"Indication for Use" Identifying Specific Procedures

ThasYuwa

Inactive Registered Visitor
#1
Greetings everyone,
I have come across 510k summary documents where the following phrase is used in Indication for Use. I include generic description of text before and after the statement to help understand the context:
<few lines describing intended use of the device>
The subject device supports, but is not limited to, the following surgical procedures:
<procedure 1>
<procedure 2>
<procedure 3>

My clarification:
Is there any advantage for using the phrase "but is not limited to" in the indication for use? Does this give the manufacturer of the subject device the ability to claim other procedures in their promo material provided the procedures are closely related to those listed in the indication for use?
I have seen such text in patents where the intent is to claim that other similar methods are already anticipated in the submission. I doubt such broad claims can be claimed in Indication for Use.
Or, am I reading too much into this and I should merely interpret said text as text that simply lists the indicated procedures?

Any and all pointers will be much appreciated.
Cheers
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Some FDA reviewers will balk at an open-ended indication like that, because it might be used to claim conformance at a later time for a procedure that the reviewer otherwise would have rejected.

In my experience, many FDA reviewers would rather that the application describe what is common about the entire class of procedures that are to be included in indications. Then there is an objective basis for managing the applicability of the PMN or PMA.

There always are examples to be found in FDA's work of deviations from norms, though.
 

ThasYuwa

Inactive Registered Visitor
#3
I agree with your observation as well; however, this is a terminology that I observed in a cleared 510k summary. I thought I was missing a lingo that was perhaps commonplace in indication for use.
 
Last edited:
Thread starter Similar threads Forum Replies Date
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
K 510(k) expanding the indication for use for a cleared device Other US Medical Device Regulations 9
S Indication of Inoperable ECG test result IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Colour of indication for ALARM SIGNAL inactivation states IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
E IEC 60601-2-57 item 201.12.4.2 - Indication of parameters relevant to safety IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Indications for Use - Is it possible to have a different indication for use EU Medical Device Regulations 1
I Adverse Event Reported during Non-Approved Indication Use EU Medical Device Regulations 4
R Coexisting Investigational Use and CE-Mark - Adding a new Indication EU Medical Device Regulations 4
V Changing Indication of Use for a Class IIa Medical Device EU Medical Device Regulations 2
V Old 510(k) with no Indication Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Class II Medical Device - Marketing vs. Indication For Use (IFU) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Indication for Use/Intended Use/New Use - Different look but functionally the same 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S CE Label having the indication for the applied part EU Medical Device Regulations 7
C Requirements or Guidance for Pediatric Indication for Use (IVD) EU Medical Device Regulations 4
Mohammed Gouda What is the indication of "adjusted scale correction" to calibration of liq thermom.? General Measurement Device and Calibration Topics 5
T "Indication for Use" used in 510(k) - Indications for Use vs. Intended Use ISO 13485:2016 - Medical Device Quality Management Systems 7
P Verifying improvement results - Indication that controls have worked Statistical Analysis Tools, Techniques and SPC 5
P Temperature indication In Vitro Medical Devices USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Identifying Applied Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
DuncanGibbons Best practice for identifying "items" of parts for DFMEA analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Identifying Technologies for Non Destructive Examination of steel brazed joints Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Identifying internal issues.. at what level? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D Identifying externally provided services referenced by IATF16949 IATF 16949 - Automotive Quality Systems Standard 2
Marc ISO 9001:2015 - Identifying interested parties, or stakeholders ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Identifying AS9100 for a Legacy Product Manufacturing and Related Processes 11
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
S Identifying Objectives & Targets for Quality Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J API Q1 5.6.1.2 (iii) Identifying how the supplied product conforms Oil and Gas Industry Standards and Regulations 1
A Identifying context for every process in an organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
LRE67 Need help identifying this "thing" Coffee Break and Water Cooler Discussions 9
Y Identifying lighting requirements for in house Calibrations General Measurement Device and Calibration Topics 8
A Identifying and Tracking Customer Specific Requirements Customer and Company Specific Requirements 1
P Identifying Medical Device Class and Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Identifying gaps over ISO 13485 to be compliant to MDD 93/42/EEC requirements EU Medical Device Regulations 5
A Please suggest analysis for identifying the warranty Reliability Analysis - Predictions, Testing and Standards 1
P Renault CSR - Identifying the difference between an ASES and ASAS-P Audit IATF 16949 - Automotive Quality Systems Standard 4
Q Identifying Critical Items and Key Characteristics - Product Realization Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Procedure for Maintaining Industry Standards and Identifying Revisions Document Control Systems, Procedures, Forms and Templates 1
S Identifying Processes in a Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Risk Factors Checklist identifying the Risks for meeting the Customer Indent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Identifying version of Standards in Functional Specification of a New Device ISO 13485:2016 - Medical Device Quality Management Systems 6
K Identifying Required Testing to comply with IEC 60601 EU Medical Device Regulations 4
C Document Control and Identifying Distribution ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H Identifying Potential Automotive Suppliers before Developing New Products Supplier Quality Assurance and other Supplier Issues 2
R Identifying procedures that are NOT required by ISO 9001 Quality Manager and Management Related Issues 17
N Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements Document Control Systems, Procedures, Forms and Templates 13
J Help in identifying Legal and other requirements for Indian localisation Miscellaneous Environmental Standards and EMS Related Discussions 4

Similar threads

Top Bottom