Medical Devices

European Union's Regulatory Process Gao ID: HEHS-98-19R November 20, 1997

Pursuant to a congressional request, GAO compared the Food and Drug Administration's (FDA) and the European Union's (EU), systems for regulating the entry of medical devices into the marketplace, focusing on product review time.

GAO noted that: (1) there are some differences between the EU and FDA systems that might explain why the EU system may conduct reviews more rapidly than FDA, but at least one difference makes it difficult to reach valid conclusions about the relative speed of review under the two systems; (2) a manufacturer who seeks to market a medical device in the EU has two general types of choices that can affect the speed of clearance--the type of procedure used to assess the device and the amount of resources devoted to this assessment; (3) regarding the first choice, the EU requires an assessment of both the device's design and its manufacturing process to determine whether any associated risk is acceptable given the benefits of the device; (4) variations permitted in how the design and manufacturing process are assessed affect the length of time the assessment takes; (5) in the United States, manufacturers have no choice; (6) the procedure used to clear a device for U.S. marketing depends on the kind of device it is; (7) if a device does not require premarket approval, FDA may clear the product if the manufacturer can show that the new device is substantially equivalent in safety and effectiveness to a similar device already on the market; (8) otherwise, FDA requires that the manufacturer show, through the premarket approval process, that the device is safe and effective; (9) the second choice available to manufacturers in the EU relates to the amount of resources devoted to the assessment; (10) manufacturers contract with a third party to conduct the assessment at a cost that is negotiated between the two; (11) in the United States, FDA conducts all reviews and makes all decisions about resources used for product review; (12) although manufacturers' flexibility under the EU system can contribute to more rapid review times, comparisons of review times must be made with caution; (13) medical devices assessed under the EU system are likely to be different from those entering review by FDA--that is, many of the assessments that EU conducts are of products that have already been cleared for marketing in the countries where they are sold; (14) under EU regulation, manufacturers must show that all devices sold conform with EU requirements; (15) where the EU requirements are similar to those in countries that are already selling the devices, the EU assessments should be relatively rapid; and (16) for such devices, the EU assessment represents a second review than those conducted by FDA, all of which are of devices that have never been reviewed before.

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