The article highlights the aspects related to existing submission formats and key considerations associated thereto in the context of the Voluntary Improvement Program.

FDA Guidance on Additive Manufactured Medical Devices: Material Characterization

The Food and Drug Administration (FDA or the Agency), the US regulating authority for healthcare products, has published a guidance document dedicated to the FDA’s activities and engagement with the Voluntary Improvement Program (VIP) in the context of fostering medical device improvement.

In particular, the document describes in detail the steps the authority undertakes to facilitate further technology development in the sphere of healthcare products and encourage medical device manufacturers to make efforts in this respect. 

The present guidance provides an overview of the existing legal framework and also highlights the key points to be taken into consideration 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 they 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 existing legal framework and has been agreed with the authority in advance. 

The scope of the guidance covers, inter alia, the aspects related to modified submission formats in the context of the VIP framework.

According to the guidance, the FDA continuously seeks ways to improve the efficiency of its regulatory submission process. 

In this context, the agency has initiated the aforementioned VIP to streamline submissions and address certain recommended informational requirements.

The present guidance elaborates on the modifications in three submission types in light of VIP.

30-Day Change Notice Submissions

By the applicable regulatory requirements, there is a structured format for content that should be included in a 30-day Change Notice.

However, as the VIP progresses, it is further anticipated that participants will share insights into their manufacturing processes, thus addressing some FDA recommendations concerning these change notices.

The authority further emphasizes the following key points related to the abovementioned framework:

  • The VIP assessment determines the site’s capability to oversee, maintain, and enhance its processes.
  • VIP participants are afforded a modified submission format, removing the need to provide procedures for identification, validation, and approval of manufacturing changes submitted in the 30-day notice.
  • Monitoring and control strategies for intended manufacturing modifications.
  • Explanation of change control procedures, including alterations to manufacturing or quality control instructions.
  • Execution details of purchasing control procedures, especially if the manufacturing change concerns new suppliers or contractors.
  • Descriptions about control and testing of components or raw materials.
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PMA/HDE Manufacturing Site Change Supplement

The FDA also provides guidance on content recommendations for the PMA or HDE Manufacturing Site Change Supplement.
As VIP participants provide more information, certain recommended requirements could be made redundant.

Key points related to the said frameworks include:

  • As in the previous case, the VIP appraisal assesses the site’s proficiency in managing and enhancing processes. 
  • Modifications in submission format for VIP participants include:
    • For changes involving different suppliers or contract manufacturers, there is no need to detail the supplier evaluation process.
    • Clarifications about how purchasing assessments ensure product compliance might not be necessary.
  • If manufacturing processes are consistent across sites, the modified format would exclude:
    • Descriptions of affected equipment and processes.
    • Standards for new manufacturing methods.
    • Process validation or revalidation details.
    • Environmental and contamination control measures.
    • Procedures for equipment calibration and maintenance.

Nevertheless, if these processes differ significantly from the original site, the FDA could recommend the inclusion of some aforementioned elements.

PMA/HDE Original Manufacturing Module

With respect to the PMA or HDE Original Manufacturing Module, the present FDA guidance outlines the necessary content of the respective submission. According to the guidance, the contributions of VIP participants can be vitally important in fulfilling most of these requirements.

Implications of VIP participation:

  • VIP participation ensures that medical device manufacturer complies with the applicable regulatory requirements set forth under the FD&C Act and relevant regulations. For instance, information about the design control process would have been validated.

  • VIP participants might be exempt from:
    • Submitting basic quality system procedures.
    • Sharing details if control processes or procedures have not changed since the last FDA review. This covers such areas as production and process controls, inspection measures, and more.

In all these submission types, specific identifiers such as the Device Identifier (DI) and FEI and CMMI Appraisal Numbers can be required for device description and site identification.

In summary, the Voluntary Improvement Program represents a strategic move towards regulatory efficiency.
By recognizing the potential of participants’ insights into manufacturing processes and control capabilities, the FDA can reduce redundant informational requirements, making the submission process less burdensome for manufacturers while maintaining rigorous quality control standards.

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