SBS - The best value in QMS software

Regulations for Medical Device Kit for Training Personnel?

Q

QualityDean

Registered
#1
#1
My company is designing a training kit whereas all products inside the kit are labeled "Not for medical use." What is our FDA Design Control requirements for this type of kit? It will be marketed and sold to end user who will only be using the kit for training purposes.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
This is likely to be considered "not a medical device", which would make it exempt from all medical devices regulations.

- I would consider changing "medical use" to "clinical use", as the former is a bit more vague. Training medical personnel might be considered a medical use. Clinical use means use for treating (etc.) human patients.

- Intended use (which is what the FDA considers when ruling whether something is a medical device or not) is not determined solely by labeling, so make sure that your org's entire conduct (including sales force verbal statements, website contents etc.) supports a conclusion/impression that no clinical use is intended.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 10
J Medical device related standards or regulations - Disposed records log ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Interpreting China Medical Device regulations/standards China Medical Device Regulations 1
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
D Documentation requirements for the new Medical Device Regulations (2019) CE Marking (Conformité Européene) / CB Scheme 5
N Per the FDA regulations can a medical device be class I despite that it is sterile? Other Medical Device Related Standards 4
J What are a Taiwanese Medical device subcontractor's legal responsibilities with Taiwan regulations? Other Medical Device Regulations World-Wide 2
M Medical Device Regulations in African Countries Other Medical Device Regulations World-Wide 0
R How to keep track of all FDA rules and regulations for medical device companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Applicable Medical Device Wifi regulations for various Countries Other Medical Device Regulations World-Wide 7
C "Fast action" claim and MDR (Medical Device Regulations) EU Medical Device Regulations 8
T Research Medical Device EU - Requirements and Regulations EU Medical Device Regulations 13
H EU Medical Device Regulations (MDR) Checklist EU Medical Device Regulations 1
C Where to buy the latest MHLW, Canada MDR, Brazil medical device regulations Other Medical Device Regulations World-Wide 2
S MDR (Medical Device Regulations 2017/745) training recommendation for Auditors EU Medical Device Regulations 1
M FDA Considers Shift on Medical Device Quality System Regulations - 2018 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
F India Medical Device Regulations - Update - 2017 Other Medical Device Regulations World-Wide 11
N New MDR EU Medical Device/IVD Regulations - Definition of Importer EU Medical Device Regulations 1
S Final Medical Device Regulations replacing MDD 93/42/EEC, etc. EU Medical Device Regulations 15
K Medical Device Regulations in South Africa - Company makes thousands of Products Other Medical Device Regulations World-Wide 1
G Medical Device Regulations in Chile Other Medical Device Regulations World-Wide 1
Q Looking for Cross Functional Matrix of Medical Device Regulations around the World Other Medical Device Regulations World-Wide 5
T New EU Medical Device Regulations - Q1/2 2017 and Human Factors Other Medical Device Related Standards 10
Q Efficient way to manage different country Medical Device Regulations Other US Medical Device Regulations 10
S 'Clean' Draft Medical Device Regulations Published EU Medical Device Regulations 0
G How to place a medical device in Switzerland (Regulations) Other Medical Device Regulations World-Wide 4
M Updates on proposed EU Medical Device Regulations - June 2016 EU Medical Device Regulations 20
L Malaysia Medical device regulations June 2016 Other Medical Device Regulations World-Wide 3
rob73 New MDD (European Medical Device Regulations) next steps - 2016 EU Medical Device Regulations 1
S Please recommend any good training courses for Medical Device Regulations Training - Internal, External, Online and Distance Learning 8
P For medical device regulations in India, do I follow CDSCO or BIS ? Other Medical Device Regulations World-Wide 1
P Russian Medical Device Regulations for Multiple Brands of the same Product Other Medical Device Regulations World-Wide 4
E Republic Of Georgia Medical Device Regulations for IVD Other Medical Device Regulations World-Wide 6
pittmatj Are New Brazil Class I Medical Device Regulations Expected? Other Medical Device Regulations World-Wide 10
M Guidance for Medical Device Registration in Med Dev Regulations World-Wide Other Medical Device Regulations World-Wide 24
pittmatj South Korea - Custom Medical Device Regulations Other Medical Device Regulations World-Wide 1
M Overview of European Regulations of Medical Device Other ISO and International Standards and European Regulations 12
K Harmonisation of Global Medical Device Pre-Market Regulations Other Medical Device Regulations World-Wide 5
M US FDA Medical Device Distributor Regulations US Food and Drug Administration (FDA) 4
P EU MDD revisions white paper on the proposals for the Medical Device Regulations EU Medical Device Regulations 1
Z Iraq Medical Device Regulations Other Medical Device Regulations World-Wide 7
A Which ERP system complies to medical device regulations? ISO 13485:2016 - Medical Device Quality Management Systems 4
M CMDR (Canadian Medical Device Regulations) Training Canada Medical Device Regulations 3
D Medical Device Regulations in Bermuda Other Medical Device Regulations World-Wide 6
L Medical Device Regulations in Morocco, Algeria, Tunisia Other Medical Device Regulations World-Wide 2

Similar threads

Top Bottom