In recent years, the FDA’s premarket notification process has been challenged as an ineffective tool for assuring that safe and effective devices enter the marketplace. That criticism, however, is too broad and fails to recognize the overall success of how medical devices are regulated within the United States.
The premarket notification process was not inherently defective. The FDA had neglected to set clear lines within the agency to determine if a device was substantially equivalent to a preamendment device, or was postamendment and required premarket approval. The process was at times too ad hoc and did not always result in the best or even consistent decisions. The FDA is in the process of re-evaluating the premarket notification processes.
The FDA’s application of general controls has largely been very successful. An area of concern is the quality systems regulation. The agency has been raising the bar at the local level via individual FDA investigators making observations when performing plant audits. Manufacturers will not usually challenge these ad hoc requirement enhancements. The FDA should only raise the bar at the national level by periodically issuing guidance documents both for internal and industry use.
It might be helpful to consider the current regulatory environment from a long-term perspective. For many years after devices were added to the Food, Drug, and Cosmetic Act in 1938, they were regulated under the labeling authority of the act. The act was amended in 1976 to provide increased authority.
The ‘76 amendments represented a forward-looking approach for the regulation of devices. They provided for three levels or classes of regulation: premarket approval (Class III), standards (Class II), and general controls (labeling, quality systems, registration of manufacturing sites, listing of devices being marketed, adverse event reporting, and, as appropriate, premarket notification) that applied to all classes, but were the regulatory tools for regulation of Class I devices.
A majority of manufacturers are small businesses. Device life cycles can be very short due to the development of new technology/materials and medical advances—for example, cat scanners, drug-eluting stents, and LASIK surgery. Technology changes through the introduction of new models with enhanced features. The device provisions of the act have provided the flexibility needed to continue to assure that new devices reach the market within reasonable time frames.
The initial regulatory scheme for the use of FDA-generated standards was a failure. The process was too prescriptive and not realistic. In 1990, the act was amended. One of the revisions provided the FDA with the authority to recognize national and international consensus standards. The United States and several other countries (for example, Canada and Australia), along with regional regulatory bodies, have processes to recognize parts or complete standards as tools to assure the safety and effectiveness of devices marketed in their countries. This has made standards very important to industry and provides an incentive for active participation.
Overall, the original ‘76 amendments and later revisions related to devices have resulted in a reasonable regulatory process to provide safe and effective devices to the public. As as the case with any complex process, it is important that the FDA continually review its procedures and secure input from consumers and industry before making significant changes. The FDA should make greater use of third parties to conduct plant audits and process premarket notifications,which are the primary methods utilized in the EC.
Leighton Hansel recently retired as director of regulatory affairs at Abbott Laboratories. He is a member of the AAMI Board of Directors and is a former manager with the U.S. Food and Drug Administration, where he worked in the agency’s medical device program, focusing on regulatory and postmarket surveillance.