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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Other US Medical Device Regulation Topics - Discussion Threads

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Rating Discussion Thread Title / Thread Starter	Last Post or Poll Vote	Replies	Views
Is a new 510(k) needed? Add Non Medical Device into a Medical Device App ( 1 2) wangyang started this discussion on 7th May 2012	22nd May 2012 07:51 AM by Gert Sorensen	13	1,184
FDA distributes draft guidance related to X-ray Imaging Device 510(k)s Ronen E started this discussion on 10th May 2012	11th May 2012 06:01 AM by Stijloor	1	386
Submission of foreign data without IRB approval zmimshen started this discussion on 24th April 2012	26th April 2012 07:11 AM by Marc	2	403
Aeration Room Requirements for EtO Sterilization Arnthor started this discussion on 23rd April 2012	24th April 2012 02:17 AM by Ronen E	2	594
Foreign Manufacturer selling in the US - Postmarket Surveillance question zmimshen started this discussion on 19th April 2012	19th April 2012 03:46 PM by zmimshen	2	410
Medical Device Wireless Labeling Requirements jessglud started this discussion on 11th April 2011	17th April 2012 03:48 AM by wangyang	3	857
Does a US FDA Class I (exempt) device require a Statement of Intended Use? Bunny started this discussion on 13th April 2012	13th April 2012 03:50 PM by MIREGMGR	3	453
FDA Device Listing Question - "Each Device" Definition - 21 CFR Part 807 singber started this discussion on 12th May 2011	12th April 2012 09:37 PM by wangyang	4	886
Suggestions for Selecting RF Wireless Components mr.mike started this discussion on 24th May 2011	12th April 2012 09:27 PM by wangyang	3	762
The predicated device with a different DXN (Medical Device Product Code) wangyang started this discussion on 11th April 2012	12th April 2012 09:20 PM by wangyang	4	469
Changing Critical Supplier: What are the requirements ( 1 2) ElmerF started this discussion on 10th April 2012	12th April 2012 06:13 PM by Ronen E	8	652
FDA Classification for Medical Device Power Adaptors (Power Supplies) ( 1 2) yarina started this discussion on 21st September 2011	10th April 2012 12:31 AM by Ronen E	12	1,298
Made in China - Requirement for it to be Printed on the Label? wangyang started this discussion on 5th April 2012	6th April 2012 01:46 AM by MIREGMGR	2	466
Marketing Class I Medical Devices before being listed in FURLS LievenDW started this discussion on 3rd April 2012	4th April 2012 03:35 AM by Ronen E	3	341
FDA Rules on Medical Device Classification Listings? ryno fan started this discussion on 30th March 2012	31st March 2012 10:20 AM by MIREGMGR	3	610
US Federal Regulation(s) on Wooden Pallets Arnthor started this discussion on 27th March 2012	27th March 2012 09:08 PM by Ajit Basrur	3	425
Market Withdrawal or a Removal? Replace product in the field with an improved version mrivera started this discussion on 26th May 2010	24th March 2012 10:40 AM by MIREGMGR	3	1,175
Is FCC required for Medical Equipment without Radio Frequency Energy? Roland chung started this discussion on 21st March 2012	22nd March 2012 01:18 AM by MIREGMGR	5	461
FDA Preapproval Inspection - Submitting a 505b2 for a combination product to the FDA wooden nickle started this discussion on 15th March 2012	19th March 2012 09:30 AM by wooden nickle	5	690
Class II Medical Device Refurbishment Requirements dwayneq started this discussion on 18th March 2012	19th March 2012 07:37 AM by rob73	2	440

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