The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published detailed guidelines describing recalls, corrections, and removals in the context of medical devices.
The document is intended to provide medical device manufacturers and other parties involved in operations with medical devices with additional clarifications regarding current regulatory requirements and recommendations to be followed to ensure compliance thereto. By virtue of the present guidelines, the FDA explains how the respective provisions of existing legislation should be interpreted.
Mandatory Device Recalls
Under the general rule, medical device recalls are usually initiated by the medical device manufacturer as the party responsible for a medical device placed on the market. Usually, the manufacturer identifies the issue, develops a recall plan, and conducts the recall engaging other parties (e.g., distributors) if necessary. Should the manufacturer responsible for a non-compliant medical device fail to initiate the appropriate actions, the regulating authority is entitled to initiate a mandatory recall in order to ensure the safety of patients. In particular, regulation 21 CFR 810 allows the authority to issue a recall order and describes further steps to be taken by the Agency in accordance with section 518(e) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Should the authority become aware of serious safety-related issues associated with a medical device placed on the US market, where such issues could result in severe health deterioration or expose patients to other risks, the authority is allowed to take additional regulatory measures to address the hazards according.
In particular, the Agency is entitled to issue a cease distribution and notification order requiring the person named in the order to immediately:
- Cease distribution of the device;
- Notify health professionals and device user facilities of the order; and
- Instruct these professionals and device user facilities to cease use of the device.
Once such an order is received, the responsible party may argue the request by providing the appropriate justification in writing. The authority is also allowed to initiate a recall, should it be reasonably necessary to ensure the safety of the patients and other persons using the device in question.
Corrections and Removals
According to the provisions of regulation 21 CFR 806, medical device manufacturers, as well as importers engaged in supplying medical devices to the US, are obliged to duly notify the regulating authority about any and all corrections or removals initiated with regard to medical devices already placed on the market if such actions are initiated in order to mitigate risks to which the patients are exposed or eliminate non-compliance with the applicable regulatory requirements the device should meet due to its regulatory status. The appropriate report should be submitted to the FDA without undue delay, even if the incident is likely due to user error. In this regard, the Agency further refers to the FDA guidance on Medical Device Reporting.
Moreover, both medical device manufacturers and importers are obliged to follow corresponding record-keeping requirements with regard to corrections and removals that do not meet the reporting criteria. At the same time, the party responsible for a medical device is allowed to submit a voluntary report if a mandatory report in that particular situation is not required. The guidance further describes this rule in the following way:
- In the case of Class I and Class II recalls, the submission of a report on corrections and removals is mandatory; but
- In the case of Class III recall, it would be sufficient for a responsible party to keep the records related to the recall as prescribed by the applicable regulations.
The authority additionally outlines the scope of actions that are explicitly exempted from reporting requirements. For instance, the scope of exemption covers any actions intended to improve the overall performance of a medical device, provided that it is not in any way related to risks associated with the medical device or its non-compliance to the applicable regulatory requirements. Examples of exempted actions include the following:
- Market withdrawals;
- Routine servicing; and
- Stock recoveries.
Reporting Obligations in Detail
The document further provides clarifications regarding the parties responsible for reporting, as well as the applicable timeframes. Should a medical device manufacturer or importer initiate a recall of a medical device already placed on the market, and the underlying reason for such a recall be based on the risks associated with such device, the entity initiating the recall shall duly submit the appropriate report to the FDA. Under the general rule, such a report should be submitted no later than 10 days from the moment the recall has been initiated. Should a correction or removal not be connected with a “risk to health,” it would be sufficient for a party initiating it to keep the records to be able to provide them once requested.
The report to be submitted to the FDA with regard to the actions taken by the medical device manufacturer or importer in order to mitigate the risks associated with a medical device or prevent harm caused to the patients should contain the following information:
- Details for making references, including the registration number of the report and the indication of a date, as well as a sequence number. Additionally, it is important to indicate the letter “C” or “R” for correction or removal, respectively.
- Information about the responsible party initiating the action, including its name, address, phone number and contact person.
- Names used to market the device in question and indication of its intended use.
- Indication of the regulatory status of the medical device, e.g., the reference to the particular framework under which it was initially placed on the market.
- Model/catalog number, lot/serial number.
- Contact details of the medical device manufacturer, if the party initiating the action is not a manufacturer.
- Details about events and actions that have already been taken, as well as the ones intended to be taken.
- Details about incidents associated with the device in question, including the references to the Medical Device Reports.
- The number of devices subject to the Correction or Removal.
- Date of manufacture or distribution; expiration date or expected life.
- Details of the parties the devices have been supplied to.
- A copy of all communications regarding the correction or removal.
- A statement as to why any required information is not available and a date when it will be submitted.
With regard to the particular way the report should be submitted, the Agency mentions that there are two options available:
- FDA Electronic Submission Software (eSubmitter), or
In summary, the present FDA guidance describes how the party responsible for a medical device should notify the regulating authority in case of corrections and removals initiated due to safety-related matters. The document also provides additional clarifications regarding the cases when the FDA is entitled to require the party responsible for a medical device to take additional actions in order to ensure the safety of patients and other persons using the device for which the safety concerns exist.
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