Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

2.5.1 U.S. Food and Drug Administration

FDA is responsible for ensuring that medical devices that manufacturers want to introduce into commerce in the U.S. are safe and effective for their intended uses and user populations.

FDA’s Quality System Regulation was codified in Title 21, Part 820 of the Code of Federal Regulations (21 CFR 820), which incorporates current good manufacturing practice (cGMP) requirements. The regulation requires manufacturers to follow a rigorous and multifaceted process for design, manufacturing, post-market review and adverse event reporting of medical devices and accessories. These include implementation of design controls, document controls, purchasing controls, product identification and traceability, production and process controls, criteria for acceptance and non-conformance of products, corrective and preventive actions, labeling (including user information, marketing claims, and product promotion), storage/distribution/installation, record keeping, and servicing. These requirements mean that few changes to medical devices can be treated as “small” and rigorous processes must be followed to ensure the product continues to perform as designed and intended in a reliable and safe fashion.

FDA classifies medical devices based on the level of risk of harm they present to patients and users. There are three classes, ordered from low to high risk: Class I, II, and III. With few exceptions, the medical diagnostic equipment covered by the proposed accessibility standards is either FDA Class I or Class II.

• Class I devices typically do not require any form of premarket clearance or approval from the FDA, but the manufacturers are still required to follow the FDA Quality System Regulation (in 21 CFR 820) and are subject to FDA audit. Examples include examination tables and chairs.

• Class II devices are required to follow the FDA Quality System Regulation and usually must receive FDA clearance prior to being introduced into commerce in the US. To receive FDA clearance, the manufacturer must submit a premarket notification (known as a “510(k)” per 21 CFR 807, Subpart E) if a device is being introduced into commercial distribution for the first time, or if a device has been changed in a way that could significantly affect the device’s safety or effectiveness. The FDA performs scientific and clinical reviews of the contents of 510(k) submissions to determine whether the device is substantially equivalent to a predicate device already in commercial distribution. Examples include most diagnostic imaging systems.

• Class III devices either represent new device technologies or are devices (such as life supporting devices) that are associated with the highest levels of risk because they have the greatest potential for adverse public health effects if problems, such as device malfunctions or use errors, occur. This class of devices must go through a more rigorous FDA premarket process, specified in 21 CFR 814, for premarket approval (PMA). Currently only some digital mammography devices covered under the proposed accessibility standards fall into this classification.

FDA would become involved in implementation of the proposed accessibility standards when a manufacturer wants to introduce into commercial distribution in the U.S. a new medical device or device accessory that complies with the standards or to modify an existing device to comply with the standards (Section 7.4 describes this process in greater detail). All devices that fall into Class II or Class III are subject to the FDA premarket clearance or approval process. FDA reviews the premarket submission to confirm that the device is safe and effective for its intended uses and user population. In addition, a manufacturer stating in its labeling that the device conforms to the new standards would be making a marketing claim that FDA would then be required to review and verify was accurate. A manufacturer who could comply only partially with the new standards could identify the aspects of the device that meet the requirements in the standards and, therefore, meet the criteria for FDA to allow them to be described in the device labeling as “accessible.” However, any final determinations of accessibility would be made by the Department of Justice, which will be responsible for issuing any enforceable medical equipment standards. Such determinations will stem not only from the design of the medical equipment but also other concerns, such as the placement of the equipment in examination rooms.