Reporting Internally Discovered Defects

What Internally Discovered Defects Must Be Reported as MDRs by the Manufacturer?

By Angela Nunez, AccuReg Inc.

DEFINITION OF MDR

21 CFR 803.3 defines MDR as: Medical device report. It defines MDR reportable event as being one of the following:

An event about which user facilities become aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or

An event about which manufacturers have received or become aware of information that reasonably suggests that one of their market devices:

May have caused or contributed to a death or serious injury; or

Has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

21 CFR 803.50 also states that Device manufacturers are required to report within 30 days whenever the manufacturer receives or otherwise becomes aware of information from any source, that reasonably suggests that a device marketed by the manufacturer may have caused or contributed…. FDA considers the following information to be known to manufacturers:

Any information that can be obtained by contacting a user facility, distributor and/or other initial reporter;

Any information in a manufacturer’s possession; or

Any information that can be obtained by analysis, testing or other evaluation of the device.

The term “become aware” is defined in 21 CFR part 803.3 as meaning that an employee of the entity required to report has acquired information reasonably suggesting a reportable adverse event has occurred…. Comments on these final regulations (Dec 11, 1995) read: “FDA believes that manufacturers have a direct responsibility to inform employees to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports. Accordingly, FDA generally considers that a manufacturer becomes aware of an adverse event whenever any employee becomes aware of an adverse event.”

The comment section mentioned above also indicates that: Manufacturers of devices not being commercially distributed but which are being used under an investigational device exemption, are required to report adverse events under parts 812 & 813 and are not required to submit reports under part 803.

The same section discusses a comment made about 21 CFR part 803.15. This section refers to additional information that the FDA may request to investigate an MDR. It states: “…FDA will not be requesting information in the absence of a device failure or complaint.”

DEFINITION OF COMPLAINT

Section 820.3(b) of the CFR 21 defines complaints as: “…any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.”

A CDRH publication of December 1996 (HHS Publication FDA 97-4179) interprets the definition of a complaint as follows:

“The sources of oral and written communication are numerous. A manufacturer can receive this information via telephone, facsimile, written correspondence, sales representatives, service representatives, scientific articles, and FDA or internal analysis. Information will also be submitted by health care professionals, lay users, consumers, user facilities and distributors on the MedWatch Forms FDA 3500 and FDA 3500A.” (Chapter 15, Complaints.)
Note that this document also states that:
”Although this guidance document does not create or confer any rights for or on any person and does not operate to bind FDA or the public, it does represent the agency’s current thinking on guidance for quality systems.”

Where this document reiterates a requirement imposed by statute or regulation, the force and effect as law of the requirement is not changed in any way by virtue of its inclusion in this document.

The document “Medical Device Reporting for Manufacturers” published in March 1997 by DSMA interprets the definition of complaints as follows: “A complaint is any indication of the failure of a device to meet customer or user expectations for quality or to meet performance specifications. A complaint may be lodged against any finished device released for distribution.”

GENERAL INFORMATION

A warning letter published in December 1, 1998, acting District Inspector Marguerite E. Eagan from the Philadelphia District wrote the following with respect to MDRs: “It is the agency’s position that if a malfunction has never led to a death or a serious injury, and a firm can document this conclusion, it is not MDR reportable. This rule applies unless there is a compelling clinical evaluation to indicate that the event would be likely to cause or contribute to a death or serious injury, even though previous deaths or serious injuries had not occurred.”

The guide to inspections of Medical Device Manufacturers published in December 1997, instructs FDA inspectors to check for MDR reportable events when reviewing complaints. The compliance program requires an MDR inspection every time a GMP inspection is made of the medical device manufacturer.

21 CFR part 803.18 allows the manufacturer to maintain MDR event files as part of complaint files as long as they are clearly identified as MDRs.

The medical device reporting for manufacturers publication from March 1997 regarding MDR event files reads: “MDR files must contain information related to the event, including all documentation of deliberations and decisions processes used to decide whether the event was or was not reportable; and the original or a copy of the initial record complaint/event….”

CONCLUSIONS

If an event occurs with a device in-house, that is a failure or malfunction that can be the cause or be a contributor to death or serious injury, and the device is marketed by the manufacturer, then it is a reportable event (BY DEFINITION OF MDR).

The question of whether or not it should be handled as a complaint is not clear. The discussions on MDR guidelines published by FDA talk of complaints/events when it refers to MDRs. This suggests that not all MDRs are complaints. However, the definition of complaints refers to any communication (including internal analysis) that alleges deficiencies of a device that is released for distribution. This suggests that any failure or malfunction, wherever it is found, is a complaint (including MDR reportable events that occurred in-house).

The guide to FDA inspectors, instructs inspectors to look at complaints and check if there are MDRs linked to them. It does not prompt them to go to MDR files in particular. This suggests than an FDA inspector will not expect to find MDRs not related to complaints. However, the guide “Medical Device Reporting for Manufacturers” makes a clear distinction between MDR files and complaint files. It also indicates that the manufacturer is allowed to maintain MDR event files as part of complaint files.

These statements indicate that if an internally discovered defect is a reportable event, and the product has been marketed already, it should be documented in the MDR files. It should be reported to FDA unless the firm has a sound clinical/scientific rationale to support that the malfunction has never led to death or serious injury.

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