The new article describes in detail the aspects related to timing for regulatory procedures in the context of the least burdensome approach.
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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 the least burdensome approach introduced to reduce the regulatory burden related to placing new medical devices on the market. The purpose the authority intends to achieve in such a way is to ensure and expand the availability of medical devices, especially the ones based on novel technologies, and also to make the regulatory procedures more efficient. At the same time, it is important to mention that the present FDA guidance is non-binding, nor is 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 considered to ensure compliance thereto. The FDA explicitly states that an alternative approach could be applied, provided such an approach is in line with existing legislation and has been agreed with the authority in advance.
Information Needs: Finding the Balance
According to the guidance, a proper balance is to be established between premarket and postmarket information needed to ensure that reasonably needed information is being collected at a proper time. As set forth by the applicable legislation, the authority should consider the role of postmarket information when deciding on the least burdensome means of demonstrating a reasonable assurance of safety and effectiveness for PMAs. The said balance is important for any regulatory matters related to medical devices intended to be marketed and used in the US.
The document further describes the way the said approach should be applied. For instance, the applicable legislation permits medical device manufacturers to make certain changes to medical devices already placed on the market, as well as to the labeling thereof, without being subject to reporting obligations set forth under section 510(k) of the FD&C Act. In such cases, a risk-based approach should be applied – the changes should be assessed in the context of the impact they could potentially have on the overall safety and effectiveness of a medical device. In this respect, the authority refers to the guidance documents dedicated to changes to existing medical devices and software changes.
As further explained by the authority, according to the least burdensome principles, it intends to request only the information reasonably needed to make a specific regulatory decision. Furthermore, each time requesting such information, the authority will take into account the time the manufacturer will need to fulfill such request. In certain cases, the authority may find it acceptable for such information to be provided at a postmarket stage, as long as the safety and proper performance of a medical device in question are duly assured. For this purpose, the authority will consider the possibility of relying on such controls as post-approval studies and MDR. It is further stated that in some cases, FDA has determined that premarket review is not required to reasonably assure a device’s safety and effectiveness – for example, some medical devices that are exempt from premarket review rely on the QS Regulation and other postmarket controls to reasonably assure their safety and effectiveness. As explained by the FDA, some of the matters related to the safety and effectiveness of a medical device could be subject to assessment after the device is placed on the market without exposing patients to additional risks. This also applies to the assessment of long-term outcomes.
The authority mentions that in line with the approach described herein above, it has already reviewed 200 product codes to determine their eligibility for a premarket/postmarket shift. As a result, some of the product codes were reclassified, consequently, the scope of mandatory information the parties involved should provide for such devices when applying for marketing approval has been reviewed and limited. For instance, some of the Class III (premarket approval) products were reclassified to Class II (special controls) – e.g., salivary simulators or single-use internal condoms. The authority also publishes information about the medical devices subject to reclassification on a website to make it available to interested parties. In this respect, the document also refers to the appropriate guidance document Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.
Another important aspect described in the guidance relates to the testing medical devices should be subject to within their lifecycle. According to the document, in the case of Investigational Device Exemption (IDE) applications, the timing should be determined using the device evaluation strategy for early feasibility studies that could be based on a limited scope of nonclinical data in comparison to a scope required for traditional feasibility or pivotal study. It is further stated that the goal of the FDA’s policy on IDEs for early feasibility studies is to facilitate the initiation of clinical studies in the United States earlier in the device development process than what has historically occurred while ensuring the study has acceptable human subject protection measures for its participants. Additional details regarding this matter are described in the FDA guidance document Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.
In summary, the present guidance describes the approach the authority intends to apply when determining the proper timing for regulatory actions. For instance, the document explains how the authority will decide on whether additional information is to be requested, or determine the stage when additional testing is to be performed.
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