The Food and Drug Administration (FDA) issued an order requiring manufacturers of certain Class III devices to submit a summary of safety and effectiveness data, and other information currently known to the manufacturers no later than August 7, 2009 (120 days after the notice appeared in the Federal Register on April 9, 2009). These Class III devices are preamendment devices, meaning they were marketed before May 28, 1976, and therefore, the FDA previously has not required such safety and effectiveness information. The FDA will use the information to determine whether the device’s classification should be reclassified into a Class I or Class II device, or whether the device will require an application for Premarket Approval (PMA) or a Product Development Protocol (PDP).
The Safe Medical Device Act (SMDA) mandated that the FDA require manufacturers of medical devices for which the agency had not promulgated final regulations to submit the above-described data summary. Since 1983, the FDA has either reclassified or required PMA’s for 122 of the 149 preamendment devices subject to the SMDA. Twenty-five of the remaining 27 devices are affected by this current FDA order and include the following product types: membrane lung for long-term pulmonary support, intra-aortic balloon and control system, ventricular bypass (assist) device, external pacemaker pulse generator, implantable pacemaker pulse generator, cardiovascular permanent pacemaker electrode, pacemaker programmers, pacemaker repair or replacement material, nonroller-type cardiopulmonary bypass blood pump, external cardiac compressor, external counterpulsating device, automated external defibrillator, endosseous dental implant, mandibular condyle prosthesis, implanted blood access device, sorbent hemoperfusion system, cranial electrotherapy stimulator, electroconvulsive therapy device, female condom, pedicle screw spinal system, hip joint metal/metal semiconstrained, with a cemented acetabular component, prosthesis, hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis, shortwave diathermy, iontophoresis device and the transilluminator for breast evaluation.
The order requires that all manufacturers of the above devices submit information about their devices. Format of the submission depends on whether the manufacturer supports a reclassification of the device into Class I or Class II, or whether the manufacturer is not aware of information supporting reclassification into either class. Reclassification information must include adequate, valid scientific evidence showing that, along with Class I general controls or Class II special controls, the FDA can be reasonably assured of the safety and effectiveness of the device. The manufacturer may submit a formal reclassification petition, or submit data under the order that includes: (1) a narrative identification of the device; (2) an identification of health risks; (3) a statement whether the manufacturer believes the device should be reclassified as Class I or Class II; (4) a summary of the reasons to support the reclassification; and (5) a summary of the valid scientific information upon which the reclassification recommendation is based.
If the manufacturer does not possess valid evidence to support a Class I or Class II reclassification, the submission must generally include the following data: (1) indication for use; (2) device description including function and performance characteristics along with basic scientific concepts that form the basis of the device; (3) other device labeling; (4) a summary of risk information to include adverse safety and effectiveness information; (5) alternate practices and procedures currently in use for the diagnosis, treatment, prevention, cure or mitigation of the disease or condition for which the device is intended; (6) a summary of preclinical and clinical data, including a description of the experimental design, how the data was analyzed and what were the statistical results, the results, the adverse effects, a description of the study population including exclusion and inclusion criteria, reasons for subject discontinuations; and (7) a bibliography of key references with a brief summary of each.