Biomedical Engineering - Regulatory Issues

Regulatory Issues

Regulatory issues are of particular concern to a biomedical engineer; it is among the most heavily-regulated fields of engineering, and practicing biomedical engineers must routinely consult and cooperate with regulatory law attorneys and other experts. The Food and Drug Administration (FDA) is the principal healthcare regulatory authority in the United States, having jurisdiction over medical devices, drugs, biologics, and combination products. The paramount objectives driving policy decisions by the FDA are safety and efficacy of healthcare products.

In addition, because biomedical engineers often develop devices and technologies for "consumer" use, such as physical therapy devices (which are also "medical" devices), these may also be governed in some respects by the Consumer Product Safety Commission. The greatest hurdles tend to be 510K "clearance" (typically for Class 2 devices) or pre-market "approval" (typically for drugs and class 3 devices).

Most countries have their own particular mechanisms for regulation, with varying formulations and degrees of restrictiveness. In most European countries, more discretion rests with the prescribing doctor, while the regulations chiefly assure that the product operates as expected. In European Union nations, the national governments license certifying agencies, which are for-profit companies. Technical committees of engineers write recommendations which incorporate public comments, and these can be adopted as regulations by the European Union. These recommendations vary by the type of device, and specify tests for safety and efficacy. Once a prototype has passed the tests at a certification lab, and that model is being constructed under the control of a certified quality system, the device is entitled to bear a CE mark, indicating that the device is believed to be safe and reliable when used as directed.

The different regulatory arrangements sometimes result in particular technologies being developed first for either the U.S. or in Europe depending on the more favorable form of regulation. While nations often strive for substantive harmony to facilitate cross-national distribution, philosophical differences about the optimal extent of regulation can be a hindrance; more restrictive regulations seem appealing on an intuitive level, but critics decry the tradeoff cost in terms of slowing access to life-saving developments.