According to the Federal Food, Drug and Cosmetic Act (FFDCA), all medical device manufacturers must register their facilities and list their devices with the Food and Drug Administration. In the U.S., these devices must generally follow one of two paths to market, either: the Pre-Market Approval (PMA) application process; or the 510(k) Device Clearance “notification” which allows device manufacturers to bypass the more rigorous PMA process entirely. The FFDCA does not require that every medical device on the market in the U.S. be subjected to FDA review. However, those devices which present moderate-to-high risk issues for the health and safety of patients and consumers must be subjected to a review process prior to entry in the market.
Bearing this divergence in mind, the FDA set a new record for device approvals across the board in 2018, with most coming through the 510(k) clearance process. Furthermore, between 1996 and 2009, the FDA approved 48,402 applications through 510(k) clearance and generally speaking, roughly 85% of these applications are cleared annually on the basis that the applicant is “substantially equivalent to an earlier, approved device.
In the meantime, between 2005 and 2009, there were 113 device recalls on the basis of issues that the FDA determined could cause serious health problems or death. Over 71% of these devices were cleared through the 510(k) process. This surge in recalls has prompted many advocates for patient safety to question a system which they feel is allowing too many dangerous devices through which cause harm or worse to the patients they are supposed to help.
Overview of the 510(k) Clearance Process
The FDA regulates virtually every medical device on the market in the U.S. today. The amount and depth of scrutiny, regulatory controls and in some instances, restrictions on marketability, are all tied to the FDA’s medical device classification system. Those device classes are:
| Classification | Threshhold | Examples |
| Class I | General controls are sufficient to provide reasonable asurance of the safety and effectiveness of the device. The device has a low risk of illness or injury to patients. | Elastic bandages, examination gloves, handheld surgical instruments. |
| Class II | General controls are insufficient to provide reasonable asurance of safety and effectiveness of the device. These devices pose a moderate risk to patients. | Powered wheelchairs, infusion pumps, surgical drapes. |
| Class III | Cannot be classified as either Class I or Class II because there is insufficient information that special controls would provide reasonable assurance of the device’s safety and effectiveness. These devices are generally purported to be for use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health. | Heart valves, silicone gel-filled breast implants, implanted cerebella stimulators; metal-on-metal hip joints and certain dental implants. |
Medical devices which fall under Class II and Class III which are not “substantially equivalent” to an already approved medical device must route through the FDA’s rigorous PMA process. That means the device manufacturer will have to submit clinical data to support claims about the safety and effectiveness of the device.
Devices which can claim substantial equivalence to an already approved device may divert through the abbreviated 510(k) process as an alternative to PMA. Instead of demanding evidence for approval, as with the PMA process, the FDA instead “clears” a device for the market as long as the manfucatrer can demonstrate its equivalence to an already approved device. In other words, within 510(k), the FDA is not actually examining any device to determine if the manufacturer’s claims about its safety or effectiveness are actually true. Note: about 80% of all medical devices submitted to the FDA are routed through 510(k) clearance.
510(k) Clearance and Potential Dangers from Lack of Oversight
Medical journals and public interest research groups for years have noted that “fast-tracking” devices to the market, such as through the 510(k) clearance process potentially correlates to a spike in device recalls. One of the most prominent product recalls for a device claiming substantial equivalency involved a common device implanted in thousands of patients. In 2005, the DePuy Orthopaedics division of Johnson and Johnson marketed a new metal-on-metal replacement hip-joint design. The new joint design was cleared through the 510(k) clearance proces and was implanted in over 100,000 people. However, after receiving a barrage of complaints of pain and illness stemming from erosion of the metallic parts, the DePuy hip was recalled in 2010.
