SBS - The best value in QMS software

FDA definition of a complaint - Customer orders spare parts

jkc3usc

Involved In Discussions
#1
FDA definition - electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance

Key word alleges.

Class II reusable devices

If my company receives a fax order or a call for parts from a costumer with no allegation of a deficiency would you considered this a complaint?
Would the need to ask more questions to dig be required?

Or would this all depend on the risk of the part and life expectancy of the part.
 
Elsmar Forum Sponsor

Ron Rompen

Trusted Information Resource
#2
perhaps I'm not clearly understanding the issue here, but what you have described sounds like a regular purchase. If there is no allegation of deficiency then I don't see how it could be considered a complaint.
 

jkc3usc

Involved In Discussions
#3
is what I am thinking as well. I don't need to assume the customer is ordering the part due to a malfunction? or problem?

Would the need to ask further questions be needed. I just see that leading to a definite complaint.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
As the manufacturer of the device, I believe, you would want to know as much as possible about your product performance.

If a component has an expected MTBF of 2 years and you see customers re-ordering the part every 3 months, wouldn't you want to know if the data shows a risk? Maybe the component needs re-engineering to enhance durability.

If the case in question is a one-off, I wouldn't be overly concerned, but I would start a tracking mechanism for replacement orders and see if there are any trends that could put the product durability and reliability in question.
 

jkc3usc

Involved In Discussions
#5
Thanks and I agree MTBF should be tracked. I just wasn't sure about coding it as a complaint.

Getting a fax order PO for example 40 fuses, hoses, etc without an allegation of any deficiency. Would the need to follow up and ask more questions be something the FDA would want. Or is filling the order and not documenting as a complaint sufficient.

Sorry for all the questions

thanks
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
A parts replacement order should not be coded as a complaint, in my estimation, assuming you have NO OTHER indication of unexpected failures for these parts. If there were, I would follow up with a call to customer to ascertain exactly why they are ordering it. As customer feedback about product performance is rare, that would give your organization a chance of interacting with the customer about their perception of the product performance in the field.
 
Thread starter Similar threads Forum Replies Date
H Customer Complaint - FDA Definition of Complaint Other US Medical Device Regulations 9
Z Definition Complaint - The FDA's definition of Complaint Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Definition User Needs - Concrete definition for "User Needs" as required by the FDA Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
S Definition Medical Device Accessory - FDA Definition of Accessory Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
R FDA Definition of "Raw Material" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
A "GMP Area" - FDA definition Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
S FDA Device Listing Question - "Each Device" Definition - 21 CFR Part 807 Other US Medical Device Regulations 4
D FDA Days - What is the FDA definition of FDA Days 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
AnaMariaVR2 Definition Test Site vs. Test Facility - FDA definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
M Risk Management in an FDA Context - Extended definition of "harm" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
M Do Package Inserts Meet the FDA Definition of Cut Labeling? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
L Definition Bench Test - Definition (in FDA context) and its difference with Clinical Study? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
C Definition Finished Medical Device - Definition of - FDA 21 CFR Part 820.1 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 13
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 4
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 2
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
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
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 3
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 6
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Watchcat FDA Webinar Series - N95 Respirators Other US Medical Device Regulations 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3

Similar threads

Top Bottom