Medical Device Reporting vs Recall/Correction: What action to take?

L

Laurewen

#1
I have read the regulations and guidances, and I feel like I understand the processes for both individually, I just don't understand how they connect.

I work for a small medical device software company and we were recently informed of a reportable malfunction. The malfunction requires correction, however it is not considered "remedial action to prevent an unreasonable risk of substantial harm to the public health" so it does not require the 5 day remedial action report. I understand the MDR Reporting procedure, but I am unsure if I need to initiate any separate action for the correction.

The regultions on corrections or removals state "no report of correction or removal is required under this part, if a report of the correction or removal is required and has been submitted under parts 803 or 1004 of this chapter." Does this apply to any MDR or only to the 5 day remedial action reports?

This just confuses me because at least in our circumstances I can't imagine having a reportable malfunction that wouldn't require a correction, or a recall that wouldn't require an MDR. I'm not sure how to interpret the regulations/guidance on corrections or removals if a report is not required.

I am assuming that I simply submit the malfunction report and work with the FDA through that channel for any correction we make unless they request otherwise. Can anyone confirm this or let me know if I need to take separate action to communicate with the FDA?
 
Elsmar Forum Sponsor
B

biotechreg

#3
if no remedial action to prevent substantial public health risk, and no death possible, and no serious injury possible, then sounds like no report under 21 CFR 803 (MDR), I might also document the reasoning behind why it's not a public health risk etc. by completing a HHE - Health Hazard Evaluation. FDA actually has a form to plagiarise but it's in the OIVD area. You can still use it.
but it sounds like you need to review 21 CFR 7.46 (worst case) or 21 CFR 806. If you are correcting the s/w to remedy a minor violation of the Act - ex. the device failed to meet specs. In 806 it explains when correction is reportable (NOT under 803) and when it is not (Best case). If you are not reporting it, make sure you have complete rationale/justification documented - you're still required to show to inspector. Good luck!
 
Last edited by a moderator:
L

Laurewen

#5
Thank you for your help, but I'm still confused on two points:

1) We will be submitting a 30 day report under 21 CFR 803 (not a 5 day). Does the following exemption under 21 CFR 806 apply to both types of report, just the 5 day report, or a request from the FDA to submit a report after reporting under 21 CFR 803?

"no report of correction or removal is required under this part, if a report of the correction or removal is required and has been submitted under parts 803 or 1004 of this chapter."

2) If the report is not required under 21 CFR 806, but we are still making a correction, which parts of the FDA's "Guidance for Industry: Product Recalls, Including Removals and Corrections" should we follow?

-----If you need more background-----
We will be reporting the malfunction under 21 CFR 803. It was borderline on whether we needed to because the decision commitee unanimously agrees that if it recurs it isn't "likely" to result in serious injury (there are already some risk mitigation measures in place and it is reasonably detectable), but it definitely could, and no one on the commitee was willing to classify the chance as "remote," so to be safe we will be reporting.

However, the comittee decided that we don't need to submit a 5 day remedial action report because the remedial action needed to correct the issue isn't necessary to "prevent an unreasonable risk of substantial harm to the public health" as required under 21 CFR 803 (the chance that the malfunction will recur is very remote, if it does it is more likely to not result in serious injury (see above), and the risk the malfunction creates is already inherent to the field)

However, we will still be correcting the software to reduce risk which is required to be reported under 21 CFR 806 (unless we are exempt)
 