Additionally, in 2018, as part of a long-running collaborative investigation between the AP, NBC and the International Consortium of Investigative Journalists, it was learned that across all types of medical devices, more than 1.7 million injuries and 83,000 deaths were reported to the FDA over the previous decade. Between 2008 and 2017, it was found that nearly one quarter of all device injury reports came only from a few devices which went through the truncated approval process:
- Surgical Mesh – 60,795 injuries
- Hip Prosthesis – 103,104 injuries
- Spinal Stimulator – 78,172
- Defibrilator – 59,457
- Insulin Pump Implant – 60,561
- Insulin Pump with Sensor – 94,826
Despite these issues, the FDA does not believe that its role as a regulator has been compromised or rendered less effective than perhaps is believed. Although the agency has expressed some reservations about the limitations of the data it collects and its ability to assess death or injury due to the use of any medical device, it does not believe its oversight role is failing. At a recent industry conference, Dr. Jeffrey Shuren, the Director of the FDA’s Center for Devices and Radiological Health, stated that “There are over 190,000 different devices on the U.S. market. [The FDA] approves or clears about a dozen new or modified devices every single business day… The few devices that get any attention at any time in the press is fewer than the devices we may put on the market in a single business day. That to me doesn’t say that the system is failing. It’s remarkable that the system is working as it does.” He went on to say “Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market…”
The Future of the 510(k) Process
In 2018, the Institute of Medicine (IOM) released a 245-page report evaluating the previous 35 years of the 510(k) process. The report contained broad recommendations and findings, among them that pre-market clearance based on “substantial equivalence” does not generally make for adequate ability to ascertain the safety and effectiveness of medical devices. The report further suggested that the FDA would do better to directed at development of a new pre-market clearance framework combined with more “post-market surveillance” of devices alleged to be harming patients.
Despite these recommendations, Dr. Shuren and the FDA have continued to “build out” the 510(k) program, organizing a new Office of Product Evaluation and Quality in 2019 and issuance of its “Safety and Performance Based Pathway, Special 510(k) Program”. Even so, experts who have followed the FDA’s approach to 510(k) over the years remain skeptical of the agency’s reorganization proposals which they feel are short of the substantial oversight changes they feel are necessary.
Sources Cited (18)
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2) “FDA Regulation of Medical Devices” https://fas.org/sgp/crs/misc/R42130.pdf
3) “IOM, Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and
Other Select Topics” https://www.nap.edu/catalog/13020/public-health-effectiveness-of-the-fda-510k-clearance-process-measuring
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types are approved through the most stringent premarket review process” https://www.gao.gov/products/GAO-09-190
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6) “How Long Does the FDA 510(k) Review Process Really Take?” https://www.meddeviceonline.com/doc/how-long-does-the-fda-k-review-process-really-take-0001
7) “A History of Medical Device Regulation & Oversight in the United States” https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states
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10) “Medical Devices and the Public’s Health” https://www.nap.edu/read/13150/chapter/1#vii
11) “Key Differences Between 510(k) and PMA Pathways at the FDA” https://www.youtube.com/watch?v=05kw8zA27Cg
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13) “Medical Device Recalls and the FDA Process” https://www.ncbi.nlm.nih.gov/pubmed/21321283
14) “FDA to overhaul more than 40-year-old process for approving medical devices that some say puts consumers at risk” https://www.cnbc.com/2018/11/26/fda-to-overhaul-510k-medical-device-approval-process.html
15) “Spinal Cord Stimulators Help Some Patients, Injure Others” https://apnews.com/86ba45b0a4ad443fad1214622d13e6cb
16) “Medical Implant Recalls Raises Questions About 510(k) Review Process” https://uspirg.org/blogs/blog/usp/medical-implant-recalls-raises-questions-about-510k-review-process
17) “Institute of Medicine Report Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years” https://www.policymed.com/2011/07/institute-of-medicine-report-medical-devices-and-the-publics-health-the-fda-510k-clearance-process-a.html
18) “Regulatory Development of the Year: 510(k) changes inch along” https://www.medtechdive.com/news/regulation-fda-medical-device-510k-dive-awards/566238/
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.