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Mitigating the Impact of an FDA Warning Letter

FDA warnings require immediate attention, a decisive plan and action. Responses require sound justification that meets today’s regulatory requirements. Preclinical safety responses require a scientific rationale to support the product’s overall safety verification.

The sense of urgency to respond to a warning is paramount, especially with commercialized products. The goal is to respond to regulatory inquiries in a timely manner, ensuring the product can ship to meet demand and preserving a seamless supply chain to your end users.

This case study highlights how WuXi AppTec responded to a customer’s FDA warning letter. Our scientists and technical experts collaborated to design studies to ensure reproducibility and product safety. Our approach met the regulatory expectation and, ultimately, our customer was able to release the commercialized product

Unknowns are Unacceptable

Unfavorable risk assessments cost medical device manufacturer’s time and money. WuXi AppTec Laboratory Testing Division Medical Device Platform is the gold-standard in materials characterization with complete chemical identification—to us, unknowns are unacceptable. Download and read the free white paper from WuXi AppTec, “Unknowns are Unacceptable.”

Articles

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Med Device Online: Preparing For MDR? Start With A Gap Analysis

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Medical Design Briefs: Got Your Game Plan? The OEM Playbook to Navigating Pre-Clinical Device Testing Under MDR & ISO 10993-1

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Medical Design & Outsourcing: Pre-clinical medical device testing under ISO 10993-1 and the MDR

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MD+DI: Is Your Testing Program Ready for the EU MDRs?

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MedTech Intelligence: How to Plan for EU MDR So You Can Sleep at Night

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On Demand Videos

Considerations of Reprocessing Study Design

A cleaning validation, whether for a multi-use or third-party reprocessed device, is not standardized; we address each device or device product family independently. Following the instructions for use (IFU) of your device, the developed study protocol simulates clinical use and variables are adjusted to ensure worst-case conditions are established.

 At WuXi AppTec, we always consider the following factors:

  • Your unique product and its instructions for use (IFU)
  • The function of the device’s design
  • The cleaning complexity
  • Device materials and device criticality


Our accumulated soil evaluations include simulation of the following:

  • Clinical cycle for all points of contact such as before, during and after clinical use
  • Dry time during transport or staging
  • Cleaning process
  • Sterilization or disinfection process

 

Our assessment of soil accumulation by simulating clinical application provides you with a level of confidence on the stacked effects of reprocessing and their potential impacts on terminal disinfection or sterilization.

The Regulatory Consultant’s Guide to ISO 10993-1, -17 & -18 Updates & What to Look for in Chemistry Reports

With changes to ISO 10993-1, chemical testing is becoming more important than ever to support a medical device’s safety for market. Medical device manufacturers can no longer rely on biocompatibility testing alone to obtain regulatory approval.

Emphasizing the importance of complete chemical information to your clients will give both you and them higher confidence that they can avoid unnecessary and costly regulatory delays.

Regulators will require detailed chemical information to support the direction of biocompatibility test plans. The expectation is that all chemicals are identified. If unknown chemicals are listed in a chemistry report, your clients should be prepared to hear from regulators again – and with the shrinking number (and capacity) of notified bodies, this is an especially problematic scenario.

Join WuXi AppTec’s regulatory experts Sandi Schaible, Senior Director of Analytical Chemistry, and Mark Cabonce, Director of Technical & Regulatory, to learn the ins and outs of ISO 10993 Part 1 and upcoming Part 17/Part 18 updates, as well as best practices and what to be aware of when analyzing a chemistry report.

You will learn:

  • How to interpret ISO 10993-1 and what changes are coming with the next release of Part 17 and Part 18
  • Best practices for developing test plans and analyzing chemistry reports
  • Importance of complete chemical characterization and avoiding unknowns
  • Components of a complete biological evaluation