Recognized Symbols for Device Labeling? 510k to the FDA

M

mlabardi

#1
We recently submitted a 510k to the FDA for a ob/gyn cell collector. The product is single use and will only be utilized by doctors in a professional setting (will not be available to the public).

We followed the FDA "Guiance for Insustry and FDA Staff-Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use". We included the symbol on the label with a "2" with a circle and slash through it to distringuish this item as a single use item, as well as an hour glass for expiration date, and a symbols for see instructions for use.

We received a letter from the FDA with some concerns about the labeling which state "device labels include non-recognized symbols for single use only, see instructions for use, and expiration date. Please replace these symbols with text".

The request may seem simple to replace with text but our labels have mutiple languages and are relatively small and we want to keep everything clear. We do plan on complying with the FDA request.

We reviewed other devices that our similar to ours that used the same symbols. We thought that FDA document would be applicable to our device but now we are wondering why the FDA would say the symbols are non-recognized. Any insight would be helpful.:confused:
 
Last edited by a moderator:
Elsmar Forum Sponsor
R

Roland Cooke

#3
Is the cell collector invasive? If so, then the guidance mlabardi has referenced is not appropriate, as it applies to IVDs only.

The whole labelling thing has always been a sore issue, so I'm interested in what the current FDA position is, and what the future might be.


European love symbols, because of the many languages within the EU, and the space savings that entails. Over time, users have learnt what the symbols mean too (no small importance!).

But these factors are less critical in the US, where English is the main language, and users have little experience with many of these wierd symbols.

Of course there IS a problem when it comes to IVDs, since many of these products are tiny. So it is actually interesting (and positive) that the FDA has bought into the use of symbols for those devices.

Possibly FDA is considering letting the IVD symbols become established, then allowing IVD dual-labelling (symbols and text) for a few years, and finally allowing symbols only where appropriate.

If anyone has some up-to-date information, that would be appreciated.
 
Q

QualiMedd

#5
We have successfully submitted Medical Device 510k's for ages using EN980 symbols.

Just this week I had a 510k rejected because the Food and Drug Administration say they want text as well as the symbols.

Is this a new requirement or are the Food and Drug Administration being picky?
 
M

MIREGMGR

#6
Approximately a year ago, we were told by Terrell Cunningham, an FDA 510(k) examiner in the Office for Device Examination (ODE), in regard to one of our 510(k) submissions that the referenced FDA guidance document was the current FDA standard for symbol acceptability.

In our original submission, we had used a symbol from either EN980 or EN ISO 15223-1 that one of our European customers had requested be on their worldwide-distribution label, but that was not included in the IVD-document set. We were directed either to provide English subtext or to replace that and any other non-IVD-set symbol.

I think we know from other evidence that there's something of a turf war within FDA between the USA-only traditionalists and the global-harmonization fans, among whom are Tim Ulatowski, Margie Shulman and others from CDRH's Office of Compliance. I think that dispute or turf war is why, for instance, the previously Tim-Ulatowski-publically-discussed program under which an ISO 13485 audit report would be accepted by the FDA as a substitute for an FDA-conducted first-tier QSIT-1 field inspection program, supposedly "to be announced soon", hasn't been heard from since.

My understanding is that the FDA's global-harmonization faction envisions that eventually the FDA's first-tier QSIT-1 inspection effort might be entirely replaced by the FDA medical-devices world being required to be certificated to ISO 13485 (and much more frequently audited, at their own expense, than the FDA can manage at no cost to the inspected firms given their field resource limits), with the FDA providing the legal backup to write 483s based on ISO audit reports and subsequently providing only the inspections-for-cause.

I've heard that perhaps some of the higher-ups in the Office for Regulatory Affairs (ORA, which manages the large field-inspection hierarchy, almost half of all FDA personnel) and the upper FDA heirarchy below the politically-appointed level are on the other side of that dispute.

My guess is that this symbol issue, coming to us through the ODE, is a facet of that internal global-harmonization-is good/global-harmonization-is-bad argument, which is related to the future of the FDA's field-inspection role.
 
A

alex FEI

#7
Hello,

As i know, the symbols you mentioned above are originated from EN harmonized standard, EN 980. Maybe FDA does not accept these symbols as general ones which could be recognized by American public.

And as your products are intended to be distributed in USA, why you have to include multi-language information in the label.

