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Recently the U.S. Food and Drug Administration (FDA) regulatory mechanism by which most orthopedic implants reach the U.S. market, known as the 510(k) premarket notification process (hereafter, the 510(k) process), has been questioned. Some critics believe that devices reaching consumers through this process are not thoroughly evaluated, consequently creating a risk to patients. In response, the United States Food and Drug Administration (FDA) has initiated a review of the 510(k) process. Though Biomet believes the existing 510(k) process provides a strong regulatory framework that has made advanced technologies available to improve patient care, we look forward to being part of the discussion initiated by FDA. Biomet welcomes the opportunity to work with the FDA to enhance the regulatory process so that state-of-the-art products will continue to reach surgeons, and their patients, in a timely manner.

How Does FDA Evaluate New Products?

In the United States, medical devices are regulated by the FDA and are divided into three classifications, based on risk. The classification of any medical device determines the degree of scrutiny and information the FDA demands before allowing the device to be marketed. Class I devices (e.g., bandages and dental floss) are of low risk to the public. Class II devices are of moderate risk, and include most devices used for orthopedic surgery. Class III devices carry the highest level of risk to the patient and must follow the most stringent process in order to reach the market.

The 510(k) Process for Class II (moderate risk) devices

Manufacturers of Class II devices are required to file a 510(k) Premarket Notification with the FDA, in which the manufacturer must show that the device is "substantially equivalent" to a legally marketed device with the same intended use. The 510(k) process has been a reasonably flexible process that allows FDA to request and review substantial preclinical and animal data. At its discretion, FDA may also require clinical data for Class II devices. When FDA is satisfied that the device meets the substantial equivalence requirement, FDA will clear the device and allow it to be marketed.

Ninety percent of the medical devices on the market today – over 120,000 devices -- were cleared through the 510(k) process¹.

Why Does FDA Want to Change the Process?

Critics of the 510(k) process, including some within the FDA, have stated that the 510(k) process is not sufficiently stringent. In response, FDA launched an internal review of the 510(k) program, and has also asked the Institute of Medicine (IoM) to independently review the program. While a final report from the IoM is not expected until March of 2011, FDA anticipates implementing changes resulting from its own internal review by September 30 of this year. Biomet has participated in the public meetings for both reviews, and looks forward to working with both FDA and IoM as these reviews move forward.

Interestingly, just last year, the Government Accountability Office (GAO) concluded its own investigation of the 510(k) process. In its report, the GAO did not criticize the process in general as being ineffective or lax. Instead, the report focused on a small sub-set of "pre-amendment" Class III devices which had not yet been classified as Congress intended in 1976. GAO noted that Class III devices usually require a more involved process than the 510(k), known as the Pre-Market Approval (PMA) notification, and recommended that FDA complete its work of either reclassifying the devices in question from Class III to Class II or requiring that the devices undergo the PMA process. The report was in no way an indictment of the 510(k) process.

Strengths of the 510(k) Process

It is a misconception that the FDA allows a device to reach the public without investing substantial time reviewing the science and technology about the device in question. Kate Cook, Associate Director for Regulations and Policy at FDA's Center for Devices and Radiological Health (CDRH), recently stated, "This is not a rubber stamp or a fast-track approval." Cook indicated that if FDA classifies an implant as Class II, it means FDA knows a lot about the device and its history².

As noted, FDA may require clinical data prior to clearance of Class II devices, at its discretion. In this fashion, FDA already has the authority it needs to balance risk and benefit on a case-by-case basis.

Additionally, FDA has numerous checks and balances in place to ensure the public's welfare. In order to comply with Current Good Manufacturing Practices for FDA-regulated products, manufacturers of Class II and Class III devices must conduct a risk analysis for the proposed device and have it on file to be produced at any FDA inspection of their facilities. In addition, FDA requires manufacturers to report complaints of device malfunctions and any adverse events associated with medical devices. In this way, problems can be detected and remedied quickly.

Janet Trunzo, Executive Vice President for Technology and Regulatory Affairs for the Advanced Medical Technology Association (AdvaMed), stated the case well:

"The 510(k) process provides strong protections to American patients and promotes medical innovation. It gives FDA the flexibility it needs to ensure the safety and effectiveness of incremental changes made to low- and moderate-risk medical devices whose risks are well understood from experience with similar devices. While the basic structure of the 510(k) process works very well and has evolved over time to better meet the needs of American patients, we recognize that there is no process that cannot be improved."³

Impact on the Public

As the population ages, the availability of innovative devices will become even more crucial to treat the growing number of medical disorders. Conversely, the number of FDA's 510(k) clearances has gone down in the last decade, from 4,133 in 1998 to 3,041 in 2008.⁴

The orthopedic industry has a rich history of developing innovative devices designed to relieve pain and restore mobility.^5,6 Indeed, bone and joint disorders are the single largest cause of disability⁷ in the United States, and drained $339 billion⁸ in productivity from the U.S. economy in 2004. The 510(k) process has succeeded in delivering needed technology to patients in a timely fashion.

Total joint replacement implants provide a good example of how incremental product improvement benefits patients. From 1997-2007, continuous improvements in total joint replacement implants have delivered enhanced technology and improved durability, contributing to a reduction in the revision burden in the United States.⁹ Concurrently, the proportion of total joint recipients under the age of 65 has increased dramatically. It is inconceivable that an increase in younger, more active patients could coincide with a reduction in revision burden without concurrent improvement in the durability of available implants. Through continuous improvement, joint replacement has become more predictable and durable. A more stringent 510(k) process would slow down the rate at which these improvements are made available to patients.

Conclusion

Biomet supports the current 510(k) program. We believe that it provides an excellent regulatory framework which allows innovation throughout the medical device industry, while still providing FDA with the resources it needs to conduct a thorough scientific review and determine a device's suitability for market. FDA must take care to evaluate the increasing need for, and benefits of, improved devices, as well as their relative risk, before making dramatic changes to a process that has successfully delivered continuously improving technology to patients. Having said that, however, any process has room for improvement. Biomet has already made suggestions to both FDA and IoM on how the 510(k) program can be improved without making radical changes, and looks forward to continuing that work in the future.