Is Bench or Clinical testing better?

J

Jennifer27

#1
Dear Experts,

We are a medical device company that creates a wide variety of device. Currently, we are working on a blood glucose meter which is an IVD.

We are going to perform bench testing of our meter to verify the meter's repeatability, reproducibility, accuracy etc. This testing will be submitted to the FDA.

To obtain blood samples for testing, we have two options:

1. We collaborate with hospitals who will provide us with blood samples of diabetic and hypoglycaemic patients.
2. We create our own diabetic and hypoglycaemic samples, by adding some amount of glucose in blood taken from us.

I have two questions:
1. Which of the above you think is a better way to go about testing?
2. If we decide to take blood samples from the hospital, then do we need to comply with GCP, do we need to get informed consent forms, and get IRB approval of protocols?
We consider this as bench testing and not clinical testing, but what are your thoughts, should we comply with GCP?

Thank you so much!
Eagerly waiting for your response,
Regards,
Jen:thanks:
 
Elsmar Forum Sponsor
M

mogluk

#2
yes to use actual blood samples, you will need to comply with IRB requirements. And you should be conforming to GCP and cGMP for your product.

use of artificial samples can be used. Be prepared for greater scrutiny on your samples and their preparation (3rd party verification sample contents).
 
J

Jennifer27

#3
Thank you Mogluk! Yes you are right if we do artificial samples then yes more scrutiny from the FDA. Thanks a lot for your help.
 
Thread starter Similar threads Forum Replies Date
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
L Clinical Investigation vs. Bench Test - Definition EU Medical Device Regulations 1
L Definition Bench Test - Definition (in FDA context) and its difference with Clinical Study? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
Kuldeep Singh Mammography Machine Bench Testing - FDA 510(K) US Food and Drug Administration (FDA) 5
Ronen E FDA News FDA issues guidance on bench testing in premarket submissions Other US Medical Device Regulations 0
H Frequency of shelf life/sterilization/bench studies conducted on a medical device Other Medical Device Related Standards 1
I Bench Testing & Pre-verification vs. Formal verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F ≥5 micron macroparticles measurement in Laminar Airflow (LAF) bench (ISO Class 5) Miscellaneous Environmental Standards and EMS Related Discussions 0
J US import requirements for bench testing without 510k Other US Medical Device Regulations 3
S Bench Marking Automated Data Collection Benchmarking 4
M Bench Testing Requirements for Class 3 devices EU Medical Device Regulations 4
M What is a Bench Test and how is it used? Reliability Analysis - Predictions, Testing and Standards 4
M What should be in an SOP for a Machine Operation - LAF Bench in our Clean Room ISO 13485:2016 - Medical Device Quality Management Systems 3
N Critical Analysis of Medical Device Bench Testing data ISO 13485:2016 - Medical Device Quality Management Systems 6
D Aircraft Coffee Maker Repair Bench Glassware Calibration General Measurement Device and Calibration Topics 7
B Technical File Part A - Bench Testing CE Marking (Conformité Européene) / CB Scheme 3
D Do Device Verification Bench Tests need to be GLP? US Food and Drug Administration (FDA) 7
shimonv Bench Testing as part of 510(k) Submission US Food and Drug Administration (FDA) 1
O Which role plays Inverse cdf of a Standard Normal Distribution in Formula for Z-Bench Using Minitab Software 8
A Does the V&V (Verification and Validation) belong to Bench Testing for 510k? Qualification and Validation (including 21 CFR Part 11) 2
J Any Difference Between Bench Top and Portable Hardness Tester? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
Le Chiffre 510(k) Changes: More bench testing and stricter design controls? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Building a Calibration Room Test Bench - Finding components, test leads, etc. General Measurement Device and Calibration Topics 8
R How to determine magnification power? Illuminated bench-mounted magnifiers Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
N Bench Top Oven Calibration Standards General Measurement Device and Calibration Topics 8
L Can we use the data in intertek or TUV lab testing report as bench testing data? Other US Medical Device Regulations 2
T Installation Requirements for Bench Top Device ISO 13485:2016 - Medical Device Quality Management Systems 1
A How to Determine ESD mat dimensions for work bench? Misc. Quality Assurance and Business Systems Related Topics 7
R Bench Marking in Construction Industry - Seeking Guidelines Benchmarking 8
J Does anyone know how to adjust/calibrate bench centers that are not parallel? General Measurement Device and Calibration Topics 4
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
M Clinical Development Plan - Advice Requested EU Medical Device Regulations 8
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
dgrainger Informational MDCG 2020:13 - Clinical evaluation assessment report template EU Medical Device Regulations 0
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
C MDCG 2020-06 Clinical evidence legacy devices EU Medical Device Regulations 3
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 6
M Clinical Evaluation Plan vs. PMCF Plan EU Medical Device Regulations 19
S Selling Clinical Practice Advice Other US Medical Device Regulations 7
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
M Good Clinical Practice (GCP) - ISO 14155 vs. ICH Other ISO and International Standards and European Regulations 10
S Article 61 - MDR Clinical Investigation Requirement EU Medical Device Regulations 5
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 2
R Do Medical Device Complaints include Clinical Trials? Medical Device and FDA Regulations and Standards News 3
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 12

Similar threads

Top Bottom