The new article describes in detail the aspects related to the content of deficiency letters, their review, as well as the way the authority expects the industry to respond to such letters.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to developing and responding to deficiencies in accordance with the least burdensome provisions. The document provides additional clarifications regarding the existing regulatory requirements, as well as recommendations to be taken into consideration in order to ensure compliance thereto. In particular, the guidance is dedicated to the matters related to the actual implementation of the least burdensome approach introduced in order to reduce the regulatory burden and expand the availability of medical devices, especially the ones based on novel technologies. At the same time, it is important to mention that provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing regulatory framework and has been agreed with the authority in advance.
For the purpose of the guidance, deficiencies stand for requests the authority may issue in case additional information is reasonably needed in order to finalize the review of an application for marketing approval related to a medical device intended to be marketed and used in the US. Under the general rule, deficiencies are communicated to the responsible parties by the device of deficiency letters the FDA will issue. The scope of the guidance describes in detail the approach the authority will apply when issuing such letters, as well as the way the authority expects the parties involved to provide their responses to these letters.
Content and Format
The present FDA guidance describes, inter alia, the key points related to the content and format of deficiencies to be communicated to medical device manufacturers and other parties responsible for medical devices intended to be placed on the US market. According to the guidance, in order to ensure the proper efficiency, a deficiency should include the following elements:
- What was submitted: Acknowledgement of the information submitted by the applicant, including references to sections, page numbers, or tables where appropriate.
- Identification of a specific issue or concern with information that was submitted, is missing, or is inadequate.
- Statement of the basis for the deficiency that includes the effect or impact of the specific issue or concern on the marketing authorization decision, and, when available, applicable, and relevant, a specific reference.
- Explicit request for the additional information needed to address the issue and potential alternative ways of satisfying the issue, if applicable.
As further explained by the authority, a letter issued with respect to the deficiencies identified could include several statements within the scope of each of the points listed herein. The order of the elements could also be different, as this will not impact its legal power – the actual order used will be based on the particular circumstances of a specific case. Apart from these elements, a deficiency letter issued by the authority may include an introductory paragraph, as well as other elements intended to improve the legal clarity of the document and ensure correct interpretation of the aspects highlighted therein, such as a preface for a group of deficiencies related to the same matter. The guidance also provides several examples of deficiency letters demonstrating the way they could be structured.
Deficiency Letters: Review
The scope of the guidance also covers the aspects related to the review of deficiency letters. In accordance with MDUFA V Commitment Letter, deficiency letters will undergo supervisory review prior to issuance to ensure the deficiencies cited are relevant to the marketing authorization decisions (as it was mentioned before, the least burdensome principles establish that the authority should request only the additional details that are reasonably necessary to complete the application review). Furthermore, before sending a deficiency letter out to the party responsible for a medical device in question, the authority will make sure it contains all the four elements listed herein. Furthermore, the authority additionally emphasizes the importance of prioritizing the deficiencies that are the most critical so that the party responsible for a medical device is able to focus on them (as it was mentioned before, a deficiency letter could contain information about deficiencies that are less important and do not prevent the authority from taking a regulatory decision, so the authority does not expect such deficiencies to be responded). For this purpose, the deficiencies that are the most important should be listed first.
Industry Responses: Suggested Format
In order to assist medical device manufacturers and other parties involved in complying with the regulatory requirements described in the guidance, the document also provides recommendations regarding the format of the responses the authority expects to receive from the industry. Under the general rule, applicants are obliged to provide complete responses within the timeframes specified therein. In particular, when preparing a response, the following format is to be used:
- Restate the identified Agency issue; and
- Provide one of the following:
- The information or data requested;
- An explanation why the issue does not affect or impact the marketing authorization decision; or
- Alternative information and an explanation describing why the information adequately addresses the issue.
Apart from this, the authority also encourages the parties involved to indicate a deficiency number. In case of a response provided to a previous request from the authority, the appropriate references are to be provided as well. Should a response include multiple elements, it could be reasonable to structure it as a table, as this will simplify the review process.
In summary, the present FDA guidance provides additional clarifications regarding the deficiency letters the authority may issue when additional information is reasonably needed in order to assess the safety, quality, and effectiveness of medical devices intended to be placed on the market. The document highlights the key points to be considered by the applicants when providing responses to deficiency letters to make sure all the questions raised by the authority are duly addressed.
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