The new article describes the particular way the least burdensome provisions should be applied to facilitate and streamline the regulatory processes associated with placing medical devices on the US market.
The Food and Drug Administration (FDA or the Agency), the US regulatory authority in the sphere of healthcare products, has published a guidance document dedicated to the least burdensome approach the authority intends to apply to ensure and expand the availability of medical devices, especially the ones based on novel technologies, by reducing the unneeded regulatory burden the parties involved may face when applying for marketing approval. In particular, the document provides additional clarifications regarding the least burdensome provisions contained by existing regulations, as well as recommendations to be followed by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, 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 scope of the guidance covers, inter alia, the means intended to make the overall regulatory procedures more efficient by streamlining processes and reducing administrative burden. Apart from this, the document describes the approach to be applied by the authority in the context of smart regulation and global harmonization. It is stated that the authority has already implemented several policies and practices intended for the above purpose.
According to the guidance, the inclusion of multiple devices or indications within a bundled marketing submission or the use of dual submissions can limit redundant submission and review of regulatory information by the FDA and industry. Thus, bundling could be applied to applications related to generic types of medical devices. In such cases, all the regulatory matters will be assessed at once. In this respect, the authority refers to a separate guidance document Bundling Multiple Devices or Multiple Indications in a Single Submission which describes the eligibility criteria to be applied when determining whether bundling is possible in a specific case.
One of the main concepts used to simplify and facilitate the regulatory procedures related to placing new medical devices on the market under the 510(k) framework is substantial equivalence. The said pathway allows medical device manufacturers to provide evidence demonstrating the substantial equivalence of a new product to a similar medical device already placed on the market (predicate) instead of submitting a complete application. As further explained by the FDA, there are two ways to demonstrate substantial equivalence under the New 510(k) Paradigm:
- The Special 510(k) program; and
- The Abbreviated 510(k) program.
When demonstrating substantial equivalence, medical device manufacturers may refer to FDA-recognized voluntary consensus standards; while concerning the two new pathways the authority refers to a separate guidance document dedicated thereto.
According to the applicable reporting requirements, PMA annual reports can be used to summarize design, labeling, and manufacturing changes that do not affect safety and effectiveness. The said reporting requirements are described in detail in the respective FDA guidance as well. The authority also mentions that the materials related to the matters outlined herein above could be submitted in electronic format by the virtue of the eSubmitter tool and Electronic Submission Gateway.
Medical Device Development Tools (DDTs)
As explained by the FDA, an MDDT is a method, material, or measurement used to assess the effectiveness, safety, or performance of a medical device; MDDTs are tools that can be qualified and used to streamline device development and regulatory evaluation. Once the qualification has been completed successfully, the MDDT can be used in the context of regulatory decision-making concerning medical devices intended to be marketed and used in the US to reduce both the costs associated with the medical device development and the time needed for the authority to complete the review. According to the guidance, examples of such tools include, inter alia, patient-reported outcome questionnaires.
Medical Device Reporting
As it was mentioned before, medical device reporting constitutes an important part of the obligations of a party responsible for a medical device placed on the market. Thus, the FDA intends to take additional steps to reduce the regulatory burden associated thereto as well. For instance, the Electronic MDR (eMDR) system has been developed and implemented by the authority to simplify the process of preparation, and submission of the reports related to medical devices and their subsequent review by the authority. Hence, such an approach allows reducing significantly the data entry burden the responsible parties face and also accelerates the processing of the reports submitted.
Apart from this, in case an entity does not qualify for an exemption from mandatory reporting, a request for alternative summary MDR reporting can be submitted, while the regulating authority may grant an alternative or full or partial exemption from the MDR regulations. The document provides an example of when a medical device manufacturer may request permission to submit reports on a quarterly, semiannual, or annual basis, while under the general rule such a report should be submitted within 30 calendar days from the date the responsible party becomes aware of an incident that meets the applicable reporting criteria. The request the responsible parties may file could also be related to the scope of data to be included in reports the authority expects to receive. An alternative reporting approach provides that only certain adverse events are subject to reporting. The authority may also allow a manufacturer to submit a summary report quarterly.
In summary, the present FDA guidance describes the approach the authority intends to apply to streamline and facilitate the regulatory procedures related to medical devices, and also to expedite such procedures, and reduce the time necessary for the product to be placed on the market. The document outlines specific measures to be implemented for the said purpose and also explains the way medical device manufacturers and other parties involved may benefit from them.
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