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Responding to Regulatory Requests for Additional Information

Oct 16, 2020 | Medical Device Testing, Regulatory, Technical Expertise

There’s been a significant increase in the prevalence of requests for additional information in recent months, particularly following ISO 10993-18:2020. Collaborating on these responses is the best way to deliver quality answers promptly, and WuXi AppTec Medical Device Testing is here to help. We aim to provide the most precise and comprehensive answers possible to help get your submission back on track.

The Handoff

To support your response, our team needs complete documentation of the request for additional information. Please provide the original wording to help our team to understand the context and language preferences. It will also indicate whether we can link to past experiences satisfying similar questions.

Typically, the original scope covers support for these requests. However, there will be cost adjustments if the provided information is incomplete, reviewers have follow-up questions or you are working against an expedited timeline.

Plan Accordingly

Transparency is vital for staying productive when responding to additional information requests. Creating a realistic timeline keeps all parties on the same page and accountable.

Our standard response time for additional information requests is five full business days, not including the day the request was received. Please note, if a customer designs their program, edits the responses provided by WuXi AppTec Medical Device Testing or submits their own response to regulators, they hold full responsibility of justification to the regulatory agency.

Other timeline factors to be aware of:

  • Retrieval of archived records is not included in the 5-day turnaround and can take up to a week to receive.
  • The initial turnaround time does not include report amendments, data processing or reprocessing.
  • The turnaround time does not include scope additions, such as additional chemistry, risk assessment or biocompatibility testing.
  • Additional customer questions or requests relating to the additional information request after the initial inquiry will reset the timeline.

Communicate Consistently

If the request for additional information is unclear or there seems to be a misunderstanding – consider requesting a call with the reviewer. Our team can join these calls if the topics in question are outside of your expertise. Consistent communication helps resolve requests more quickly and accurately. Some companies build time into their project plans in anticipation of requests to reduce the impact.

It is critical to understand the regulatory body that you are working with when addressing additional information requests. The governing agency at play can redirect which course to take when resolving requests. The following considerations can impact how your approach:

EU MDR

Requests under the EU Medical Device Regulation (MDR) may focus on understanding the testing methods. Notified Bodies (NBs) are still adjusting to the new approval process and looking to understand the study program and any justifications.

U.S. FDA

When working with the U.S. Food and Drug Administration (FDA), you may receive requests focused on the chosen application of standards and the calibration information used to satisfy those standards. These details are especially critical with chemical characterization testing as the agency has additional requirements on top of ISO 10993-18:2020.

Multi-Agency Submissions

When medicinal authorities are involved in the submission review for combination products, it can be challenging to respond to requests for additional information with answers that will satisfy both organizations. Consider the EU medicinal product authority and the EU MDR. These agencies use different, sometimes conflicting approaches. Pre-submission meetings – or even other qualified outside perspectives – can help develop common ground between the authorities in advance.

We are here to help you reach your goals in getting your product safely and successfully to market. Having realistic timeline expectations and appropriate supporting materials at the ready will progress these goals efficiently and effectively.

For more information, contact a WuXi AppTec representative today.

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