SBS - The best value in QMS software

Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial

Tiffany88

Starting to get Involved
#1
Hi all,

I need your help again!
It is possible to use a medical device product not cleared (without FDA approval) in a drug trial.
We have a client that will perform a clinical trial and want to use our product (a software stand alone) to process the results of the trial but our product is not approved yet.
Thank you
 
Elsmar Forum Sponsor

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
No. One variable at a time. For an IDE or IND the only exception I have seen is using an approved device for off label use. For example, our surgeons in the surgical procedures wanted to use hemostats to help move a nerve into a position to wrap a cuff around it. Surgeons have some leeway in the way they are allowed to use tools in their protocols.

You first need to demonstrate singularly to the FDA your device is safe and effective for its claims.

Any IRB would suggest high risk and thus FDA oversight.

I worked at the Dept Veterans Affairs and managed several IDE studies. Almost every PhD had the IRB review require FDA oversight and a master file submitted to the FDA. They could consent a population to use a non approved drug but you cannot legally consent to also an unapproved device as well. This would require your own study to demonstrate effectiveness and safety before used in conjunction with the drug.
 
Last edited:

Watchcat

Trusted Information Resource
#4
Yes, it is possible to use a medical device not legally marketed in the US in a drug trial.

It is also possible to use one in a drug trial conducted at US sites.

If what you meant to ask is how do you legally conduct a clinical trial at US sites when that trial requires use of a device that is not legally marketed in the US, the answer is that you need to have an approved IDE.
 

Marcelo

Inactive Registered Visitor
#5
Hi all,

I need your help again!
It is possible to use a medical device product not cleared (without FDA approval) in a drug trial.
We have a client that will perform a clinical trial and want to use our product (a software stand alone) to process the results of the trial but our product is not approved yet.
Thank you
So, you mean that the device is a combination product and thus they would trial the device/drug? Or that it's a drug product, and for some reason they want the use the device?

The answers might be different depending on the situation (when I answered before, I was under the impressions that they were separate).
 
Last edited:

Watchcat

Trusted Information Resource
#6
For an IDE or IND the only exception I have seen is using an approved device for off label use. For example, our surgeons in the surgical procedures wanted to use hemostats to help move a nerve into a position to wrap a cuff around it. Surgeons have some leeway in the way they are allowed to use tools in their protocols.
If it was the surgeons who wanted to do it this way, instead of the sponsor wanting them to do it, I don't know that I'd call this an exception to the IDE, maybe more like outside of its scope. But maybe you are talking about a sponsor-investigator? (You say "their" protocols?)

Any IRB would suggest high risk and thus FDA oversight.
I'm afraid "any IRB" is something of a stretch. :( But I don't think IRBs would need to worry about the risk, since, as far as I know, there is no NSR exemption from the IND regulations? In that case, since the drug is also investigational, the study would require FDA oversight regardless of the level of risk of the device, don't you think?

I worked at the Dept Veterans Affairs and managed several IDE studies. Almost every PhD had the IRB review require FDA oversight and a master file submitted to the FDA.
I've worked with federally funded trials, sponsored by federally funded organizations. I think they tend to hold themselves to somewhat different standards than are typically found in the industry. They may also operate under various policy and/or legal constraints that are not applicable to trials sponsored by industry.

You first need to demonstrate singularly to the FDA your device is safe and effective for its claims.
You mean before using it in a trial? I wouldn't think so. That's what you need to demonstrate in order to market it.

They could consent a population to use a non approved drug but you cannot legally consent to also an unapproved device as well.
I'm not aware of this prohibition. Is it part of the FD&C Act, or some other law?
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#7
You make some good points. My work in Cleveland was mostly around nerve cuff and muscle stim for amputees and exoskeletons for SCI. Also all of our studies required a master file approval and FDA IDE rules.

Surgeons meet with the investigators and create a surgery "plan". How they plan to implant or explant the device. Just because a tool doesnt exist to hold a nerve in place to wrap a cuff around it doesnt mean the surgeon cant plan to use any other to perform that function. But the plan must be reviewable.
 
Last edited:

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#9
Oh like bringing their cell phones (Unsterilized) into the OR and taking selfies with the patient? :)
 
Thread starter Similar threads Forum Replies Date
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
T Medical device Clinical trial exemption list China Medical Device Regulations 2
M Does Medical Device Usability Study = Clinical Trial? Other Medical Device and Orthopedic Related Topics 26
A Singapore - Requirements for Import of Medical Devices for Clinical Trial Other Medical Device Regulations World-Wide 2
I Medical Device Clinical Trial Audit Checklist wanted ISO 13485:2016 - Medical Device Quality Management Systems 2
S Roadmap for Clinical Trial for Orthopaedic Medical Devices EU Medical Device Regulations 2
P Medical Device Clinical Trial Labels Other Medical Device and Orthopedic Related Topics 3
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
F China Device Assisted Technology Clinical Trial China Medical Device Regulations 4
R Clinical Trial to sell in the EU - Necessary or Not? ISO 13485:2016 - Medical Device Quality Management Systems 5
J Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
H IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
Q South Africa Clinical Trial Inspections by MCC Quality Manager and Management Related Issues 1
S Clinical Trial Informed Consent Forms ("retro-signing") US Food and Drug Administration (FDA) 2
B Health Canada Acceptance Policy of Foreign Clinical Trial Data for Devices Canada Medical Device Regulations 2
C Retention of Clinical Trial Data after a Clinical Trial has ended Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
N Can a Clinical Trial Lead Investigator Surgeon be a Expert Clinical Evaluator? ISO 13485:2016 - Medical Device Quality Management Systems 3
R CE Mark requirements on US Clinical Trial Product CE Marking (Conformité Européene) / CB Scheme 2
I IVD product for use in a Drug Clinical Trial (FDA matters) US Food and Drug Administration (FDA) 3
J Labeling Contraindication vs. Clinical Trial Exclusion Criterion Other US Medical Device Regulations 7
bio_subbu CDSCO issues Draft Guidelines for Approval of Clinical Trial & New Drugs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D EU Clinical Trial Startup vs. US IDE (Investigational Device Exemption) ISO 13485:2016 - Medical Device Quality Management Systems 1
S Clinical Trial Study Reports - SOP Other US Medical Device Regulations 3
N Requirement of GCP for a clinical trial of IVD EU Medical Device Regulations 5
K Does a Radiotherapy device need a clinical trial for getting registered in China? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
P GSPRs / Clinical Evaluation EU Medical Device Regulations 3
P IDEs and Clinical Investigators - Advice About Records? Other US Medical Device Regulations 3
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 6
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Regular updates of clinical evaluation report EU Medical Device Regulations 6
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
R Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO Other Medical Device Related Standards 11
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
M Clinical Evaluation Benchmark vs. Equivalent EU Medical Device Regulations 2
D Classification of product for clinical trials EU Medical Device Regulations 14
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
S Australia TGA Clinical Evaluation Report (CER) Other Medical Device Regulations World-Wide 0
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
E Use of OQ cleared batch for stability and clinical study use ISO 13485:2016 - Medical Device Quality Management Systems 0
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
M Clinical Development Plan - Advice Requested EU Medical Device Regulations 11
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

Similar threads

Top Bottom