Laminating abbreviated Operators Manual to IFU's and DFU's

M

MDDRegAffairs

#1
Dear all,

After receiving user feedback on a currently 510(k) cleared device we are investigating the option of affixing a laminated abbreviated operators manual to the device. Currently, neither the operators manual or directions for use are laminated. The device is used while the patient is admitted and lying in a bed and can be moved from room to room for use with multiple patients. My uncertainties are:

1. What if any regulatory requirements are associated with lamenting the operators manual and directions for use (i.e., abbreviated 510(k))?

2.1 Are any new risks introduced by attaching an abbreviated operators manual to the device?

2.2 If yes, how can these risks be mitigated (i.e., disclaimers)?

Any comments would be greatly appreciated,

Regards,

Tom
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Dear all,

After receiving user feedback on a currently 510(k) cleared device we are investigating the option of affixing a laminated abbreviated operators manual to the device. Currently, neither the operators manual or directions for use are laminated. The device is used while the patient is admitted and lying in a bed and can be moved from room to room for use with multiple patients. My uncertainties are:

1. What if any regulatory requirements are associated with lamenting the operators manual and directions for use (i.e., abbreviated 510(k))?

2.1 Are any new risks introduced by attaching an abbreviated operators manual to the device?

2.2 If yes, how can these risks be mitigated (i.e., disclaimers)?

Any comments would be greatly appreciated,

Regards,

Tom
1. It's your responsibility to investigate and identify any such requirements, and comply.

2.1 Yes.

2.2 Run a documented risk management session, decide and implement as required.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S The key differences in 510k types - Traditional vs. Abbreviated vs. Special US Food and Drug Administration (FDA) 0
Q FDA:Expansion of the Abbreviated 510(k) 2 Program 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Oscar Wang Question on the Content of an Abbreviated 510(k) US Food and Drug Administration (FDA) 1
R Why not use abbreviated 510k submissions? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L What is the difference between Traditional and Abbreviated 510(K) application ? Other Medical Device and Orthopedic Related Topics 3
N Telephone Amendment to Abbreviated New Drug Applications (ANDA) US Food and Drug Administration (FDA) 1
E Do I need submit a traditional 510(k) or Abbreviated 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
S Abbreviated Quality System for Corporate Sales Office? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C ANDA (Abbreviated New Drug Application) Filing - Ophthalmic Solution Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
Marc Definition Quality Assurance - An Abbreviated History Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
Marc TL 9000 Release 3.0 - An abbreviated transition for TL 9000 - Changes and Additions TL 9000 Telecommunications Standard and QuEST 1
C Quantifying risk in choosing the number of parts, operators and replicates in a GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
Z Economic Operators Responsibilities after DOA for legacy MDD devices EU Medical Device Regulations 2
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
J Informational Gage R&R: Swapping operators Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
S Hourly Registration training for operators Manufacturing and Related Processes 1
B Variable Gage R&R - Two operators instead of three Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
W GR&R (two dimensions on a shaft) with few parts and only 2 operators Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
M 10 parts, 3 operators, 3 measurements GR&R study tolerance question Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
Miner Advanced MSA of Continuous Data Part 3: Are 3 Operators or 2 Replicates Enough? Imported Legacy Blogs 0
Mikey324 Testing Methods to Qualify Operators (Measuring Devices) Capability, Accuracy and Stability - Processes, Machines, etc. 4
L Quick way to check spline pitch runout for machine operators Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
J Attribute Data MSA for more than 3 Operators Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
K Production Operators Performing GP12 (General Motors Containment) Customer and Company Specific Requirements 2
L ESD Protection and Danger for Operators Manufacturing and Related Processes 3
C Constructing an AQL matrix for our QC operators in a flexographic printing outfit AQL - Acceptable Quality Level 4
R KPIs (Key Performance Indicators) for Telecom Operators TL 9000 Telecommunications Standard and QuEST 1
A Gage R&R without Operators (using Sensors) using Minitab Using Minitab Software 2
S Anova Gage R&R Calculations for 4 Operators Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Clean Room Training for Manufacturing Operators (Personal Hygiene, Gowning, etc.) Other Medical Device and Orthopedic Related Topics 4
M How to Manage Employees (Operators) - Training for specific Jobs Manufacturing and Related Processes 4
K How to Communicate to Operators (Especially Foreign Workers) - Language Issues Misc. Quality Assurance and Business Systems Related Topics 11
G Training Method for Trainers of Operators Training - Internal, External, Online and Distance Learning 9
Hami812 Gage R&R Process Method - Pass/Fail Criteria Offered to Operators vs. Parametric Data Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
K Electronic Work Instructions for the Operators during Assembly Work Document Control Systems, Procedures, Forms and Templates 7
R ISO Audit Relevance Questions - Equipment Operators ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Rotating operators through experiencing Inspection - A real eye opener... Training - Internal, External, Online and Distance Learning 6
J Gage R&R - Sensor Tester with Multiple Operators and Multiple Sensor Test Channels Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
C Interpreting Gage R&R Results - 3 operators, 3 iterations and 10 parts Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
L Quality Table Top Exercise - ISO9001 Awareness Training to the operators Training - Internal, External, Online and Distance Learning 13
P Is Blaming Operators for Nonconformances correct? Quality Manager and Management Related Issues 62
Ajit Basrur How to Improve Quality Consciousness of Operators? Training - Internal, External, Online and Distance Learning 30
T Gage R & R Study "Best Practices" - More than three operators? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
V Competency - How I can show experienced operators are competent? Document Control Systems, Procedures, Forms and Templates 3
Ajit Basrur Driving License for Forklift operators Manufacturing and Related Processes 9
C Standard Operating Procedures (SOP) for CATV operators - Example wanted TL 9000 Telecommunications Standard and QuEST 2
8 SMED Classroom Exercise to show operators the importance of SMED Lean in Manufacturing and Service Industries 10
P MSA (Measurement Systems Analysis) Gage R&R with 10 Operators Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
Similar threads


















































Top Bottom