The new article highlights the aspects related to the main principles on which the least burdensome approach is based, and also describes the key points related to the said principles.
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 provisions. The document provides an overview of the applicable regulatory requirements, as well as recommendations to be taken into consideration by all the parties involved to ensure compliance thereto. In particular, the document describes the least burdensome approach introduced to reduce the unneeded regulatory burden and streamline the regulatory procedures and processes related to placing new medical devices on the market. At the same time, provisions of the guidance are non-binding, 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 underlying legislation and has been agreed with the authority in advance.
The scope of the guidance covers any products that meet a definition of a medical device (including devices that are the parts of combination products). In terms of operations, the guidance covers both premarket and postmarked activities that are subject to regulation under the framework of the medical device. As further explained by the FDA, the present guidance should be applied concerning:
- Premarket submissions, including premarket approval applications (PMAs), premarket notification (510(k) submissions), De Novo classification requests, humanitarian device exemption (HDE) applications, and investigational device exemption (IDE) applications;
- Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications;
- Additional Information and Major Deficiency Letters;
- Q-Submissions, including Pre-Submissions;
- Informal or interactive inquiries regarding device development;
- Panel review and recommendations;
- Postmarket surveillance, including Medical Device Reports (MDRs) and Post-Approval Studies;
- Reclassification and 510(k) exemptions;
- Guidance documents and their application;
- Compliance-related interactions;
- Regulation development.
As it was mentioned before, the least burdensome approach provides that the information to be submitted by an interested party should be limited to a minimum the authority reasonably needs to assess the aspects subject to review under the applicable regulatory requirements. At the same time, it does not impact the applicable standards and requirements to be met to ensure the proper quality, safety, and performance of medical devices intended to be marketed and used in the US.
The document outlines the key guiding principles to be followed in the context of the regulatory burden associated with placing new medical devices on the market. These principles include the following ones:
- FDA intends to request the minimum information necessary to adequately address the regulatory question or issue at hand.
- The industry should submit material, including premarket submissions, to FDA that is least burdensome for FDA to review.
- FDA intends to use the most efficient means to resolve regulatory questions and issues.
- The right information should be provided at the right time (e.g., just-in-time data collection) to address the right questions.
- Regulatory approaches should be designed to fit the technology, taking into account its unique innovation cycles, evidence generation needs, and timely patient access.
- FDA intends to leverage data from other countries and decisions by, or on behalf of, other national medical device regulatory authorities to the extent appropriate and feasible.
- FDA intends to apply the least burdensome principles in international medical device convergence and harmonization efforts.
The authority also mentions that it intends to provide the best customer service possible, as it will also help to reduce the unneeded regulatory burden and make all the procedures more smooth and efficient, ensuring that the patients and healthcare providers have timely access to safe and efficient medical devices based on the most advanced technologies. For this purpose, the authority takes all the steps to make its communications clear and concise, issues policies and guidelines dedicated to specific regulatory matters, and provides detailed responses once requested by industry representatives concerning specific cases. At the same time, the industry representatives are also expected to contribute to the said process by submitting clear requests and completing applications that are in line with all the applicable requirements. Once combined, the efforts paid by both the authority and industry representatives would improve the overall process and make the regulatory activities associated with medical devices more efficient.
The authority also provides additional clarifications regarding some of the principles listed hereinabove. For instance, when it comes to the submission of information by the parties interested in placing their products on the market or obtaining other services to be provided by the FDA, the authority expects them to submit well-organized, clear, and concise information, and not submit information unrelated to the regulatory decision to FDA. The scope of information to be submitted should be in line with additional clarifications provided by the authority by the virtue of separate guidance documents addressing the most common issues industry representatives may face. At the same time, the authority will make sure the review methods and approaches it applies are the most efficient ones for the nature of the device in question and the regulatory request associated thereto. The authority will also combine different approaches in terms of cooperation and interactions with industry representatives to ensure such interactions are as efficient as possible. The authority may request additional information reasonably needed to complete the assessment of actors detailing the quality, safety, and effectiveness of a medical device in question, and expects the applicant to respond and provide the information requested on time.
In summary, the present FDA guidance outlines the key principles the least burdensome approach is based on and also explains each of them in detail. The document describes the steps each party should take to ensure the efficiency of the regulatory processes and procedures related to medical devices.
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