FDA Warning Letter on Medical Device Reporting Interpretation

sreenu927

Quite Involved in Discussions
#1
Hi All,

I felt it is interesting to know the FDA's interpretation on Medical Device Reporting and would like to share with you all. This is the recent warning letter from FDA.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm358013.htm

MDR Violations

Our inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act 21 U.S.C. ? 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 U.S.C. ? 360i, and 21 CFR Part 803 ? Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:

Failure of your firm to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. After reviewing your firm?s procedure titled, ?Customer Feedback & Adverse Event Reporting P14.1 Rev. G effective 5/18/11?. The following issues were noted:

(1) QA 4.0 Rev. F does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:

a. The procedure does not include definitions for the terms "remedial action? found in 21 CFR 803.3 and "reasonably known" and "reasonably suggests" found respectively in 21 CFR 803.50(b) and 803.20(c)(1). The exclusion of these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).

(2) QA 4.0 Rev. F does not establish internal systems that provide for a standardized review process or procedure for determining when an event meets the criteria for reporting under this part. Specifically, the following was not addressed:

a. The procedure, as written does not specify who makes the decision for reporting events to FDA.

(3) QA 4.0 Rev. F does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:

a. Instructions for how to obtain and complete the FDA 3500A form.

b. The circumstances under which your firm must submit initial, supplemental or follow-up report and the requirements for such reports.

(4) QA 4.0 Rev. F does not describe how your firm will address documentation and record-keeping requirements, including:

a. Documentation of adverse event related information maintained as MDR event files.

b. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.

In addition, QA 4.0 Rev. F, ?Medical Device Reporting and Vigilance Reporting,? includes references to baseline reporting and annual certification, which are no longer required. We recommend that all references to Baseline Reports and Annual Certification be removed from your firm?s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008; and Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting, Annual Certification, Final Rule, respectively).


Any comments/ views?

Regards,
Sreenu
 
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sagai

Quite Involved in Discussions
#2
I have also had a read of it before and the trouble I have encountered as regard is that I have still not got my lollipop back to be offered again. :tg:
 

Ronen E

Problem Solver
Moderator
#3
My comment is that a Warning Letter referring to MDR usually follows a 483, so getting cited for such minor, technical issues as not having a pointer to the right form or not having a certain term defined is really unnecessary. I never understood why / how companies get there in the first place, when all they need to do is just fix their SOPs accordingly and be done with it.

Or maybe it's a lollipop? ;)
 

Ronen E

Problem Solver
Moderator
#7
Is their an approved definition of REASONABLY SUGGESTS?
21 CFR 803.20:
(...)

(c) What kind of information reasonably suggests that a reportable event has occurred?

(1) Any information, including professional, scientific, or medical facts, observations, or opinions, may reasonably suggest that a device has caused or may have caused or contributed to an MDR reportable event. An MDR reportable event is a death, a serious injury, or, if you are a manufacturer or importer, a malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

(2) If you are a user facility, importer, or manufacturer, you do not have to report an adverse event if you have information that would lead a person who is qualified to make a medical judgment reasonably to conclude that a device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. Persons qualified to make a medical judgment include physicians, nurses, risk managers, and biomedical engineers. You must keep in your MDR event files (described in 803.18) the information that the qualified person used to determine whether or not a device-related event was reportable.
 
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