News: June 19, 2007
Intervertebral Body Fusion Devices that Contain Bone Grafting Material Reclassified as Class II. The reclassification does not cover intervertebral body fusion devices that contain any therapeutic biologic, such as bone morphogenic protein, which will remain as class III devices subject to premarket approval. FDA has also issued a special controls guidance document to support this reclassification. The guidance document is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-11235.htm.
Intervertebral Body Fusion Devices that Contain Bone Grafting Material Reclassified as Class II. The reclassification does not cover intervertebral body fusion devices that contain any therapeutic biologic, such as bone morphogenic protein, which will remain as class III devices subject to premarket approval. FDA has also issued a special controls guidance document to support this reclassification. The guidance document is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-11235.htm.
New FDA Risk Communication Advisory Committee Formed. The 15-member committee composed entirely of non-FDA staff will address the communication of risks and benefits of FDA -regulated products, including medical devices, and provide guidance to the agency on how best to communicate this information to the public to avoid unnecessary panic, as illustrated by the Guidant recall of implantable defibrillators. Additional information is available at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01648.html.
Safety of Devices Used in the Home to be Focus of Upcoming FDA Meeting. Hosted by the Center for Devices and Radiological Health's Home Health Care Committee, the meeting, to take place September 17-18 in Houston, Texas, will focus on finding non-regulatory ways to ensure the safe use of medical devices in the home. FDA is seeing a rise in device-associated deaths and serious injuries from the use of devices in the home. Home use is occurring with more frequency as more and more patients are being cared for in the home. Additional information is available at http://www.fda.gov/cdrh/CDRHHHC/091707-conference.html.
Abbott Laboratories Voluntarily Recalls Architect STAT Trophin-I Immunoassay. The immunoassay is used by clinical laboratories in diagnosing damage to the heart and myocardial infarction in people experiencing chest pain. The class I recall was due to a number of clinical laboratories reporting inconsistent or invalid test results at certain levels of trophin-I, leading to falsely elevated or falsely decreased results. Additional information is available at http://www.fda.gov/cdrh/recalls/recall-030807.html.