B

biotechreg

#6
Thanks for the clarification. From the earlier/first post, it didn't sound like serious injury was possible if the software fault was to reoccur. Now, it does seem like you need:
- a 30 day report from the awareness date under 803.
- I suggest you fill out a HHE (Health hazard evaluation) to quantify the specific severity (the exact harm from uncorrected s/w flaw) and the estimated frequency and, if applicable, the population impacted (ex. seniors, men in their 40's, nurses, etc.) i would have a medical expert (not a Raqa person) sign it.
- my gut reaction is - if you are filing a 30 day report, it sounds like a reportable correction under 806 is NOT required - as long as the CORRECTION is clear in the 30 day report. just so you know what you're getting into, when you fill out the MDR report and submit, sometimes FDA 'redecides' it is a Class III (minor) recall based on the correction details.
- Also be prepared for review of the DHF during next inspection - showing how the reqts specs, RISK ANALYSIS, detailed design, change and regression testing, and s/w validation were updated. Again, best of luck.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
M Medical Device AE Reporting SOP Medical Device and FDA Regulations and Standards News 0
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 4
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device incident reporting (MDIR) guide Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Statement on agency’s efforts to increase transparency in medical device reporting Medical Device and FDA Regulations and Standards News 0
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 3
M Informational TGA – Medical device annual reporting – Sponsor obligations Medical Device and FDA Regulations and Standards News 0
shimonv Reporting Medical Device Changes with Annex V/VII EU Medical Device Regulations 1
L MDR (Medical Device Reporting) under 21 CFR Part 803 Other US Medical Device Regulations 5
Q Medical Device Reporting In US/ EU/ Canada Customer Complaints 6
N Notification of Changes to a Class I Medical Device - Reporting Requirements EU Medical Device Regulations 4
S Medical Device Reporting SOP (Standard operating procedure) example Other Medical Device and Orthopedic Related Topics 1
A What are the obligatory medical device reporting timelines for AIMD devices ? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Is there a MDR (Medical Device Reporting) equivalent in China ? China Medical Device Regulations 1
A 21 CFR Part 803 (Medical Device Reporting) and Public Health US Food and Drug Administration (FDA) 2
Q Reporting Significant Medical Device Changes to Argentina's ANMAT Other Medical Device Regulations World-Wide 3
S Help with EU Medical Device Vigilance Reporting Requirements EU Medical Device Regulations 0
M Weblinks in Medical Device Reporting Procedures ISO 13485:2016 - Medical Device Quality Management Systems 9
S FDA Warning Letter on Medical Device Reporting Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
R Role of Contract Manufacturer - MDRs (Medical Device Reporting) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
S FDA terms - Adverse Events, Medical Device Reporting, MAUDE and Customer Complaints US Food and Drug Administration (FDA) 1
N Exclusion of Medical Device Reporting of Components for Medical Systems ISO 13485:2016 - Medical Device Quality Management Systems 4
T Reporting changes to a Class II Medical Device in Canada Canada Medical Device Regulations 3
G FDA MAUDE Medical Device Reporting Database Analytics US Food and Drug Administration (FDA) 6
D Malfunctions, 2 year History, and Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Flowchart to explain the Medical Device Vigilance Reporting Process wanted EU Medical Device Regulations 6
T EU Medical Device Vigilance Reporting Requirements EU Medical Device Regulations 3
S MDR (Medical Device Reporting) Justification - Canned Statements Other US Medical Device Regulations 2
T Medical Device Reporting Procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
E Taiwan Medical Device Adverse Event Reporting Other Medical Device Regulations World-Wide 6
C Medical Device Reporting Procedures compliant with FDA and CE Marking Requirements EU Medical Device Regulations 7
T US FDA Medical Device Reporting SOP help 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L Interpretation of MDR Reportable Event - FDA guidance on Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
B Medical Device Vigilance Reporting Multi Markets Other ISO and International Standards and European Regulations 2
M Who regulates Medical Device? Global Medical Device Reporting Process Other Medical Device and Orthopedic Related Topics 6
bio_subbu OIG Reports on Medical Device Adverse Event Reporting system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C Medical Device Reporting procedure - Correction and Removal (21 CFR 806) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Draft Guidance: eMDR - Electronic Medical Device Reporting (Updated) US Food and Drug Administration (FDA) 3
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
O Medical Device Reporting - MDRs for incidences outside the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Canadian Medical Device Reg -- Mandatory Reporting? Various Other Specifications, Standards, and related Requirements 1
D Swiss Documentation Requirements for Class 1 Medical Device Other Medical Device Related Standards 0
A Medical Device including a smartphone - CE mark ? CE Marking (Conformité Européene) / CB Scheme 4
C VOCs as extractable in substance based medical device EU Medical Device Regulations 0
S Mexico medical device registration - for demo Other Medical Device Regulations World-Wide 1
S EU Medical Device Regulations EU Medical Device Regulations 6
K Sample size calculation for the medical device with multiple indications. e.g. suture US Food and Drug Administration (FDA) 3

Similar threads

Top Bottom