FDA Seeks to Streamline Medical Packaging Sterilization PaperworkFDA Seeks to Streamline Medical Packaging Sterilization Paperwork

During its Medical Device Sterilization town hall on October 9, the US Food and Drug Administration shared a recap of its latest sterilization-related activities. The meeting is part of an ongoing series to support the agency’s multi-pronged approach to reducing reliance on ethylene oxide sterilization.

PCCPs cut time and paperwork.

During the town hall, sterilization and regulatory subject matter experts addressed the purpose and general content of PCCPs and explored sterilization-related modifications that may be appropriate for a PCCP.

A PCCP allows manufacturers to provide documentation in their marketing submission that details specific future modifications that can be made to the device. Panelists pointed out that a PCCP can only be reviewed and established as part of a marketing authorization (510(k), premarket approval (PMA), or de novo).

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Once the PCCP is authorized, the manufacturer is able to validate and implement those modifications from the authorized PCCP without the need for a new marketing submission.

According to FDA, the value of the PCCP is that manufacturers can iterate their device more quickly and reduce the need for subsequent marketing submissions for each of those planned modifications included in the PCCP. Reducing the number of new submissions for modifications in the future is also less burdensome for FDA.

FDA recommends reviewing the PCCP draft guidance, which outlines three key elements that should be included in a PPCP: the description of modifications, the modification protocol, and the impact assessment.

FDA regularly updates its sterilzation-related activities. (See bottom of this article for links.)

Sterilization-related modifications for PCCPs.

During the town hall, FDA highlighted examples of modifications related to sterilization that may be appropriate for future submissions.

For PCCP modifications in a 510(k), FDA generally believes changes in sterilization, packaging, transport, or expiration dating may be appropriate when using well-established methods. PCCP modifications in a PMA submission should generally be limited to minor changes in sterilization, packaging, transport, and expiration dating.

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FDA provided the following example of an appropriate PCCP modification: A change to a different, non-novel sterilization method (for example, from a Category A to a Category B method) for a non-absorbable, polyethylene surgical suture. An example of an inappropriate PCCP modification would be a change from a device labeled for single use only to a device labeled as reusable.

In the PCCP draft guidance, FDA proposes that PMA manufacturing changes or changes appropriate for a 30-day notice may be appropriate for inclusion in a PCCP. Two examples of changes appropriate for a 30-day notice include a change to a test site for sterilization test samples where the specifications are unchanged, and the second example is a change to the aeration time used at a sterilization site.

FDA wants to hear from you.

For manufacturers interested in submitting a PCCP for their device, FDA recommends early interaction with the agency. To date, FDA has not authorized a device with a PCCP related to sterilization modifications but the agency is eager to hear from manufacturers that are considering how to propose a PCCP in this space and encourages a pre-submission to receive feedback on proposed PCCPs.

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