The article describes in detail the way the medical device manufacturer may apply for exemptions from general reporting requirements, as well as the information to be included in the appropriate request.
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 document is intended to assist medical device manufacturers and other parties involved in operations with medical devices in ensuring compliance with their obligations on reporting adverse events associated with the products placed on the market. In particular, the guidance provides additional clarifications on applicable regulatory requirements, as well as recommendations to be considered to achieve and sustain compliance thereto. However, the authority also mentions that an alternative approach could be applied, provided such an approach is in line with the provisions of existing legislation and has been agreed with the authority in advance.
The document clarifies, inter alia, the approach to be applied in specific cases, and the way various aspects should be treated.
Information to be Submitted
According to the guidance, an entity responsible for a medical device (usually – its manufacturer) should make reasonable efforts to collect information about the event that occurred. In this respect, the authority refers to the concept of “good faith efforts” which describes the approach to be applied by the manufacturer when attempting to obtain additional information about the reportable event. As further explained by the FDA, the manufacturer shall duly document all the attempts made, and the results achieved. The information to be collected by the manufacturer should be sufficient to identify the root cause of an issue and the way the device in question contributed to it. Sometimes the information additionally collected by the manufacturer could even impact the way the report should be treated based on the severance of consequences. Once the report is submitted, the authority will assess, inter alia, the efforts made by the manufacturer to determine whether they are sufficient and could be considered “good faith efforts”.
Moreover, the authority reserves the right to request the manufacturer to provide additional information, should it be reasonably necessary to assess all important aspects of the case. In such a case, the FDA will send the appropriate written notification outlining the additional information required, as well as the purpose for requesting it, and the date when the authority expects to receive it. The authority also mentions that the verbal requests (if any) would be followed by a written confirmation. The aforementioned notice will also contain the details on the way the response should be provided.
Report Form and Exemptions
Following the applicable legislation, all written or electronic MDR reports, including any supplemental reports or requested additional information must be in English. The appropriate requirement is set forth by 21 CFR 803.13(a).
Under the general rule, reporting requirements should be followed by all the parties involved in operations with medical devices. However, additional exemptions could have a place for certain categories, namely:
- Licensed practitioners who prescribe or administer devices intended for use in humans, and who manufacture or import devices solely for use in diagnosing and treating persons with whom the practitioner has a “physician-patient” relationship;
- An individual who manufactures devices intended for use in humans solely for such persons’ use in research or teaching and not for sale, including any person who is subject to alternative reporting requirements under the Investigational Device Exemption (IDE) regulation (21 CFR Part 812), which requires the reporting of all adverse device effects; and
- Dental or optical laboratories.
As further explained by the FDA, an interested party may ask for an exemption, variance, or alternative form of reporting. The appropriate request referring to some or all reporting requirements should be submitted by an interested party in writing. Once received, the report will be reviewed by the Agency, which is entitled to (a) grant the special allowance requested, (b) deny the request in whole, or (c) in part. Furthermore, the authority also mentions that it is allowed to grant an exemption, variance, or alternative form of reporting even in case it was not explicitly requested by a party responsible for a medical device. At the same time, the FDA is also entitled to impose additional reporting obligations, should it be necessary to ensure public health protection, or revoke/modify the allowance granted previously, should it be found reasonable for the same purpose. The aforementioned variations to the reporting form could be related to the timing of report submission or the scope of data to be provided. As described in the example provided by the FDA, it could be possible to agree on a different reporting schedule.
The authority additionally emphasizes that the party responsible for a medical device should strictly follow the way of action prescribed by the FDA in the respective response letter, while in case of discrepancies with the general medical device reporting requirements the specific conditions prescribed by the Agency in the letter should prevail.
The way an interested party may apply for an exemption is outlined in 21 CFR 803.19(b), while additional clarifications are provided in the respective guidance documents dedicated to the matter. As further explained by the FDA, a request for an exemption should include, inter alia, the following details:
- Firm identification, including reporting site registration number and the name, address, and telephone number of the contact person;
- Type of exemption requested. For example:
- A total exemption from the MDR requirements, or
- A request to designate an authorized reporter for manufacturer/importer or specifications developer/contract manufacturer, where both entities are subject to reporting;
- Type of events involved (e.g., serious injuries, malfunctions);
- Device identification such as brand name, model, or the catalog number and product classification code;
- Description of the specific type of device problem(s) or adverse event(s) [the applicant] would like [the FDA] to consider for the exemption or alternative reporting;
- Justification for the request, including why [the applicant] believe[s] FDA does not need to receive the information required by 21 CFR 803.52 for the affected events; and
- Estimated number of MDR reports filed annually that will be affected by this exemption.
As it was mentioned before, such a request should be submitted in writing.
In summary, the present FDA guidance provides additional clarifications regarding the regulatory requirements related to medical device reporting. The document describes the way of action in specific cases, such as requesting an exemption.
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