MDR (Medical Device Reporting) under 21 CFR Part 803

L

Lerotronic

#1
#1
Hi All,

Since topic on MDR reporting to FDA is lacking let's get this discussion started for all of you reporters out there.

I have a questions first actually: If the event was initialy reported to FDA via an MDR but was later deemed that the event is not an MDR reportable event, how does one cancel the previos report?

Thank you all!
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
shimonv

shimonv

Trusted Information Resource
#2
#2
I am not aware of an option to cancel MDR. What you can do is file a follow-up report with additional information and conclusion.

-Shimon
 
L

Lerotronic

#3
#3
shimonv said:
I am not aware of an option to cancel MDR. What you can do is file a follow-up report with additional information and conclusion.



-Shimon
Click to expand...


That is my current logic as well. However I am not sure how does FDA use the data on reporting (and what paremeters are being tracked). Does anyone know if there is a difference between submitting a follow-up explaining that this is a non reportable event and in some way canceling the report?

Any additional data on how does FDA use reported data would also be highly appreciated!

Thanks,
Lero


Sent from my iPhone using Tapatalk
 
shimonv

shimonv

Trusted Information Resource
#4
#4
Lets see who else joins the discussion...
I'll just add that I wouldn't be concern by just one MDR report. There are companies that submits hundreds of MDR reports annually; just look at the MDR public database.

I can only guess that what FDA is looking for is risk-based trends per medical specialty, per company. Your one 'glitch' only show abundance of caution. :)


Cheers,
Shimon
 
Q

QA-Man

#5
#5
shimonv said:
Lets see who else joins the discussion...
I'll just add that I wouldn't be concern by just one MDR report. There are companies that submits hundreds of MDR reports annually; just look at the MDR public database.

I can only guess that what FDA is looking for is risk-based trends per medical specialty, per company. Your one 'glitch' only show abundance of caution. :)


Cheers,
Shimon
Click to expand...
The only time I have experienced problems with MDR's is when they weren't filed.

The only time I had a surprise inspection was when a customer sent two MedWatch forms to the FDA but we did not. Fortunately the FDA agreed with our justification for not doing so but now I would probably just sent them to avoid being on the FDA's radar.
 
L

Lerotronic

#6
#6
Thanks for the reply everyone! Is there any document explaining how is FDA using information provided under 803 and what kind of significance is given to what kind of trends?

More then less is also my logic when reporting, but structure and consisteny is also my high concern in order to drive quality througout the team - hence the questioning on the topic.


Sent from my iPhone using Tapatalk
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 8
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
M MDR - Packaging - Secondary Medical Device Boxes EU Medical Device Regulations 2
C Article 16 MDR - Medicine packaged together with Medical Device EU Medical Device Regulations 0
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 12
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
R Breast Pump under MDR classified as medical device? EU Medical Device Regulations 9
E Under MDR is a medical workstation a medical device or an accessory? EU Medical Device Regulations 5
E Can we still use MEDDEV 2.4/1 rev. 9 when classifying a medical device product under MDR? EU Medical Device Regulations 4
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12
E How is my medical device sofware classified under MDR? EU Medical Device Regulations 2
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 7
M Informational Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019 Medical Device and FDA Regulations and Standards News 2
M New medical device on the market before MDR EU Medical Device Regulations 12
M Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR) Medical Device and FDA Regulations and Standards News 0
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
S Medical device CER (clinical evaluation report) according to MDR EU Medical Device Regulations 24
moounir Medical Device Nomenclature - Free of Charge? (European Union MDR MDR 2017/745) EU Medical Device Regulations 7
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
S Clinical evaluation for a class IIa medical device - EU MDR Requirements EU Medical Device Regulations 3
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10
C "Fast action" claim and MDR (Medical Device Regulations) EU Medical Device Regulations 8
H EU Medical Device Regulations (MDR) Checklist EU Medical Device Regulations 1
C Where to buy the latest MHLW, Canada MDR, Brazil medical device regulations Other Medical Device Regulations World-Wide 2
S MDR (Medical Device Regulations 2017/745) training recommendation for Auditors EU Medical Device Regulations 1
C Substance based Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 10
N New MDR EU Medical Device/IVD Regulations - Definition of Importer EU Medical Device Regulations 1
B Is there a MDR (Medical Device Reporting) equivalent in China ? China Medical Device Regulations 1
E Amendment to Medical Device Directive (MDR) - December 2013 EU Medical Device Regulations 0
S MDR (Medical Device Reporting) Justification - Canned Statements Other US Medical Device Regulations 2
R First MDR (Medical Device Report) - Does the FDA give feedback? US Food and Drug Administration (FDA) 4
L Interpretation of MDR Reportable Event - FDA guidance on Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
R MDR (Medical Device Report) Checklist 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Medical Device Vigilance - MDR or MDD? EU Medical Device Regulations 9
Q When to File an MDR (Medical Device Reporting) For Incidents in Foreign Countries 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
Watchcat Impact of MDR on Availability of Medical Devices in EU EU Medical Device Regulations 5
M MDR Medical devices Gap analysis ISO 13485:2016 - Medical Device Quality Management Systems 2
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
M Informational MHRA guidance updated to reflect the mDR – Clinical investigations of medical devices – Biological safety assessment Medical Device and FDA Regulations and Standards News 1
D Applicable MDR Annex's for Class IIa Medical Devices EU Medical Device Regulations 0
xcanals_tecno-med.es Qualification of sterilization indicators as medical devices with the EU MDR 2017/745 EU Medical Device Regulations 7

Similar threads

Top Bottom