FDA Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Device tracking: 1Medical device tracking final rule amending 1993 reg to reflect changes under FDAMA is effective May 9. No revisions are made to the April 25, 2000 proposed rule (2"The Gray Sheet" May 1, 2000, In Brief). The rule "makes no revisions to the regulation's existing system and content tracking requirements, the current obligations of persons other than device manufacturers, such as distributors, records and inspection requirements and existing record retention requirements." A final guidance on medical device tracking was issued Jan. 24, 2000...
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Bone void filler guidance finalized
"Bone void filler devices composed of alternate materials may be demonstrated to be substantially equivalent...to the resobable calcium salt bone void filler device identified in this guidance," FDA notes in its 1Class II special controls guidance on bone void fillers. However, FDA cautions that the guidance addresses only submission requirements and risk mitigation measures for resorbable calcium salt intended to fill bony gaps not intrinsic to the stability of the bony structure. Posted on the CDRH website May 28, the final guidance supersedes a Feb. 7, 2002 draft issued following a petition to reclassify Wright Medical Technologies' Osteoset into Class II (2"The Gray Sheet" Feb. 11, 2002, p. 11)...
Bone void filler guidance finalized
"Bone void filler devices composed of alternate materials may be demonstrated to be substantially equivalent...to the resobable calcium salt bone void filler device identified in this guidance," FDA notes in its 1Class II special controls guidance on bone void fillers. However, FDA cautions that the guidance addresses only submission requirements and risk mitigation measures for resorbable calcium salt intended to fill bony gaps not intrinsic to the stability of the bony structure. Posted on the CDRH website May 28, the final guidance supersedes a Feb. 7, 2002 draft issued following a petition to reclassify Wright Medical Technologies' Osteoset into Class II (2"The Gray Sheet" Feb. 11, 2002, p. 11)...
Regulatory News In Brief
FDA MDUFMA stakeholder meeting: Year-end meeting for the week of Dec. 1 on the Medical Device User Fee & Modernization Act is being considered in lieu of a mid-year event, according to FDA staffers. The full-day December meeting likely will be held in the Washington, D.C. area. The agency initially had planned to hold a half-day meeting June 6, but chose to delay the date due to a conflict with the Medical Device Manufacturers Association's annual meeting (1"The Gray Sheet" May 5, 2003, In Brief)....MDUFMA billing update: FDA 2chart explaining payment instructions for normal payment, courier/delivery services and wire transfer procedures is posted May 15 on the agency's MDUFMA web page. Separately, 3CDRH MDUFMA billing contacts are listed May 13. General questions related to payment of 510(k) and PMA fees should be directed to Jim Norman, and general appeals questions should go to Bob Navazio. The Division of Small Manufacturers, International and Consumer Assistance will answer queries about small business fees and waivers...