SBS - The best value in QMS software

"RUO" (Research Use Only) Medical Device now seeking Clinic Use

R

Republiccafe

#1
#1
We have a medical device (Class I) registered for Research Use Only. Now we are using it in a general clinical setting. Should we seek another registration with FDA? Can the RUO registration and the clinic registration for the same device co-exist?

Thank you. :)
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
#2
Republiccafe said:
We have a medical device (Class I)...
Click to expand...
What is the nature of your device...an IVD or a device related to IVDs?

Given that the point of RUO status is to avoid classification and associated compliance requirements that apply to patient-diagnostic-use devices, how have you established that your device is Class I?

...registered for Research Use Only.
Click to expand...
What does "registered" refer to?

Now we are using it in a general clinical setting. Should we seek another registration with FDA? Can the RUO registration and the clinic registration for the same device co-exist?
Click to expand...
Generally, sales of a device labeled Research Use Only to a user that the seller knows or should know will make clinical use of the device, constitute misbranding and are illegal.

Guessing that your device may be an IVD, the relevant guidance is http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm253307.htm.
 
amjadrana

amjadrana

Involved - Posts
#3
#3
Can a medical device that is not an IVD be used for "Research use only"? Would it be a medical device according to accepted definition, if it is not to be used for investigational purposes for the evaluation of safety and effectiveness?
 
M

MIREGMGR

#4
#4
As I think you're referencing, Investigational Device Exemption status is somewhat parallel to Research Use Only status; the former being used for non-IVD devices, the latter for IVDs.

An IDE-status device is a qualified device per definition; it however is not legally marketable for, or usable in, non-IDE clinical applications.

The IDE and RUO terms crossover to each other to a certain extent. There is a version of the Certificate to Foreign Government process (Form 3613c) that pertains to devices to be used outside of the US for research use, which certifies that the device(s) in question are legally usable for research in the US, but are not legal for US non-research clinical applications and are not intended for outside-US non-research clinical applications.
 
amjadrana

amjadrana

Involved - Posts
#5
#5
Thanks MIREGMGR for your reply. Maybe I did not put my question clearly. Can a medical device be an investigational device for clinical evaluation with an intended use and at the same time be a RESEARCH ONLY use not for clinical investigation for safety or effectiveness but only for research without any intended use? If it is for RESEARCH use only, would it fall under the definition of medical device and would other regulations like IDE be applicabel at all?
 
M

MIREGMGR

#6
#6
A scenario to make sure I understand the question:

1. Our hypothetical device is classified and marketable for clinical use in Diagnosis or Treatment of Disease/Condition X.

2. The same device is RUO or IDE for restricted use in some other application, not involving patients except possibly in the context of a qualified, supervised research program.

I think the answer is, the same marketed device cannot have both uses because it would not be permissible to label it both ways. However, the same core product could be provided to the market as two different devices, each with labeling for one of the the above applications.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Medical Device Research Use Only (RUO) label Other Medical Device Regulations World-Wide 4
H Research Use Only (RUO) Medical Devices in China China Medical Device Regulations 7
H Medical Device RUO (Research Use Only) and 'Sterile' Label Claims 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Research Use Only (RUO) Medical Devices and FDA Registrar Corp 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q RUO (Research Use Only) vs. IVD (In Vitro Diagnostic) - Differences EU Medical Device Regulations 6
W Question on Research Use Only (RUO) products into Indonesia, Philippines and Thailand Other Medical Device Regulations World-Wide 2
J Research Use Only (RUO) for Non IVD in EU EU Medical Device Regulations 5
D RUO (Research Use Only - Laboratory Instrument) CE Marking Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V CE marking and RUO (Research Use Only) products - Distributing in vitro products EU Medical Device Regulations 6
J FDA Establishment Registration Foreign Manufacturer RUO only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Pre-clinical Studies for RUO Product Other Medical Device Regulations World-Wide 1
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
R RUO audits - CFR 820.22 and ISO 13485 8.2.4 Internal Auditing 3
M Use of RUO reagents in an LDT Quality Manager and Management Related Issues 2
S Distribution of IVD products for RUO and IUO-FDA Final Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R MDR Reporting for event with RUO instrument 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Freeze Drying Process Control for Antibodies (RUO and IVD) ISO 13485:2016 - Medical Device Quality Management Systems 1
M Reusing existing RUO Software for IVD Development 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Y Draft Guidance - IVD Products Labeled for RUO - FAQs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Can an IVD kit be used on RUO Instrument as per EU (and US) regulations? CE Marking (Conformité Européene) / CB Scheme 4
S Same computer for RUO and IVD - Same part number for 2 different IVDs EU Medical Device Regulations 2
S Any violation with the use of RUO software with IVD instrument CE Marking (Conformité Européene) / CB Scheme 3
S Single Medical Device Warranty card for both RUO and IVD!! ISO 13485:2016 - Medical Device Quality Management Systems 1
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
A VDmax25 and cGMP requirements for "research use only" products Other Medical Device Related Standards 1
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
M Exemption Clauses for Research, Demonstration, etc. Other Medical Device Regulations World-Wide 2
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
N Dataset for Academic Research - Infusion pump flow IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T Research Medical Device EU - Requirements and Regulations EU Medical Device Regulations 13
Y Change Management in a very complex Research Organization Misc. Quality Assurance and Business Systems Related Topics 3
L EU MDR CRO (Contract Research Organization) requirements for Clinical Investigations EU Medical Device Regulations 1
T Control of R&D (Research and Development) Parts and Equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
I AS9100D - Interview Request - I'm doing research Misc. Quality Assurance and Business Systems Related Topics 1
I Design & Development, Research and Innovation in the Medical Device framework ISO 13485:2016 - Medical Device Quality Management Systems 3
R University Research Project - Management Review Management Review Meetings and related Processes 17
F Scientific and Research Papers for Foreign Approved Devices Other US Medical Device Regulations 1
S Does a Research facility require DEA registration ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Early Research & Development - ISO 13485:2003 requirements Clarification ISO 13485:2016 - Medical Device Quality Management Systems 34
Q IEC 60601 for Non-Medical Research Purpose Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
C Selling of Research products in Europe EU Medical Device Regulations 9
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
E Research or other consents missing from the Donor Medical Chart Document Control Systems, Procedures, Forms and Templates 5
I Is ARIMA (Time Series Analysis) Model appropriate for this Dental Research? Using Minitab Software 4
J Research Use Only for an MD/IVD Kit EU Medical Device Regulations 3
AnaMariaVR2 FDA's Research Strategic Plan (RSP) US Food and Drug Administration (FDA) 0

Similar threads

Top Bottom