Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Postapproval study penalties: The Office of Surveillance & Biometrics may enforce civil money penalties when manufacturers fail to conduct condition of approval (CoA) studies, OSB Director Susan Gardner warns at an FDA Gastroenterology & Urology Device Panel meeting in Gaithersburg, Md., June 8. The device would be labeled as misbranded, she stressed. Gardner further noted that an automated OSB tracking system of CoA commitments is operational and the status of postmarket studies will be made available publicly on CDRH's website (1"The Gray Sheet" Oct. 25, 2004, p. 10). FDA and AdvaMed reps plan to meet June 21 to discuss challenges to meeting postmarket pledges...
You may also be interested in...
Radiological health meeting
Center for Devices & Radiological Health plans an Oct. 31-Nov. 1 public meeting to get stakeholder input how to implement its new Radiological Health Program goals outlined in a June report on "Adapting to Current Public Health Needs - 2005-2010" (1"The Gray Sheet" June 13, 2005, p. 13). Topics of discussion will include the increased reliance on radiation safety standards, new strategies for monitoring manufacturing of radiation-generating products and training issues. Prospective participants must register by Oct. 17...
Radiological health meeting
Center for Devices & Radiological Health plans an Oct. 31-Nov. 1 public meeting to get stakeholder input how to implement its new Radiological Health Program goals outlined in a June report on "Adapting to Current Public Health Needs - 2005-2010" (1"The Gray Sheet" June 13, 2005, p. 13). Topics of discussion will include the increased reliance on radiation safety standards, new strategies for monitoring manufacturing of radiation-generating products and training issues. Prospective participants must register by Oct. 17...
CDRH Science Office Will Team With Industry On Internal Research Agenda
CDRH's Office of Science & Engineering Laboratories will consult with industry and academia experts in a fall evaluation of device research projects, according to Director Larry Kessler