Medical devices, which run the gamut from simple tongue depressors and thermometers to cardiac defibrillators and pacemakers, as well as a wide range of implantable and prosthetic devices, are regulated differently from pharmaceuticals in the United States and other countries, with less stringent requirements for initial clearance and safety follow-up.
The large number of recalls of medical devices has pointed to a need for more active monitoring of product performance from the standpoints of both safety and efficacy.
Medical Device Approval Process in the United States
In the United States, medical device safety has been regulated under the US Food and Drug Administration (FDA) since 1976 by the Medical Device Amendments to the Food, Drug and Cosmetic Act,1 with the responsibility of evaluating new devices according to a standard of “reasonable assurance of safety and effectiveness.”2 To that end, the FDA divided medical devices into 3 regulatory classes according to the degree of potential risks to their use:
- Class I (low risk), General Controls: Most class I devices are registered with the FDA without submitting to a premarket approval process. These products are expected to adhere to general quality control guidelines for manufacturing, packaging, and storage according to good manufacturing processes already defined.
- Class II (moderate risk), General Controls with Special Controls: These devices are reviewed more carefully and need to meet standards of substantial equivalence to existing products to be cleared using a Premarket Notification 510(k) application. This process requires manufacturers to notify the FDA at least 90 days in advance of their intent to market a new medical device or of significant changes in the design, material, chemical composition, energy source, manufacturing process, or intended use of a device already in use.
- Class III (high risk), General Controls with Special Controls and Premarket Approval: Class III devices undergo the most rigorous examination by the FDA through a Premarket Approval application process that requires submission of preclinical data to support the safety and efficacy claims for the product.
A 2012 review by Kramer et al reported that an estimated two-thirds of medical devices were marketed without any formal evaluation by the FDA other than registration, and a substantial number of high-risk devises were cleared with only the minimal requirements of 510(k) approval.3 In a 2013 study of approvals of hospital-based technologies, Boudard et al concluded that “only a few studies of innovative medical devices provide high-level clinical evidence.”4
Postmarket Medical Device Surveillance in the United States
The Medical Device Reporting system required by the FDA is the primary mechanism for capturing postmarket events relating to the use of medical devices in the United States. Two types of reports are collected that provide safety information on adverse events associated with the use of medical devices:
- Mandatory reports are required of device manufacturers, facilities using devices (including hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, or outpatient treatment facilities), and device importers in any case in which a device “may have caused or contributed to a death or serious injury.”
- Reports of device malfunctions are not required, but may be voluntarily submitted using the MedWatch Form FDA 3500 under the FDA’s Safety Information and Adverse Event Reporting Program. In addition, healthcare professionals, caregivers, patients, and consumers may submit voluntary MedWatch reports of any significant adverse events or problems with medical device products.
Examination of device recalls issued after the occurrence of adverse events that have resulted in serious harm or death from use have pointed to the application of less stringent requirements for initial approvals of many of these products.
A 2011 study by Zuckerman et al found that 78% of 113 devices recalled by the FDA for life-threatening causes during the period from 2005 to 2009 had originally been cleared under the 510(k) process, often requiring no specific proof of safety for the specific device.5 Cardiovascular devices make up 27% of recalls, comprising the largest group of products,6 Despite this, a 2014 study by Somberg et al6 demonstrated that 81% of all cardiovascular devices were cleared through the 510(k) process compared with only 19% approved through PMA.
Methods for Adopting Active Surveillance of Medical Devices
The main mechanisms for the monitoring of device safety are passive reporting systems that collect minimal information only after a serious or life-threatening event has occurred. The major markets for medical devices around the world, including the United States, European Union, China and Japan were reported by Kramer et al to “share broad features in their approaches to post-approval monitoring, such as a heavy reliance on passive adverse event collection for marketed devices.”7
Each year, new technologies are developed and integrated into more fields of medicine, strongly pointing to the need for new strategies to monitor the continuing safety and efficacy of these devices in a more timely and effective manner. The Somberg review recommended enhancing the 510(k) process to include more rigorous premarket testing along with conditional 2-year approval and mandatory participation in a device registry to track adverse events.6
A 2017 study of a national registry for the Mynx vascular closure device supported the benefits to the registry approach.8 After data from 73,124 recipients of the Mynx vascular closure device were evaluated, the investigators reported that the registry prospectively and rapidly identified markers of potential safety risks within 3 predetermined high-risk groups, sending out alerts within 12 months of initial implantation.8
The FDA has improved its mechanisms for tracking emerging problems with devices already on the market. The Medical Product Safety Network (MedSun) was created to enhance existing reporting systems by evaluating and reporting on early signs of potential safety problems with devices to project future risks.9 In addition, the FDA developed a draft guidance for the implementation of a unique device identifier program that can be tied to electronic reporting systems and provide greater tracking of the performance of individual devices, as well as patterns among groups of devices.10
Implementation of these strategies, together with a more appropriate use of the 3 application levels to adhere to stronger premarket requirements for approval, promises to improve the safety and efficacy of medical devices in the future.
- Medical Device Amendments. Pub. L. No. 94-295, 90 Stat. 539. 1976.
- Jarow JP, Viviano C, Baxley JH. How much clinical evidence is enough: regulation of medical devices? Ann Transl Med. 2016 Oct;4(20):414. doi: 10.21037/atm.2016.08.44
- Kramer DB, Xu S, Kesselheim AS. How does medical device regulation perform in in the United States and European Union? A systematic review. PLOS Med. 2012;9(7):e1001276. doi: 10.1371/journal.pmed.1001276
- Boudard A, Martinelli N, Prognon P, et al. Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment? J Eval Clin Prac. 2013;19(4):697-702. doi: 10.1111/jep.12024
- Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011;171(11):1006-1011. doi: 10.1001/archinternmed.2011.30
- Somberg JC, McEwen P, Molnar J. Assessment of cardiovascular and noncardiovascular medical device recalls. Am J Cardiol. 2014;113(11):1899-1903. doi: 10.1016/j.amjcard.2014.03.024
- Kramer DB, Tan YT, Sato C, et al. Ensuring medical device effectiveness and safety: a cross-national comparison of approaches to regulation. Food Drug Law J 2014;69(1):1-23.
- Resnic FS, Majithia A, Dabic DM, et al. Registry-based, prospective, active surveillance of medical device safety. N Engl J Med 2017;376(6):526-535. doi: 10.1056/NEJMoa1516333
- US Food and Drug Administration. MedSun: Medical Product Safety Network. http://www.fda.gov/medicaldevices/safety/medsunmedicalproductsafetynetwork/default.htm. Accessed December 2, 2013.
- 126. Federal Register. Global unique device identification database; draft guidance for industry. https://www.federalregister.gov/documents/2013/09/24/2013-23058/global-unique-device-identification-database-draft-guidance-for-industry-availability. Accessed December 2, 2013.