Threads Tagged with fda (food and drug administration)

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Threads Tagged with fda (food and drug administration)

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Threads Tagged with fda (food and drug administration)
	Discussion Thread Title / Thread Starter	Last Post or Poll Vote	Replies	Views	Forum
	Device Retains - How many people keep retains of finished devices and why? VTARA started this discussion on 15th February 2012	17th June 2013 11:47 AM by MIREGMGR	6	890	US Food and Drug Administration (FDA)
	Looking for Adverse Event guidance Bunny started this discussion on 12th June 2013	13th June 2013 10:36 AM by Ronen E	4	221	US Food and Drug Administration (FDA)
	Proposed reclassification of Ultraviolet (UV) Lamps intended to tan the skin Ronen E started this discussion on 10th May 2013	11th June 2013 02:15 AM by Stijloor	1	187	Other US Medical Device Regulation Topics
	New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Reporting ( 1 2) sreenu927 started this discussion on 25th February 2013	10th June 2013 09:02 AM by MIREGMGR	15	720	Other US Medical Device Regulation Topics
	How to Prepare for an FDA Inspection ( 1 2) tallu started this discussion on 8th May 2013	8th June 2013 08:09 AM by markspend01	15	848	US Food and Drug Administration (FDA)
	Electronic submissions to the FDA raghu_1968 started this discussion on 6th June 2013	6th June 2013 04:30 PM by MIREGMGR	3	187	US Food and Drug Administration (FDA)
	Process Validation Protocol (API) as per new FDA Guidelines ( 1 2 3) dinu344 started this discussion on 8th March 2011	6th June 2013 01:03 PM by v9991	19	9,477	Qualification and Validation (including 21 CFR Part 11)
	Use of non consensus ISO standards in Marketing Material ( 1 2) VTARA started this discussion on 30th May 2013	5th June 2013 05:53 PM by OccamMan	11	367	US Medical Devices (21 CFR part 820)
	Is a Distributor responsible for Design History Files ( 1 2) adv_webdev started this discussion on 25th March 2010	30th May 2013 01:34 PM by MIREGMGR	9	967	US Medical Devices (21 CFR part 820)
	What documents would an FDA auditor want to see in an FDA Audit of Quality System ( 1 2) apriljoyc started this discussion on 23rd May 2013	30th May 2013 11:55 AM by apriljoyc	9	501	US Medical Devices (21 CFR part 820)
	CDRH Appeals Process - New FDA Guidance Document sreenu927 started this discussion on 16th May 2013	29th May 2013 06:49 AM by Stijloor	1	351	Other US Medical Device Regulation Topics
	FAQ Thread: Facts About Current Good Manufacturing Practices (cGMPs) Ajit Basrur started this discussion on 30th March 2013	27th May 2013 12:39 PM by v9991	4	553	US Food and Drug Administration (FDA)
	FDA Regulations for Research and Development ( 1 2) Weeder started this discussion on 7th May 2013	27th May 2013 09:56 AM by v9991	10	468	US Food and Drug Administration (FDA)
	General Controls - GMP interpretation? General Requirements Concerning Records ( 1 2) Aphel started this discussion on 2nd December 2011	25th May 2013 09:03 PM by Ronen E	11	1,470	US Medical Devices (21 CFR part 820)
	Australia/Canada and USA v's EU Medical Devices Regulations Comparison lenwelshlass started this discussion on 22nd May 2013	24th May 2013 07:23 PM by Ronen E	4	266	Other Medical Device Regulations World-Wide
	Regulatory and Safety Standards for Veterinary Medical Devices ( 1 2) somashekar started this discussion on 26th March 2010	24th May 2013 10:07 AM by MIREGMGR	10	4,680	Other Medical Device Related Standards
	FDA Reclassification of Medical Devices - Class III device down to Class II deuce64 started this discussion on 23rd May 2013	24th May 2013 04:07 AM by Gert Sorensen	2	205	US Medical Devices (21 CFR part 820)
	Is a Quality Manual a requirement for FDA registration? rvanelli started this discussion on 13th May 2013	21st May 2013 08:25 AM by rvanelli	5	297	US Food and Drug Administration (FDA)
	Vendor (Supplier) Responsibility - Re: Quality Audits OccamMan started this discussion on 9th May 2013	16th May 2013 11:24 PM by OccamMan	5	379	US Medical Devices (21 CFR part 820)
	Testing data for Special 510k and contact person Jennifer27 started this discussion on 5th March 2013	14th May 2013 08:04 PM by Jennifer27	4	339	Other US Medical Device Regulation Topics

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