The journey of bringing a medical device to market can often be sidetracked by unforeseen challenges, which underscores the importance of meticulous planning and adaptability. Our recent experience with a FDA PMA audit sheds some light on the complexities in navigating the FDA submission process.
Medical device development is a lengthy process, with estimates for time to market ranging from 3 to 20 years depending on device complexity. (1, 2) FDA approval can also vary significantly, from 1-2 years for Class I devices to over 12 years for Class III devices. (3)
Recently we were involved in a PMA audit with a client who was preparing to resume manufacturing. After 10 years on the PMA path, we needed to keep a tight timeline that prioritized funding and viability.
To this end, our team leveraged previously completed validations from the first iteration of the project while working towards revalidation as the manufacturing schedule allowed. As these types of complex projects go, the FDA audit occurred before all of the revalidations could be completed.
Despite initial progress, the FDA abruptly halted the inspection after two days, citing the need for all revalidation, documentation, and design transfer activities to be fully completed before resuming the audit. No allowance would be given to evaluate activities as they were completed to reduce time to market.
Key Learnings:
Completed Validation is Crucial: The FDA will not complete inspection until ALL validation and revalidation activities are fully complete.
Manufacturing Records Matter: One big takeaway was the requirement for a complete manufacturing record at the production level. Without this, the audit hit a roadblock. The FDA would not complete the inspection unless there was at least one full manufacturing record available at the production level.
Design Transfer Complete: All applicable design transfer activities that were product manufacturing related must be completed before the audit. There is no allowance for activities yet to be completed. Speed to market is crucial, particularly for many new companies with timelines that are based on limited funding. Therefore, readiness dates provided to the FDA are typically optimistic estimates, assuming all remaining activities proceed without issues or contingencies.
The rigorous FDA audit provided invaluable experience, highlighting critical aspects of regulatory compliance and quality management. We are looking forward to applying these learnings to further enhance our processes and deliver safe, effective medical devices to those who need them most!
If you’d like guidance on your PMA project, contact us at quality@cannonqg.com.
References:
- 10.1136/neurintsurg-2012-010400
- 10.1001/jamanetworkopen.2022.31609
- 10.1016/j.jhsa.2021.07.011
