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 intended to provide medical device manufacturers with additional clarifications and recommendations on the matter. The present article describes the applicable requirements in the sphere of medical device reporting related to developing and implementing written procedures, record-keeping, and public disclosure.

It is important to mention that the provisions of the guidance are non-binding due to the legal nature of the document itself. Moreover, an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been approved by the authority in advance.

Developing Documented Procedures

First, the document outlines the scope of responsibilities of medical device manufacturers related to the development and implementation of medical device reporting procedures. According to the document, a manufacturer shall establish an efficient system ensuring that any and all incidents associated with medical devices a manufacturer is responsible for that meet the reporting criteria are duly identified and investigated, the investigation procedure itself is fully compliant with the applicable regulatory requirements, and the appropriate reports are provided to the FDA without undue delay. In accordance with the applicable regulations, the procedure to be developed and implemented by a medical device manufacturer should also include requirements for: 

  • Information that was evaluated to determine if an event was reportable;
  • All medical device reports and information submitted to us;
  • Any information that was evaluated for the purpose of preparing the submission of annual reports; and 
  • Systems that ensure access to information that facilitate timely follow-up and inspections by [the FDA]. 

Thus, the documented procedure for medical device reporting should cover any and all requirements set forth under the appropriate legislation. As stated in the guidance, it is preferable to have a medical device reporting procedure as a separate document. However, it could also be a part of another procedure, provided that the part related to medical device reporting is duly separated. In general, such a procedure should describe how the manufacturer would treat adverse events associated with medical devices for which it is responsible. For instance, it should describe the approach to be applied by the manufacturer in order to obtain additional information regarding an event that potentially meets the reporting criteria, including the particular way the reporter should be contacted. 

Record-Keeping Requirements 

The guidance further describes the obligations of medical device manufacturers in the sphere of keeping records related to medical device reports. It is stated that all the materials related to medical device reports should be kept separately in order to ensure ease of access. Each report submitted to the FDA should contain a detailed description of actions taken by the responsible entity in the course of an investigation of the incident. In particular, there should be details on all attempts made by the manufacturer to get additional information about the reportable incident and the responses provided by the reporter. Should the manufacturer fail to obtain additional information, the reasons for this should be properly explained as well. The general idea is that the information to be provided by the manufacturer should clearly demonstrate that all the actions needed to collect information about the event in question have been duly performed. 

According to the applicable regulatory requirements, the materials related to medical device reports should be kept for two years from the date the incident in question occurred, or the whole period of the expected life of the medical device, if the latter is longer. The aforementioned rule should be applied even if, in the course of an investigation, the manufacturer has identified that the incident does not meet the reporting criteria or the manufacturing or supply of the medical device subject to review has been ceased. For the purpose of guidance, the concept of the “expected life of a device” stands for the time that a device is expected to remain functional after it is placed into use. Such a definition is provided in regulation 21 CFR 803.3. 

It is further explained that the information medical device report files should contain shall cover the following aspects:

  • All the information the manufacturer has with regard to the incident associated with the medical devices, including all reports and records, as well as the documents describing the decision-making process. It should also be supplemented with the indication of a particular person who has taken a decision. Upon completion of an investigation, the manufacturer shall also add information regarding the underlying cause of the incident, as well as the actions taken to mitigate the risks.
  • Copies of all medical device report forms received by the manufacturer with regard to the adverse event. The records to be maintained by the manufacturer include documented phone calls and letters received.

The authority additionally emphasizes that the manufacturer shall, upon request of the authority, provide access to FDA’s authorized persons to the documents related to the MDR reports. 

Information Subject to Disclosure 

In order to assist medical device manufacturers in complying with the applicable regulatory requirements in the sphere of information disclosure, the document also describes the approach to be applied when determining whether the information is subject to public disclosure or should not be disclosed. In particular, it is stated that any report submitted to the FDA could be disclosed upon the appropriate request. However, before disclosing the report, the authority will remove certain information, namely: 

  • Information that constitutes trade secret or confidential commercial or financial information under 21 CFR 20.61;
  • Personal, medical, and similar information (including the serial number of implanted devices), which would constitute a clearly unwarranted invasion of personal privacy under 21 CFR 20.63 (this includes the identity of the patient as well); and
  • Names and other identifying information of a third party that voluntarily submits an MDR report. This includes physicians, health care professionals, or other hospital employees. 

Should a disclosure request be submitted by a patient, the information disclosed will include all information related to the report, apart from the information that is confidential in its nature.

In summary, the present FDA guidance provides additional recommendations regarding the written policies to be developed and implemented by medical device manufacturers, clarifies the applicable regulatory requirements in the sphere of record-keeping, and also outlines the scope of information that could be disclosed by the FDA upon request. The provisions of the guidance are intended to assist manufacturing in following the rules set forth under the current legislation on medical device reporting. 


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