The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical device reporting. The present article focuses on the reporting requirements of medical device manufacturers. The document is intended to provide medical device manufacturers with additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered.
Table of Contents
It is important to mention that the provisions of the guidance are non-binding due to its legal nature. Interested parties may apply an alternative approach, provided such an approach complies with the applicable regulatory requirements.
Voluntary Report: Investigating Responsibilities
According to the document, a medical device manufacturer shall first rigorously evaluate all the information available in order to determine whether the event in question is subject to reporting under the applicable regulatory framework. The scope of such evaluation should cover all the information actually or reasonably available to the manufacturer. The authority additionally mentions that the manufacturer is allowed to contact the customer or healthcare facility involved in order to obtain additional details, apart from those provided in the initial incident report. The final decision regarding the determination of an incident as a reportable or non-reportable event should be based on the evaluation of the points highlighted above.
Serious Injury
One of the most important concepts used in the context of medical device reporting is the concept of a “serious injury,” which should also be used to determine whether the incident is subject to reporting under the current regulatory requirements.
According to regulation 21 CFR 803.3, a “serious injury” is one that:
- Is life threatening;
- Results in permanent impairment of a body function or permanent damage to a body structure; or
- Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
For the purpose of the guidance, “permanent” means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.
In this regard, the authority explicitly emphasizes two important points to be taken into consideration:
- Damage that is cosmetic it is nature should be deemed trivial;
- Any and all life-threatening injuries are considered to be serious injuries irrespectively of whether the threat is temporary.
Medical Device Malfunction Subject to Reporting
The document further describes in detail the concept of malfunction of a medical device that triggers reporting obligations of its manufacturer. According to regulation 21 CFR 803.3, a “malfunction” stands for the failure of a device to meet its performance specifications or otherwise perform as intended. It is important to mention that for the purpose of this provision, the actual scope of “performance specifications” also covers any and all claims and statements regarding the performance of the device made by its manufacturer.
The authority additionally emphasizes that if a malfunction occurred at least one time, it should be presumed that it will also occur later.
In accordance with the applicable requirements, the reporting obligations with regard to malfunctions should be triggered if:
- There is a high probability of a serious injury caused by the malfunction identified (occurred at least once);
- Once occurred, the malfunction would result in a serious injury;
- The malfunction impacts normal operations of a medical device;
- The malfunction involves:
- A long-term implant or
- A device that is considered to be life-supporting or life-sustaining and thus is essential to maintain human life;
- In order to mitigate risks associated with the malfunction and prevent further harm it could cause to patients or customers, the medical device manufacturer would have to take additional measures.
However, the FDA also mentions that the points listed above should be considered in connection with each other. For instance, according to the example provided in the document, the malfunction of a long-term implant is reportable only when the malfunction would be likely to cause or contribute to a serious injury if it were to recur, otherwise the malfunction would not be subject to reporting. The severity of the consequences of the malfunction should be the main criteria medical device manufacturers use in order to determine whether the particular malfunction is subject to reporting. This applies even if such a malfunction could be easily corrected in the course of the ordinary maintenance of the medical device in question.
When describing medical devices, the FDA also refers to the concept of similarity. According to the document, one device is deemed to be “similar” to another one if both devices have the same:
- Basic design and performance characteristics related to device safety and effectiveness; and
- Intended use and functions; and
- Device classification and product code.
Thus, if the only difference between two medical devices lies in minor characteristics that are not significant in their nature and do not impact the safety or performance of such devices, they could be deemed similar.
Apart from this, when determining whether the devices are similar, one should also consider the following aspects:
- Brand name;
- Common name;
- Whether the devices in question have been placed on the market under the same regulatory framework: 510(k) premarket notification or premarket approval application (PMA).
Determining the Likelihood of an Injury
As mentioned, the analysis of risks associated with a medical device and malfunctions that could take place constitutes one of the most important factors to be considered when determining whether an incident in question is subject to reporting. Under the general rule, a malfunction should be reported if it is likely to cause or contribute to serious injury. For instance, if such a malfunction has already caused or contributed to serious injury, it should be considered one which is likely to cause or contribute to serious injury and thus is subject to reporting. Once the manufacturer has become aware of any such incidents associated with a device for which it is responsible, there is an obligation of the manufacturer to conduct further investigation. Moreover, such an investigation should be duly documented, while such records should be kept and later provided to the regulating authority upon request.
When the manufacturer decides to cease reporting, it should also notify the regulating authority. In such a case, the Agency is entitled to request medical device manufacturer to provide additional information, apart from the general justification to be provided by default. A notification on ceasing reporting should be an official document issued on the letterhead of the company. It should also contain references (report number) to the last report associated with the malfunction in question.
In summary, the present FDA guidance describes in detail the reporting obligations of medical device manufacturers and how they could be triggered. The document also provides additional clarifications regarding the most important concepts, such as “serious injury” or “malfunction.”
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