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This article was originally published in The Gray Sheet

Executive Summary

DIAGNOSTIC IMAGING EQUIPMENT COMPLIANCE WITH VOLUNTARY STANDARDS is being proposed to FDA by the National Electrical Manufacturers Association as an alternative to 510(k) data requirements. NEMA's diagnostic imaging and therapy systems division is developing a proposal that would enable manufacturers to obtain marketing clearance for diagnostic imaging devices based on a 510(k) submission that consists of a device description and certification that the product is in compliance with applicable voluntary standards. The association plans to meet with FDA device center staffers in late April to discuss the proposal. Initially, the association will ask FDA to apply the modified 510(k) procedure to x-ray and computed tomography equipment, the two most mature imaging technologies. If the program is successful, NEMA would seek expansion of the program first to other types of diagnostic equipment devices such as magnetic resonance imaging and ultrasound and then to therapy equipment such as lithotripters and linear acceleration devices. Voluntary standards could serve as the basis for 510(k) submissions because their requirements duplicate many of FDA's safety and effectiveness data requirements for 510(k)s, according to NEMA. The association says that adequate horizontal standards already exist for diagnostic imaging equipment in the form of the International Electrotechnical Committee's IEC 601-1 safety standard for electromedical devices. In addition, NEMA identifies IEC 601-2-7 as a promising vertical standard for use in x-ray and, to some extent, computed tomography 510(k) submissions. IEC also is developing standards for ultrasound, magnetic resonance imaging and lithotripsy. FDA is interested in increasing the use of voluntary standards in its regulatory programs. For example, speaking at a conference of the Association for the Advancement of Medical Instrumentation in November, Melvyn Altman, associate director of the device center's office of standards and regulations, said that the agency may adopt IEC 601-1 as a voluntary standard or guideline ("The Gray Sheet" Nov. 16, 1992, p. 23). The agency also has a guidance on the use of voluntary standards in the works ("The Gray Sheet" Feb. 15, In Brief). NEMA is hoping that the proposal will be attractive to the device center as a resource-conserving way to reduce the backlog of pending 510(k)s. Under the system, the agency could use its regular GMP inspection program as the primary compliance tool. The NEMA proposal also is likely to suggest the creation of FDA/industry working groups for each type of diagnostic imaging equipment. The groups would work to identify appropriate standards with which manufacturers could certify compliance. When NEMA presents the plan to FDA, it will be the second time in four years that the association has approached the agency about using standards to facilitate 510(k) clearances. In 1989, the association floated a proposal for an "expedited" 510(k) procedure for certain diagnostic x-ray and computed tomography equipment. NEMA suggested that manufacturers could fulfill 510(k) requirements by certifying compliance with the Radiation Control for Health and Safety Act and applicable voluntary standards ("The Gray Sheet" Aug. 14, 1989, p. 8). NEMA subsequently asked FDA to table the petition, in part because of the difficult regulatory climate at the time due to the generic drug scandal.



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