:D:D

Alex
 
Thread starter Similar threads Forum Replies Date
L Device Labeling - Stand Alone Symbols of ISO15223 no longer FDA recognized Other US Medical Device Regulations 2
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Medical Device and FDA Regulations and Standards News 0
M Informational Links to recognized / harmonised / consensus Standards for each market Other Medical Device Related Standards 5
M Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices Canada Medical Device Regulations 3
D Help identify a Nationally Recognized Testing Laboratory (NRTL) (UL) certified lab General Measurement Device and Calibration Topics 3
I Procedures from recognized standards or specifications ISO 17025 related Discussions 3
A List of FDA recognized standards for medical devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Y Consultation: EN 980 still recognized by EU regulation? EU Medical Device Regulations 4
M FDA Acceptance of ISO 13485 Reports from a Recognized International Program Other US Medical Device Regulations 4
H Are ASQ certifications recognized in Canada? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
B AS 9100C sec 8.2.4 - " Recognized Statistical Principles" meaning AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
C Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices? Other US Medical Device Regulations 1
Q FDA - Modifications to the List of Recognized Standards: List Number 026 US Food and Drug Administration (FDA) 1
T Australia TGA Approval recognized by New Zealand? Other Medical Device Regulations World-Wide 7
thisby_ EMC/FCC part 15 test (NRTL - Nationally Recognized Testing Laboratories) required? US Food and Drug Administration (FDA) 1
automoto Requirements of certification bodies recognized by IATF for ISO/TS 16949:2002 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 12
K List of Recognized product certification by country for Medical Device Various Other Specifications, Standards, and related Requirements 4
J Use of FDA recognized standards: IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
B Weld Specifications - EU vs. AWS - Are AWS procedures recognized by the EU? Manufacturing and Related Processes 2
E ISO 9001 QMS for Maritime Survey Co. aka Recognized Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Master Black Belt Certification - Looking for recognized MBB certification course Training - Internal, External, Online and Distance Learning 3
P Seeking Nationally and Internationally recognized Calibration Procedures General Measurement Device and Calibration Topics 7
Antonio Vieira IQNET ? International Certification Network - Really a recognized Organization? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Disagreement concerning 4.10.6.5 - National Recognized vs 'Home Grown' Procedures General Measurement Device and Calibration Topics 4
D Hazard symbols and labeling ISO 13485:2016 - Medical Device Quality Management Systems 1
S ISO 15223-1:2020 Symbols Other Medical Device Related Standards 1
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
S How to decide which medical device symbols go on label and labeling? US Food and Drug Administration (FDA) 5
S REF and CE mark symbols on multi-component device EU Medical Device Regulations 3
T Colour of symbols on Medical Device labelling and packaging Other Medical Device Related Standards 1
M Informational Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR Medical Device and FDA Regulations and Standards News 5
S Symbols - Device label versus Packaging label ISO 13485:2016 - Medical Device Quality Management Systems 1
ernieto CE marked IVD - Does the "IVD" symbols needs to be in the IFUs? CE Marking (Conformité Européene) / CB Scheme 2
J CE Marking Requirements and IEC 60617 - Electrical Schematics Symbols CE Marking (Conformité Européene) / CB Scheme 1
ernieto Where can I buy ISO-15223-1 CD with graphic symbols? Other Medical Device Related Standards 13
E ISO 15223-1 (Medical Device Label Symbols) - Revisions, EU commission? Other ISO and International Standards and European Regulations 1
K Which Symbols are used in Process flow diagrams? Manufacturing and Related Processes 2
K EN ISO 15223-1:2012 Clarification or Examples on when to use Safety Symbols Other Medical Device Related Standards 3
K Color to be used for the Packing box Symbols Other Medical Device Related Standards 2
M Final rule on use of symbols on labeling - Symbols without text under some conditions Other US Medical Device Regulations 12
S Family / Generic type of FMEA & Control Plan and Symbols FMEA and Control Plans 3
S Labeling Symbols for EU - E.g. EN980 - Dimension, color, font, etc. Other ISO and International Standards and European Regulations 6
I JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels Japan Medical Device Regulations 2
E Unfamiliar Blueprint Symbol - Hex Symbols Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
M Words as Symbols in Software EU Medical Device Regulations 7
J Medical Device Labeling and Symbols - US and EU Requirements CE Marking (Conformité Européene) / CB Scheme 6
C Device Labeling - Safety Symbols for Washbasin with a Submerged Pump EU Medical Device Regulations 5
Jim Wynne GD&T Symbols: Lost in Translation Coffee Break and Water Cooler Discussions 5

Similar threads

Top Bottom