SBS - The best value in QMS software

FDA wants electrical safety testing on battery powered medical device

J

Jimbo

Registered
#11
#11
Aki K said:
Hi Jimbo,

Did you or NTS test all the relevant cases from 60601-1 subclause 8.4? For examble the patient auxiliary current? I have seen some cases when this is ignored totally (for internally powered devices) even though the standard clearly says the compliance is checked by mesurement (according to 8.7.4).

br Aki
Click to expand...
Good point Aki. We did. Aux current AKA touch current in a battery device was tested and as you would expect was below safe levels. This was included in our submission. We pointed the reviewer to it and I think he didn't know what it meant. He could not get his head turned to the thought that we were submitting for a battery powered device and he clearly didn't know that MAINS issues did not apply. The good news is that I went over his head to a more knowledgeable person and solved the problem. Vindication with the FDA is a "sweet" thing.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Ed Panek Other company wants to use our FDA 510K bundled with their product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A What to expect if FDA wants to inspect a Class 1 Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 5
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 3
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
K FDA - Can we have more than 1 Initial Importer Medical Device and FDA Regulations and Standards News 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 12
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
P Choice of FDA reviewer US Food and Drug Administration (FDA) 6
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 8
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 8

Similar threads

Top Bottom