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
M Can you import medical device not FDA approved into the USA under an IND application? US Food and Drug Administration (FDA) 2
Ed Panek FDA Submits to White House Plan to Harmonize with ISO 13485 US Medical Device Regulations 0
Melissa Contract Mfg--to Manufacturer with the FDA ISO 13485:2016 - Medical Device Quality Management Systems 4
Ed Panek ANNUAL FDA Registration - What 510(k) number to use? US Food and Drug Administration (FDA) 1
Y FDA vs (EU) 2021/2226 Electronic Instructions for Use (eIFUs) US Medical Device Regulations 1
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JesseE Electronic signatures FDA CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 3
C FDA logo for marketing US Food and Drug Administration (FDA) 3
G FDA clearance for a device that can't be used clinically (at present) Other US Medical Device Regulations 5
M FDA Syringe Marking requirements US Food and Drug Administration (FDA) 4
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B When FDA Decision Summary opens? US Food and Drug Administration (FDA) 4
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
B How to submit Pre-submission to FDA? US Food and Drug Administration (FDA) 4
L FDA & 21 CFR Part 11 Medical Device and FDA Regulations and Standards News 19
B A.I. diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 6
Ed Panek 2020 FDA Top Ten Observations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B FDA Breakthrough Device can be overlapped with a designated device? US Food and Drug Administration (FDA) 6
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 5
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
Watchcat FDA vs NB Fees? Other US Medical Device Regulations 7
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4
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

Similar threads

Top Bottom