The draft of this document was issued on December 13 2012 For questions about this document regarding CDRHregulated devices contact Mary Brady at 3017966089 or by email at marybradyfdahhsgov or contact the Office of the Center Director at 30179659 ID: 12988 Download Pdf
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4 9 DRAFT GUIDANCE ) or the Office of Communication, Outreach, and Development (CBER) at 8004709 or 240 27 U.S. Department of Health and Human ServicesFood and Drug Administration Center for Device
omments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Subm
Document issued on July 15 2014 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the no tice announcing the availability of the draft guidance Submit comments to the Di
Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Submit written
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub
US Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of In Vitro Diagnostic Device Evaluation and Safety Center for Biologic Evaluation and Research brPage 2br Contains NonBinding
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub
1 CHAPTER 1 INITIATING GUIDANCE 5 I UMMARY OF URRENT UIDANCE NITIATION RACTICES 5 A Current Stakeholder Input Prior to Guidance Development 5 B Current DecisionMak ing Processes For In itiating Guid ance 6 II ECOMMENDATIONS 6 CHAPTER 2 PRIORITIZI
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The draft of this document was issued on December 13 2012 For questions about this document regarding CDRHregulated devices contact Mary Brady at 3017966089 or by email at marybradyfdahhsgov or contact the Office of the Center Director at 30179659
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