The article provides an overview of the policy suggested for deficiencies in medical devices.
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 following the least burdensome provisions. As described in the respective article, the least burdensome approach was introduced to reduce the regulatory burden medical device manufacturers face when placing new products on the market to expand the availability of medical devices, especially the ones based on novel technologies, to healthcare professionals and patients.
It is important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance thereto. The authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance.
The present guidance describes the approach the authority will apply when issuing requests for additional information in the context of applications for marketing approval. Provisions of the guidance and recommendations provided therein are based on the Federal Food, Drug, and Cosmetic (FD&C) Act. As explained by the FDA, the above request stands for a “deficiency”. Apart from this, the document describes the way additional information should be requested by the FDA staff, as well as the way the appropriate responses should be provided by medical device manufacturers and other parties involved. For this purpose, the document provides examples of such deficiencies and responses to be provided. Apart from this, the guidance describes in detail such aspects as distinguishing major/minor deficiencies, the way they can be prioritized by the authority, and also additional considerations.
The document also contains references to the FDA-recognized voluntary consensus standards medical device manufacturers may use to demonstrate compliance with the applicable regulatory requirements.
Deficiencies: Key Points
According to the guidance, when reviewing applications for marketing approval, the authority quite often finds out that additional information is needed for the authority to be able to decide concerning the application. This applies to all types of applications, for this guidance is collectively referred to as “marketing applications”, while the term “marketing authorization decisions” stands for the decisions to be taken by the authority. As it was mentioned before, the term “deficiencies” is used to describe additional requests the authority may issue, should additional information be reasonably needed to complete the review of the marketing application submitted by an interested party.
As further explained by the authority, the information about deficiencies could be communicated to the applicant in two ways: in the course of interactive review or by the virtue of a deficiency letter issued by the authority. In most cases, the authority follows the first approach, as it allows communication information via phone or email to avoid unnecessary delays. In such a case, there will be no need to put the review process on hold. In case of major issues, the authority will issue a deficiency letter to be served via email, resulting in a review process placed on hold until the information requested by the authority will be duly provided by the applicant. It is important to mention that depending on the application type, such a letter will be referred to as a “major deficiency letter” (for PMA and HDE pathways), or an “additional information letter” / “request for additional information” in case of 510(k) and De Novo frameworks. Concerning the situations when the review process could be placed on hold and the consequences thereof, the FDA refers to a specific guidance document dedicated to the matter.
However, the authority can also issue deficiency letters even in case minor issues are identified – for instance, in case these issues remain unresolved after being notified to the applicant via the means of instant communication. In such a case, a deficiency letter may include additional considerations that do not require a response but should be taken into account by the applicant.
Least Burdensome Approach in Brief
The document further outlines the main principles of the least burdensome approach including, inter alia, the following ones:
- Whenever the Secretary requests information to demonstrate that devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to make a substantial equivalence determination.
- Any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of the determination by the Secretary that such data are necessary to establish device effectiveness.
- In requesting additional information concerning a PMA application, the Secretary shall consider the least burdensome appropriate means necessary to demonstrate a reasonable assurance of device safety and effectiveness.
Apart from the ones outlined herein above, the authority also mentions that the role of information deriving from postmarket activities should be also taken into consideration when assessing the safety and effectiveness of a medical device in question. The information requested should be minimum required – within the scope of information that is reasonably necessary to make a regulatory decision concerning the product subject to review. At the same, the authority additionally emphasizes that the Least Burdensome Provisions do not change the standards for premarket approval or substantial equivalence.
In summary, the present guidance provides an overview of the approach to be applied concerning deficiencies in the context of the least burdensome approach. The document outlines the main principles and highlights the key points to be taken into consideration by the parties involved.
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