normal 510(k) “substantial equivalence” test but do not warrant review through the Premarket Approval (PMA) process;
Benefit: Moving from “new and improved” to true innovation. Our global advantage as a nation is true innovation. The current substantial equivalence process is a great cost and time saver, but also encourages companies to be less innovative so that they can take a shorter, faster, and less innovative route. To spur innovation, there is a true advantage to expanding the de novo process and guidelines to open them up to a wider range of moderate-risk products. This is especially important for our small
businesses as their resources are severely limited in these economic times. The ability to bring more new products to market faster leads to more investment, more jobs and a greater competitive advantage for our country. We need to keep these innovations and the jobs they create right here at home and not send them overseas as this New York Time article portrays. (Medical Treatment, Out of Reach, Andrew Pollack, The New York Times, February 9, 2011) http://www.nytimes.com/2011/02/10/business/10device.html
Applying special, clearly-defined requirements to a small subset of devices where enhanced premarket and postmarket requirements are appropriate to demonstrate safety and effectiveness.
Benefit: As previously stated, clarity in guidelines and requirements saves both time and money for everyone and keeps our nation competitive. Clear definitions and cost saving measures that still maintain the reasonable and prudent risk levels to safeguard the public are the best gift we can give our entrepreneurs and innovators. Gray areas are the enemy as they lead to delays and uncertainty that small business owners cannot afford.
Again, AZBio appreciates the opportunity to comment on IOM’s 510(k) report and comments FDA’s continued commitment to an open, public dialogue on these issues. Thank you for consideration of these comments.
President and CEO
AZBio, The Arizona Bioindustry Association
1475 N. Scottsdale Road, Suite 200 | Scottsdale, AZ 85257