FDA looks at calcium salt bone void filler:
This article was originally published in Clinica
The US FDA has proposed to classify resorbable calcium salt bone void filler used to fill bony voids or gaps caused by trauma or surgery into class II special controls (a guidance document has been released at the same time). The reclassification applies to those fillers that are not intrinsic to the stability of the bony structure. The product was on the market prior to 1976 when the amendments to US Food and Drug law establishing medical device regulation went into effect and therefore was allowed to remain on the market until it could be classified by the agency. The FDA inadvertently left the product off the list when it classified other pre-amendment products in 1987. Comments are due on May 8.