Medical devices; illustrative and designated lists for device tracking--FDA. Final rule and request for comments.
The Food and Drug Administration (FDA) is amending the medical device tracking regulations to add the temporo-mandibular joint prostheses to the illustrative list of devices and the penile inflatable implant to the list of devices designated for tracking. These devices are being added to the illustrative and designated device lists based on the significance of the risk to health posed by their use. This action requires manufacturers to track these devices after distribution so that they can be located in the event of a recall or patient notification action. FDA requests comments on these changes. Elsewhere in this issue of the Federal Register, the agency is announcing notification of the change of status of the device tracking regulations and is suspending the effective date of the regulations until August 29, 1993.
D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D007221:Industry / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D019736:Prostheses and Implants / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration