The Food and Drugs Administration (FDA), the US authority responsible for medical device regulation, has published a guidance document dedicated to the annual reports for Pre-market Approval Applications (PMA) that have been approved.
Regulatory Background
According to the PMA approval order, those medical devices subject to pre-market approval under the Federal Food, Drug, and Cosmetic (FD&C) Act are also subject to reporting requirements. The present FDA guidance is intended to provide the manufacturers and other parties involved in operations with medical devices. In particular, the document outlines the information the entity responsible for a medical device shall submit to the regulating authority in accordance with the applicable reporting requirements including the level of details to be ensured, the approach applied by the Agency when reviewing the annual reports. The guidance describes the way the annual reports should be prepared in order to ensure the completeness of the information provided and compliance with other applicable FDA reporting requirements.
At the same time, due to its legal nature, the present FDA guidance does not introduce any mandatory requirements the entities responsible for medical devices shall follow and only provides the non-binding recommendations instead.
FDA Reporting Basics
As it is stated by the Agency, post-market surveillance constitutes an important part of a set of regulatory actions taken by the FDA to ensure that any and all medical devices marketed in the US actually meet the applicable safety and performance requirements. In this case, the data to be collected by the means of post-market surveillance activities becomes one of the key sources of information about the device during its whole lifecycle.
Annual reports covered by the scope of the present FDA guidance are intended to provide the regulating authority with a wide range of information about the changes made to the medical device itself, its labeling, or the manufacturing process. In particular, the annual report shall cover all changes that took place during the year. The Agency emphasizes the importance of presenting such information in a way simplifying its review for regulating authority. For instance, the FDA recommends supplementing the information describing the changes made to the device with the detailed justification of such changes describing the actual reasoning behind the reported changes.
PMA Annual Report Requirements
The FDA also describes in detail the requirements the annual report shall meet. According to the applicable regulations, the reports should be submitted once per year starting from the date the initial PMA has been approved. However, in certain cases, the Agency is entitled to require the applicant to provide the reports more frequently, providing that it is necessary due to the safety and performance matters. The present FDA guidance covers only the periodic reports, while the reports that should not be submitted on a regular basis are actually falling outside the scope of the present document.
The general rules regarding the requirements for PMA annual reports are set forth by the regulations 21 CFR 814.82(a)(7) and 814.84(b). In accordance with the aforementioned regulations, the annual report shall contain:
- All changes subject to mandatory reporting,
- Summary and bibliography regarding the unpublished clinical investigations or laboratory studies, and the same for the scientific literature.
It is important to mention that upon reviewing the information listed hereabove, the Agency may require the applicant to provide all reports the applicant refers to, both published and unpublished.
The authority additionally emphasizes that it is the sole responsibility of the PMA applicant to determine whether the changes made to the manufacturing process, the medical device itself, or its labeling require additional reporting. Depending on the particular changes made, the PMA applicants should follow the appropriate reporting requirements.
Content of an Annual Report
In accordance with the reporting requirements, an annual report should be submitted in eCopy format. At the same time, the submission should include a single paper copy of a cover letter to be signed by the applicant. Such a cover letter should contain the following details:
- Number of the PMA,
- Name of the medical device in question,
- Name of the applicant (company name),
- The date the report has been submitted,
- Indication of a period covered by the report.
In case of changes subject to additional FDA approval, the applicant shall also indicate the appropriate reference number assigned by the authority, and also the current status of the review.
The document also outlines the changes that are not required to be reflected in the annual or other periodic reports. Such changes include, inter alia, the non-significant changes to the documentation (e.g. translations or changes to wordings used) since they do not impact the safety and performance aspects of the medical device. Thus, it would be sufficient to duly document such changes and keep the records to be able to provide them to the regulating authority upon request.
In case of important changes to be included in the scope of the annual report but do not subject to mandatory reporting under the special framework (e.g. PMA Supplement or 30-Day Notice), the applicant shall provide the following information:
- A detailed description of the changes made (it is recommended to provide such a description in the form of comparison),
- Indications of the reasons for such changes, including adverse events,
- Indications of whether the changes made create one group,
- Scientific justification confirming that the changes do not affect the safety and performance aspects and thus are not subject to mandatory reporting under the PMA Supplement or 30-Day Notice frameworks.
The information about the changes made during the reported period should be provided in a structured way. In particular, the Agency recommends dividing the information into separate tables, such as:
- Changes to the design of the medical device,
- Changes to the manufacturing process,
- Changes to the labeling.
Rationale for Changes
One of the most important concepts associated with the annual reporting relates to the rationale of changes made to the medical device itself or the manufacturing process. According to the FDA guidance, the applicant shall indicate the relevant reasons for making the changes. In particular, the applicant may refer to one of such reasons:
- Improvement or enhancement of the device,
- Elimination of a device defect identified due to the adverse event,
- A correction based on a complaint, request, or suggestion submitted by a customer,
- Changes are associated with a recall or corrective action,
- Changes are associated with the FDA Safety Alert, Public Health Notification, or warning letter.
- Changes are associated with the FDA public communications.
Besides the aforementioned information to be included in an annual report, the applicant shall also provide a summary and bibliography of know reports published in scientific literature, as well as unpublished reports related to clinical investigations or laboratory studies associated with the medical device in question. When providing such a summary, the applicant shall focus on the points associated with the safety and performance of the device. AS it was already mentioned before, the Agency may require the applicant to provide the copies of the reports a summary is based on.
Another important piece of information relates to the supply of the device in numbers. In particular, the applicant shall supplement the annual report with the details regarding the exact number of medical devices shipped or sold during the reporting period. In the case of implantable medical devices, it is also recommended to provide information regarding the number of devices implanted.
Summarizing the information provided here above, the FDA guidance on annual reports for PMA applicants describes the requirements the annual report should meet and also provides the applicants with the additional recommendations to be considered when preparing the annual or other periodic reports to ensure its completeness.
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