When do I need to notify authorities or get approvals… and how long does this take?
A gratuitous disclaimer up front: we at NextBeam are not regulatory experts. However, we are periodically asked by our customers what the regulatory requirements are around some of their desired changes.
To better answer this question we consulted with Beverly Whitaker, Principal Consultant at Indigo Consulting Group, LLC. Beverly has decades of experience in advising clients on the regulatory impact of changing sterilization modalities, among many other topics.
The following table is meant only as a rough guide to this process. It’s important remember that there are many factors that play a role in whether these projects move quickly or slowly, including the:
- Nature of the product for which sterilization is being changed,
- Specific experience, familiarity, and workload of the submitter,
- Reviews involved in the work,
- Quality/clarity of the written submission, and
- Supporting data/documentation
That said, here’s a general guide to what changes matter when switching modalities.
Sterilization Modality & Sterilizer Change Requirements: FDA, EU MDR, PMDA
| US FDA | EU MDR | Japan PMDA | |
|---|---|---|---|
| Changing Sterilization Modality |
For Class 2 Devices: • Switching between radiation modalities requires only internal documentation, as long as the min/max dose range remains unchanged. • If the Max/min dose must be adjusted to fit inside an E-Beam process, packaging and max dose testing must be repeated. If something changes, the manufacturer must file a 510(k). • Timeline: 90–180 days. For Class 3 Devices: • As of Q4 2024, the FDA stated it would not enforce action on EO-to-EO or EO-to-radiation changes, citing recent facility closures and anticipated EO supply constraints. • However, it's unclear whether this enforcement discretion will be formalized into policy, as no official rulemaking has been announced. |
• Every change is a significant change notice which goes to the notified body for everything sold in EU / all CE-marked products. • Notified bodies must review the change. Review can vary widely — from 2 weeks to 2 years — depending on the company’s ability to satisfy the notified body that the change has been correctly made and validated. For example, straightforward, well-aligned documentation can result in approval within a day. • Timeline: In general, approval takes less than 90 days if the supporting data and documentation describing the qualification work are aligned with standards and clearly articulated. |
• All changes require a formal application to PMDA, which will approve or deny the request. • For sterilization modality/sterilizer changes for existing devices, a Partial Change Application is used. • Similarly to the US and EU process, the application summarizes the rationale, testing, and evaluation process between changing sterilization methods or sterilizers. • As opposed to US/EU, Japan’s PMDA has a draconian requirement that everything must be handled in-country, e.g. modality change data must be submitted by the company’s Japanese-based entity and representative, adding cost. • Timeline: The approval time can vary widely, but 4–6 months is a rough estimate. |
| Changing Sterilizer |
For Class 2 Devices: • No notification required (internal filing only). For Class 3 Devices: • Notification and approval are required. |
As you’ll note, the US is most liberalized in terms of relying on the manufacturer to make changes without approval when supported by solid testing data and documentation.
The EU relied on notified bodies to do the work of reviewing applications – scheduling these can vary widely.
And, finally, Japan’s PMDA is the most conservative of the three, with partial change review times in the 4-6 month range. For all, a “par” time for response by reviewers would be in the 3-6mo timeframe.
Supporting Your Transition
The above overviews and estimates are not intended to substitute for the attention of a qualified and experienced regulatory department or consultant on your specific project.
As always, we at NextBeam are happy to assist with these transfers by rapidly working with customers to define and execute testing protocols such that supporting data for these change applications can be rapidly and confidently generated. Contact us for more information.
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