The new article covers specific aspects related to the Voluntary Improvement Program and regulatory procedures associated thereto.
The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties involved regarding the regulatory approach suggested. Thus, the provisions described in the present draft guidance could be subject to changes due to new information becoming available to the authority.
The Agency will accept comments within two months from the date the document has been initially published. Once finalized, the document will provide additional recommendations and clarifications on the matter.
Due to their legal nature, guidance documents do not introduce any requirements themselves. The approach described therein should be taken into consideration by the medical device manufacturers or other parties engaged in operations with medical devices in the context of achieving and sustaining compliance with the applicable regulatory requirements set forth by the current legislation. Additionally, the Agency states that an alternative approach could be applied, provided such an approach has been approved by the authority in advance.
Thus, the present FDA guidance provides suggested recommendations for the design of feasibility and early feasibility clinical studies for certain medical devices. These recommendations are mostly based on existing clinical practice guidelines.
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 Voluntary Improvement Program (VIP), a special regulatory framework intended to facilitate the improvement of medical devices already placed on the market. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by the medical device manufacturers in this respect. It is important to mention that FDA guidance documents are non-binding in their legal nature, and are not intended to introduce new rules or impose new obligations. Moreover, 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. The document outlines the eligibility criteria and also describes the procedure to be followed by an interested party to apply for inclusion in VIP and be able to benefit from the opportunities the framework provides.
The authority also provides additional clarifications regarding the scope of information to be included in the submissions to facilitate the process and ensure the authority has sufficient data regarding the device in question. In particular, the authority expects to receive detailed information regarding the manufacturing processes, as such information will be communicated to the FDA in the context of the Voluntary Improvement Program and cooperation associated thereto. Availability of this information will allow the authority to provide additional recommendations regarding the scope of information to be provided when applying for marketing approval for the device subject to review. Hence, VIP participants will be able to streamline the regulatory procedures associated with applying for marketing approval and benefit from the least burdensome approach. The document further describes the approach to be applied concerning various submission types.
30-Day Change Notice Submissions
First of all, the authority mentions that the general recommendations regarding the scope of information to be included in the 30-Day Change Notice are provided in the respective guidance document issued by the FDA. At the same time, the authority expects that the information shared in the context of participation in the Voluntary Improvement Program will provide additional details regarding the control capabilities and quality control measures developed and implemented by the medical device manufacturer. Since the authority would already have certain information necessary for the completion of the review, the applicants following the VIP framework would be able to use a modified submission format which requires less information to be included. For instance, it would be allowed to file the submission without providing such documents as:
- A summary of the procedures established for the identification, documentation, validation, review, and approval of the manufacturing changes submitted in the 30-day notice;
- A description of how you will monitor and control any manufacturing process you intend to change;
- A summary of how purchasing control procedures were implemented to evaluate any new supplier or contractor if the manufacturing change involves changes in suppliers of components or raw materials that are critical to the performance of the device, or the use of a new contractor for a manufacturing process or quality control testing;
- A description of the type and extent of control to be exercised over the component or raw material, including specifications for the incoming material and a description of incoming acceptance activities.
The document also mentions that the description of a medical device in question could be replaced by the Device Identifier.
PMA/HDA Manufacturing Site Change Supplement
Another application type for which certain changes could be made is a PMA or HDE Manufacturing Site Change Supplement. As in the case with the submission type described hereinabove, the general requirements regarding the context of the submission are provided in a separate guidance document dedicated to the submission. Since in the course of cooperation within the VIP framework the authority will obtain certain information about the manufacturing facilities, processes, and control measures, the scope of information required could be reduced. In particular, the document outlines the details that could be excluded from the submission, provided they are consistent for all manufacturing sites involved. Such details include, inter alia, the following ones:
- A description of the equipment and processes that would be affected by the site change;
- A list of any standards used in the new manufacturing processes, if applicable;
- The process validation or revalidation procedures (and reports, if applicable);
- The procedures for environmental and contamination controls if such conditions could adversely affect the device;
- The procedures for incoming acceptance activities at the subject manufacturing site, if different from the procedures contained and approved in the original PMA.
PMA/HDE Original Manufacturing Module
The document also provides the details regarding the modified submission format for the PMA or HDE Original Manufacturing Module submissions, the general recommendations for which are provided in the FDA guidance dedicated to the quality system information to be provided when applying for marketing approval. In particular, the authority mentions that some of the documents are to be provided only in case there were changes to the underlying procedures and processes. This approach could be applied to such documents as:
- Production and Process Controls;
- Inspection, Measuring, and Test Equipment;
- Receiving Acceptance Activities;
- Final Acceptance Activities;
- Nonconforming Products;
- Complaint Files;
As in the case with other submission types, it is allowed to replace device information with the Device Identifier (DI).
In summary, the present FDA draft guidance provides a detailed overview of the regulatory framework associated with the Voluntary Improvement Program and describes the way the participants could benefit from following the appropriate pathway. The document clarifies the scope of information the authority expects to receive in case of different submissions and also highlights the most important aspects to be considered.
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