Manufacturers are not the only ones facing challenges due to the updates to ISO 10993 and other recent regulatory changes. The evolving standards are also affecting testing labs. Previous industry projected timelines and costs are becoming less feasible with today’s regulatory requirements and capacity constraints. These circumstances have left manufacturers asking important questions, such as why timelines have increased and why testing partners now advise companies to provide additional information or retest.
These questions are all valid, and it is time for testing labs to pull back the curtain to address them. To put it simply – the answers boil down to changes in expectations, process and availability.
Most lab testing partners and manufacturers generally knew what to expect from the ISO 10993-18:2020 updates, but it was a waiting game to see how the U.S. Food and Drug Administration (FDA) would interpret them. Part 18 was published in January, and the FDA has been communicating additional expectations through presentations at various venues such as conferences and scientific forums. However, they have not formally documented expectations in guidance as of yet, and shifts in expectations continue as new information is submitted. The dust has yet to settle with the latest update to the standard and FDA expectations.
Manufacturers that have performed testing recently (as recent as late 2019) are seeing gaps in their testing compared to what the FDA is requesting. The FDA website states it will accept testing from the previous standard until July 10, 2022, but reality may prove otherwise. There may be additional information that can be provided to bring your testing up to FDA standards, but in many scenarios, it may be best to start testing from scratch.
In 2020, the FDA increased the expectations of chemical characterization. They are now probing deeper and asking for more technical evidence than ever before. For a submission to be successful, laboratories and manufacturers will need to justify everything – why they chose particular solvents, why they conducted the extraction in a specific way, why they selected a particular method of preparation, and what documentation supports each decision. Ensuring you have the justification to back up your testing takes time and resources. It’s essential to build this into your timeline and budget.
With increased regulatory expectations comes more responsibility for lab partners. Regulatory bodies are demanding that labs identify all compounds found above the analytical evaluation threshold (AET). If they cannot identify the compounds or provide details to inform the chemical structure, it could negatively impact your timelines, as retesting may be your only option.
No matter the stage of the medical device, pre-clinical to post-submission, manufacturers will need to plan accordingly for shifting expectations. You may receive more submission questions from the FDA than in the past and will need to change your process and timeline accordingly when entering the regulatory review process. Prepare to get additional information requests and allocate time to answer them. Depending on how long ago you performed the testing, responding to an additional information request may mean further testing and require a substantial amount of time.
If you’re still in the testing stage, be sure you’re partnering with a testing lab well-versed in what these process changes mean to your budget and timelines. Quality testing procedures may cost more initially but will save time on unexpected delays or additional testing down the road. It’s crucial to give the lab time to reflect and provide thoughtful, scientifically-sound justifications and recommendations.
Labs are filling up, and fast, due to the shifting regulatory expectations and delays raised in 2020. Additionally, the medical device industry is transitioning to the E.U. Medical Device Regulation (MDR) requirements. The increased effort to achieve this is putting a significant amount of stress on the labor market. More rigorous testing means less capacity of analysts, laboratory techs and data analysts. Expediting your testing is rarely an option in the current climate. The longer you wait to communicate your submission strategy and timeline with testing labs, the longer it will take to secure a spot in line.
What You Can Do
Testing partners are sympathetic to what these changes mean to manufacturers, and they are doing everything they can to make the testing and submission process as streamline as possible. The best way to establish a productive partnership is to plan accordingly. Trust your well-vetted laboratory’s experience, and build time for additional information requests into your timeline. Try to avoid rushing to the finish line. Design testing plans to produce data with longevity.
Achieving the level of quality necessary to earn regulatory approval may mean larger budgets and extended timelines, but in the long-term, it will save time and money. By understanding the challenges that can compound into timeline delays – expectation, process and availability changes – and taking them into account when you approach your lab testing partner, you can work together to achieve successful studies.
Established in December 2000, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 4,100 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated”.
For more information, please visit: http://medicaldevice.wuxiapptec.com/
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