PDF-Draft Guidance for Industry and Food and Drug Administration Staff ...

4 9 DRAFT GUIDANCE or the Office of Communication Outreach and Development CBER at 8004709 or 240 27 US Department of Health and Human ServicesFood and Drug Administration Center for Device. 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be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit written comments to the Di vision of Dockets Mana Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub The draft of this document was issued on December 13 2012 For questions about this document regarding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 It does not create or confer any rights for or on any person and does not operate to bind FDA or the public You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations If you want to disc Federal Register Federal Register US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER March 2014 ClinicalMedical 16617dftdoc 030614 brPage 2br Guidance for Industry Chronic Fatigue Sy 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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Subm Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to th e Division of Dockets Management H Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Subm US Department of Health and Human Services Food and Drug Administration Center for Devices and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 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 See additional PRA statement in Sec tion VIII of this guidance RU57347TXHVWLRQV57347UHJDUGLQJ57347WKLV57347GRFXPHQW5735957347FRQWDFW57347WKH57347LYLVLRQ57347RI573473UHPDUNHW57347DQG57347DEHOLQJ RPSOLDQFH57347573553 DW57347WKH57347HQWHU57347IRU57347H Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders DRAFT GUIDANCE Communication, Outreach, and Development (CBER) at 800-835-4709 or 240-402-7800. U.S. Departme Representative: First Last. Date: . February . 4. , 2015. Location: . Misc. . Conference Room. Management Review Agenda. Roll Call of Attendees (5.6.1). Suitability of Quality Policy (5.3e). Status of Quality Objectives (.