FDA?Medical device news corner

✍ Scribed by Salman, Naser N. ;Richardson, D. Coleman

• Publisher: John Wiley and Sons
• Year: 1988
• Tongue: English
• Weight: 289 KB
• Volume: 22
• Category: Article
• ISSN: 0021-9304
• DOI: 10.1002/jbm.820221304

✦ Synopsis

In this article we will attempt to discuss briefly the regulation governing the medical device (and in uifro diagnostic device) reporting requirements. Because this issue of the Journal of Biomedical Materials Research -Applied Biomateriuls is featuring implant retrieval analysis, we felt it would be appropriate to discuss only the above-mentioned regulation. However, we will resume our series of articles on FDA regulations as they apply to the preparation of Investigational Device Exemption (IDE) and premarket approval application (PMA) submissions in future issues.

On December 13, 1984, the MDR final rule went into effect. Briefly, the regulation requires that manufacturers or importers of medical or in uitro diagnostic products report to the FDA anv "information that reasonably suggests that one of [their] devices (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned. . " and, if malfunction