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 balancing premarket and postmarket data collection for medical devices subject to premarket approval. The current version of the document was issued in April 2015.

It is important to mention that due to its legal nature, the guidance does not introduce any new rules or requirements but provides additional clarifications and recommendations to be considered by the parties involved with regard to the applicable regulations. The Agency also mentions that an alternative approach could be applied, provided such an approach complies with the relevant regulatory requirements and has been approved by the authority in advance.

Regulatory Background

The present document describes certain aspects related to data collection performed in the context of premarket approval applications (PMAs). In particular, the guidance outlines how postmarket information could be used to supplement data relating to safety and effectiveness collected during the premarket stage. The approach described in the document is important because it simplifies the regulatory procedures for placing a new medical device on the market. Thus, it ensures and expands the availability of novel medical devices for healthcare professionals and patients by making the premarket review process more efficient and transparent and reducing the efforts to be paid by the FDA when reviewing the application. 

The regulatory requirements for data collection addressed in the document are prescribed by the Federal Food, Drug, and Cosmetic (FD&C) Act, which is the core US regulation in the sphere of medical devices. The scope of the guidance also covers additional regulations and policies related to the matter. 

Under the present guidance, the FDA describes how it will review postmarket data in the context of premarket approval applications and benefit-risk assessment. The approach described in the document could also be applied for special frameworks, such as De Novo Classification requests or Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need. 

As mentioned, the FDA guidance does not impose an additional regulatory burden for the parties involved but provides important clarifications on the matter. The recommendations provided in the guidance could be subject to changes due to amendments to existing laws and regulations. 

In order to fulfill its functions, the FDA shall establish the proper balance between facilitating medical device innovations and ensuring any and all medical devices allowed to be marketed and used in the US meet all applicable regulatory requirements in terms of safety and effectiveness. 

The Agency acknowledges that it could be difficult to identify and assess certain risks associated with the medical devices during the premarket review. This happens due to the length and complexity of the studies to be performed in order to collect sufficient information. The Agency also states that the results obtained from the controlled clinical studies are not always representative when compared to the actual real-world clinical practice. Thus, in certain cases, the FDA accepts shifting focus from premarket data to postmarket data collected in the course of the actual use of a medical device. In particular, the authority states that getting the right balance between premarket and postmarket data collection – especially, where appropriate, a greater reliance on postmarket collection, including real-world data collection, can reduce the extent of premarket data collection and directly impact when patients will have access to high-quality, safe and effective medical devices. But greater reliance on postmarket data collection could undermine patient safety if the necessary and timely data collection does not occur. 

The use of postmarket controls in the context of preliminary review associated with the premarket application approval is described by Section 512(a)(3)(C). The regulation prescribes the following approach to be applied: 

In making a determination of a reasonable assurance of the effectiveness of a device for which [a premarket approval application] has been submitted, the Secretary shall consider whether the extent of data that otherwise would be required for approval of the application with respect to effectiveness can be reduced through reliance on postmarket controls. 

According to the position of the authority, the increased use of postmarket data instead of data collected during premarket activities could be useful for ensuring and expanding the availability of novel medical devices for the patients. The FDA further describes particular cases when it is acceptable to rely on data collected during the postmarket stage. The Agency additionally emphasizes that such an approach could only be applied provided there are efficient postmarket monitoring measures in place to ensure the safety and effectiveness of the products made available for healthcare professionals and patients. 

New Approach in Detail

The Agency outlines the main aspects associated with the special regulatory framework described herein, namely:

  1. The least burdensome approach prescribes that the authority shall request only the data reasonably “necessary to establish device effectiveness.” Under this principle, the FDA requests associated with a premarket approval application should not create an unnecessary regulatory burden for the applicant, so their scope should be limited to the data and information the authority reasonably needs to assess the factors related to the safety and effectiveness of the medical device in question. Thus, the scope of postmarket data to be collected could also be considered when determining the scope of data to be provided during premarket review. In particular, references to postmarket data to be collected at later stages could be used to reduce the scope of data to be provided during the initial premarket review. 
  2. Benefit-risk analysis. According to Section 513(a) of the FD&C Act, FDA determines whether PMAs provide a “reasonable assurance of safety and effectiveness” by “weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use”, among other relevant factors. In this regard, the FDA shall ensure the potential benefits outweigh any potential risks associated with the medical device. Such a determination should be based on reliable scientific evidence. The applicable regulation also states that there should be no unreasonable risks arising when the medical device is used for its intended purpose. 

Postmarket Data 

According to the regulatory approach described in the FDA guidance, if the premarket information provided by the applicant in the course of the initial premarket approval application is insufficient to evaluate all important aspects associated with the safety and effectiveness of the medical device subject to review, the Agency is allowed to consider relying on postmarket data to be collected, provided all necessary controls are in place in order to to ensure continuous safety and effectiveness of the medical device. 

In summary, the present guidance provides additional clarifications on how postmarket data could be used in the context of premarket approval application review. The document highlights the most important aspects associated thereto, as well the main principles such use should be based on. 


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