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.
This article originally appeared on Psychiatry Advisor