Other US Medical Device Regulation Topics

		The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > US Medical Device Regulations
Other US Medical Device Regulation Topics

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Rating Discussion Thread Title / Thread Starter	Last Post or Poll Vote	Replies	Views
CDRH Appeals Process - New FDA Guidance Document sreenu927 started this discussion on 16th May 2013	16th May 2013 09:24 PM by sreenu927	0	92
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	289
Domestic and International Medical Device IFU (Instructions for Use) MF3009 started this discussion on 8th May 2013	10th May 2013 10:20 AM by ScottK	3	200
Proposed reclassification of Ultraviolet (UV) Lamps intended to tan the skin Ronen E started this discussion on 10th May 2013	10th May 2013 09:53 AM by Ronen E	0	105
Labeling Contraindication vs. Clinical Trial Exclusion Criterion --Jen-- started this discussion on 19th August 2011	8th May 2013 10:27 AM by polish10	7	908
Regulatory Approval for "Research Use Only" Medical Devices ( 1 2) divyaganapathy started this discussion on 18th July 2011	6th May 2013 06:19 PM by Ronen E	9	1,221
In 510k application do we submit documents showing compliance with 21CFRPart820 regmeddevices started this discussion on 11th June 2011	29th April 2013 07:52 PM by Ronen E	7	882
J&J's licence for cosmetics at Mulund plant (Mumbai, India) cancelled Ajit Basrur started this discussion on 27th April 2013	27th April 2013 02:46 PM by Ajit Basrur	0	257
Question re: Class II Medical Device Software - Label / Device Definition WP_Regulatory started this discussion on 19th April 2013	22nd April 2013 04:24 PM by WP_Regulatory	4	267
Who is responsible for cleaning medical devices before return for repairs? ( 1 2) Bunny started this discussion on 8th February 2011	18th April 2013 08:11 PM by Bunny	12	1,093
Need help in adding second location to FDA Registration Bunny started this discussion on 10th April 2013	15th April 2013 11:26 AM by Bunny	4	260
Guidance Document - Medical Device Classification Product Codes Ajit Basrur started this discussion on 13th April 2013	13th April 2013 10:37 PM by Ronen E	1	218
FDA - New Establishment Registration and Device Listing Requirements ( 1 2) bblbbblb started this discussion on 31st October 2012	11th April 2013 10:19 AM by Chrisx	13	1,180
Ideas on QA/RA Company Magazine SGquality started this discussion on 3rd April 2013	4th April 2013 08:23 PM by Jennifer Kirley	4	287
New Establishment Registration and Device Listing Rule - August 2012 ( 1 2 3 4 5) Ronen E started this discussion on 11th August 2012	1st April 2013 03:04 AM by sreenu927	32	2,468
510(k) Submission for a huge, changing complex Medical Device System wangyang started this discussion on 18th November 2012	26th March 2013 01:31 AM by Ronen E	4	462
New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Reporting ( 1 2) sreenu927 started this discussion on 25th February 2013	5th March 2013 11:28 PM by sreenu927	10	558
FDA eCopy Guidance for Comments isoalchemist started this discussion on 22nd October 2012	20th February 2013 03:25 AM by Pads38	3	534
FDA Submission Printing Format - Is double sided printing allowed? murena started this discussion on 5th November 2012	18th February 2013 04:51 PM by murena	5	574
Minimum Testing Requirements for a Clear Protective Equipment Barrier (Class II 510K) apriljoyc started this discussion on 8th February 2013	12th February 2013 08:30 PM by Stijloor	1	280

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