Help me understand the applicability of 21 CFR Part 820.198 (Customer Complaints)

Aphel

Involved In Discussions
#1
Hello!

Actually I have to deal with discussions regarding correct complaint handling...

Therefore I would need your opinion, regarding an interpretation of ?820.198. First I will explain the situation...

The company (legal manufacturer) is selling prosthesis products (medical devices) to the customer. In this case the customer is not the "device user" or the patient, the customer is a prosthetist, who adjusts our device for the device user or patient.
This prosthetist also uses spare parts (e.g. screws,...) from our company for preparing the device. He buys these spare parts from our warehouse.

From my point of view, chapter 820.198 is applicable for medical devices and not for spare parts for these devices.
Here is my question.

According to your opinion - if the prosthetist buys a new screw from us (legal manufacturer) and this screw breaks during the prosthetist is fitting the device for the patient...the prosthetist notifies us of this event...are we talking about a complaint acc. ?820.198 in this case?

Thank you very much for your support and feedback!

Best regards,
Aphel
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
According to your opinion - if the prosthetist buys a new screw from us (legal manufacturer) and this screw breaks during the prosthetist is fitting the device for the patient...the prosthetist notifies us of this event...are we talking about a complaint acc. ?820.198 in this case?
Against the FDA definition of complaint
(b)Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
it seems that, without a question, the scenario offered should be handled as a complaint.
 

Aphel

Involved In Discussions
#3
The FDA definition contains the term "device"...

So, if we are talking about spare parts in my example, I have to treat them like a device?

Best regards,
Aphel
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
What is a medical device?
A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
 
Thread starter Similar threads Forum Replies Date
Ajit Basrur Need help to understand HIPAA requirements ISO 13485:2016 - Medical Device Quality Management Systems 17
J Please help me understand what a process is ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Help me understand how to conduct a Chi Square Test Statistical Analysis Tools, Techniques and SPC 3
S Informational Please help this newbie understand ISO 9001 Work Instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 44
F Help me understand the ANOVA Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Kindly help me to understand MSA Acceptance Level Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
T Help me understand how to define Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
N Help me understand the ISO section 7.5.2 from API Q1 perspective Oil and Gas Industry Standards and Regulations 4
A Help Engineers understand the differences between Bill of Materials and Routers Document Control Systems, Procedures, Forms and Templates 9
G Numbers that will help us understand what the Cost of Rework is Misc. Quality Assurance and Business Systems Related Topics 7
G Newbie in IMDS - Please help me understand what I have to do RoHS, REACH, ELV, IMDS and Restricted Substances 4
B ISO 9001:2008 - Can any one help me to understand this paragraph? Clause 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
R Please help us to understand clause 5.5.2 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Can Someone help me to understand....... Imported Legacy Blogs 3
M Anyone can help me to understand basics of 6 sigma Six Sigma 1
A Hypergeometric Distribution - Help needed to understand Statistical Analysis Tools, Techniques and SPC 11
S Can someone help me to understand GR&R (Gage R&R) analysis methods? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Statistics for Dummies - Book, class, or tutorial to help me understand Statistical Analysis Tools, Techniques and SPC 5
R Lead auditor scenario (Need help) is this non conforming to ISO13485 Manufacturing and Related Processes 2
J HELP NEEDED ! Risk Management Exercise ISO 14971 - Medical Device Risk Management 12
D Help Me. Non conformitty in External Audit IATF 16949 - Automotive Quality Systems Standard 13
U Need Help With API Q2 Quality Manual Oil and Gas Industry Standards and Regulations 8
A Nonconformity help IATF 16949 - Automotive Quality Systems Standard 5
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Azaarus Help with CAPA for an IATF finding regarding inspection documentation IATF 16949 - Automotive Quality Systems Standard 10
A Help needed with locating conector Design and Development of Products and Processes 0
Y CER: can "state of the art" help to make up for literature search on equivalant devices? EU Medical Device Regulations 1
D Need some Help on 8D fault tree analysis Problem Solving, Root Cause Fault and Failure Analysis 6
B Can someone help me explain P-Value with a simple word please? Capability, Accuracy and Stability - Processes, Machines, etc. 11
M Help on formulating a LP minimization problem Manufacturing and Related Processes 2
N Help with understanding Process Controls Manufacturing and Related Processes 7
K Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
S Need help with analysing a survey on minitab Using Minitab Software 1

Similar threads

Top Bottom