William A Cook Australia Pty Consult company before releasing information. Follow Ltd similar guidelines to the FDA. Global Orthopaedic Technology Information not currently released on public ARTG summary as it is commercial in confidence. Rejections be used by competitors as a marketing tool. Information may be accidently released when not to. All relevant information already included in public ARTG summary. Integra Neurosciences Pty Ltd No health and safety benefit of publicising unsuccessful decisions. Name withheld at submitters Successful III, AIMD and Class IIb implantable request application decisions publicised only. Do not include automatic entries, “interesting products”, unsuccessful decisions, and conformity assessment decisions. Name withheld at submitters Approval decisions for application for inclusion only. request No benefit to public if rejections are published. Concerns that publication will delay ARTG inclusion. Clarification required if this is similar to AusPAR. Name withheld at submitters Class III, AIMD, and Class IIb implantable to be request publicised, if rejected- only information on safety and efficacy to be published for rejected applications. If publish low risk decisions- only successful applications.
William A Cook Australia Pty Ltd Consult company before releasing information. Follow similar guidelines to the FDA. Global Orthopaedic Technology Information not currently released on public ARTG summary as it is commercial in confidence. Rejections be used by competitors as a marketing tool. Information may be accidently released when not to. All relevant information already included in public ARTG summary. Integra Neurosciences Pty Ltd No health and safety benefit of publicising unsuccessful decisions. Name withheld at submitters request Successful III, AIMD and Class IIb implantable application decisions publicised only. Do not include automatic entries, “interesting products”, unsuccessful decisions, and conformity assessment decisions. Name withheld at submitters request Approval decisions for application for inclusion only. No benefit to public if rejections are published. Concerns that publication will delay ARTG inclusion. Clarification required if this is similar to AusPAR. Name withheld at submitters request Class III, AIMD, and Class IIb implantable to be publicised, if rejected- only information on safety and efficacy to be published for rejected applications. If publish low risk decisions- only successful applications.
consult-ris-medical-devices-premarket-assessment-130510-1.docx