Most medical devices used in the United States are cleared for marketing through the Food and Drug Administration’s (FDA) 510(k) pathway. Established by the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetics Act, the 510(k) pathway is based on the concept of substantial equivalence. A manufacturer must demonstrate that its product is as safe and effective as a predicate device that has already been cleared and is a legally marketed product.
For years, however, people have been questioning the process and its ability to ensure patient safety. When the FDA and Congress looked into these concerns in 2011, they found that the 510(k) wasn’t functioning as it was originally intended. Changes were implemented to discontinue multiple predicate submissions, enhance postmarket surveillance, and increase emphasis on the use of evidence from registries to supplement existing safety and effectiveness data. Now that devices are taking another leap forward with new technologies and more combinations with drugs and biologics, the FDA is again preparing to evaluate the 42-year-old process. In its November 2018 statement, the FDA expressed its belief that “new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria.” The agency reports that its data show that nearly 20 percent of current products cleared via 510(k) were based on predicates that were more than 10 years old.
To ensure that products are “continually improving,” as demonstrated by sponsors referencing newer technologies in applications, the FDA is considering making public a list of cleared devices that demonstrate substantial equivalence to older predicate devices, with a focus on predicates that are more than 10 years old. The agency believes that public awareness and market-driven demands for newer technology will promote innovation. It plans to solicit feedback on the proposed approach, including whether to make the aforementioned list public, whether to sunset older predicates, and whether to add criteria to assist in selecting reference products. AAOS plans to submit comments on these proposals, including language outlining the possible unintended consequences of selecting arbitrary cutoff dates for predicate age.
Some are concerned about the FDA’s approach and see no need to target a practice that is working well. A post from the FDA Law Blog compared 510(k) predicate information from a 2014 Food and Drug Law Journal article and a sample of submissions from 2017–2018. The results show a mean predicate age of 76 months and a median predicate age of 52 months, suggesting that the market already favors newer predicates. The blog cited orthopaedic submissions that comingled newer and older predicates for its constituent components. The older predicate was a bone screw. The authors noted that bone screws are not a rapidly evolving device type. Therefore, the inclusion of the older predicates still reflects the best technology. This comparison illustrates one concern with the FDA’s approach to modernizing the 510(k) pathway and targeting practices that are working well.
Clarification of the de novo pathway
In cases where no predicate device exists and the device is not a type that was marketed before the 1976 amendments, applications are automatically considered to be class III devices and must go through premarket approval. This is a longer and more expensive process for devices, where general and special controls are not sufficient to provide a reasonable assurance of safety and effectiveness. For novel devices that can provide reasonable assurance of safety and effectiveness, through the use of general controls or a combination of general and special controls, the de novo pathway provides an alternative. Products that are classified as class I or II via de novo may be used as predicates for future 510(k) submissions.
The FDA released a proposed rule on Dec. 5, 2018, with the goal of streamlining the de novo pathway. The proposed rule includes clarified procedures and submission requirements for de novo requests. The agency hopes that the clear standards, expectations, and processes for this pathway will drive more submissions through de novo, thereby expediting the delivery of novel devices to patients.
Protecting patients, promoting public health
Following the launch of the FDA’s Medical Device Safety Action Plan, the agency set a new goal for device safety: ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. This is an ambitious goal, given the scope of the U.S. healthcare market, diversity of the population, and challenges inherent in connecting all signal sources. The FDA currently regulates more than 190,000 different devices, and the number grows by 12 new or modified devices each business day.
Central to the agency’s ability to monitor devices is the National Evaluation System for Health Technology (NEST), which was one of the Center for Devices and Radiological Health’s 2016–2017 strategic priorities. The system will “link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records, and medical billing claims.” Combined with a unique device identification system and enhanced postmarket surveillance, NEST aims to improve the quality of evidence available to patients, clinicians, industry, and the FDA. The data may help address questions that cannot be answered, even with well-designed premarket studies, and enable technology to come to market as additional information about safety and effectiveness is developed.
Katherine Sale is a senior manager in the AAOS Office of Government Relations.
- Food and Drug Administration: Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626572.htm. Accessed January 18, 2019.
- Koblitz SW: C. Escher by Way of Generic Drug Pricing. Available at: http://www.fdalawblog.net/. Accessed January 18, 2019.
- Food and Drug Administration: Evaluation of Automatic Class III Designation (De Novo). Available at: https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/ucm462775.htm. Accessed January 18, 2019.
- Office of the Federal Register: Medical Device De Novo Classification Process. Available at: https://www.federalregister.gov/documents/2018/12/07/2018-26378/medical-device-de-novo-classification-process. Accessed January 18, 2019.
- Food and Drug Administration: National Evaluation System for Health Technology (NEST). Available at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm301912.htm. Accessed January 18, 2019.