AZBio Comments on the FDA 510K

 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)

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.


Joan Koerber-Walker

President and CEO

AZBio, The Arizona Bioindustry Association

1475 N. Scottsdale Road, Suite 200 | Scottsdale, AZ 85257

Posted in Advocacy and Regulations, Government Affairs Blog.