When is a system not a single device? Does anybody know of a guidance document?

Al Rosen

Staff member
Super Moderator
#11
Re: When is a system not a single device?

jewels said:
Yes, I know. The statement received was:

"the "kits" do not have the same intended use. Therefore, we cannot list both of them on the same license." The intended use was very similar and still they did not consider them the same device.

I did challenge it and the outcome was to list them on 2 licenses.

That's why my previous comment was to ask the agencies what they will expect to avoid delay in getting the license accepted.
How long ago did you submit this to FDA?
 
Elsmar Forum Sponsor
M

Medevice

#12
Re: When is a system not a single device?

Al Rosen said:
Steve, this is the only document I've seen. I don't know if it addresses your concerns. Let me know what you think.
Thanks Al.

Its an interesting doc, but not quite what I was looking for. Looks like the issue I have is in the "rarely seen" tray. Time to get a good argument together just in case ...

jewels said:
It seems that is up to the reviewer of the application.
Indeed it does. :rolleyes:

Thanks all.
Steve.
 
Thread starter Similar threads Forum Replies Date
M Integrating Multiple HSEQ Systems into a Single Harmonised Global System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Combine ISO 9001 and AS9100 into a single Quality Manual and System? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Single Fault Condition for 3-Phase Medical System - IEC 60601 Clause 8.1b IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Ford BSAQ (Balanced Single Agenda for Quality) System questions Customer and Company Specific Requirements 6
A Packaging Commercial off-the-shelf (COTS) Products as a Single System Design and Development of Products and Processes 2
J Single Flow Chart for Multiple System Procedures Process Maps, Process Mapping and Turtle Diagrams 7
xfngrs Integrating ISO 14001 with QS-9000 for a 'single' system Miscellaneous Environmental Standards and EMS Related Discussions 4
G Integration of ISO 14001 with ISO 9001 for a 'single' system Miscellaneous Environmental Standards and EMS Related Discussions 24
T Device & Accessory, Components in device, or System EU Medical Device Regulations 0
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
John C. Abnet Terms- Different Items in a system ISO 26262 - Road vehicles – Functional safety 0
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
G Management Review (integrated system) Management Review Meetings and related Processes 17
M Unique Quality Management System for 2 sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Orthopedic Implants (Knee system) Sterilization Indicators Manufacturing and Related Processes 6
C Projects in the CAPA system Preventive Action and Continuous Improvement 6
E Insulation diagram for ECG monitoring and diagnosis system. IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
J Mastercontrol or other system ISO 13485:2016 - Medical Device Quality Management Systems 0
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 MSA - what exactly mean "system" and master sample Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
P MSA study for visual system with artifical inteligence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D Big companies suffer from quality management system? ISO 13485:2016 - Medical Device Quality Management Systems 1
qualprod Assign a name to a home-made ERP system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Biological indicator system classification under MDR EU Medical Device Regulations 2
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R How would you work without a quality management system? IATF 16949 - Automotive Quality Systems Standard 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
D EQMS - When the internet or system might not be available ISO 13485:2016 - Medical Device Quality Management Systems 7
Ron Rompen MSA on automated measurement system - Multiple Step Vision System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S Quality management system (Well head installation & maintenance) Quality Management System (QMS) Manuals 5
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
P How to develop executable quality management system for rookies? IATF 16949 - Automotive Quality Systems Standard 9
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
G IMS (Integrated Management System) 9001, 14001 & 45001- Request Assistance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
R SAT (System Accuracy Test) temperature according to AMS2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Building up a global quality management system ISO 13485:2016 - Medical Device Quality Management Systems 2
A Building up a global quality management system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
H Pedicle screw system Conformity Assessment Other Medical Device Related Standards 2
S Rees System Validation Qualification and Validation (including 21 CFR Part 11) 1
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
C NCR (Nonconformance System) Software Nonconformance and Corrective Action 7

Similar threads

Top Bottom