Supply chain difficulties haven’t gone away, and the FDA is acknowledging it. The administration has decided to extend a policy that waives the requirement for medical device manufacturers to receive prior authorization before making alterations to certain products or manufacturing processes if the changes are due to supply chain issues.
In May 2020, the FDA released the guidance to allow medical manufacturers to adapt to the production challenges of the pandemic. The FDA had already extended the policy once, which would have ended on November 7, 2023, but instead chose to extend the policy indefinitely for the time being.
What It Means
It’s important to note that the guidance makes it clear that the alterations to products or the manufacturing process can only be “limited modifications” if you want to avoid receiving prior authorization for devices authorized through the PMA and HDE process.
An example of a “limited modification” to the design and manufacturing process could be making a change because specific components are unavailable due to supply shortages, according to MedTechDive.
Extensive changes will still require prior authorization, particularly for those that compromise the safety or performance of the device. Even if a modification meets the criteria for bypassing prior authorization, it will still need to be outlined in your periodic reports to the FDA.
Planning For the Future
While it is helpful that the FDA is recognizing supply chain challenges and allowing manufacturers to bypass prior authorization for certain changes, we can’t expect this extension to last forever. Even if it does remain in place for some time, the companies that master receiving authorization from the FDA will perform better overall than their competitors. Forward thinking companies can simplify the authorization process by having an ERP that tracks everything for you and makes it easy to document your procedures. With an ERP like Infor CloudSuite Industrial (CSI), you also have real-time data to see exactly what your production line is doing. For Infor CloudSuite consulting, talk to the experts at Datix. We support you every step of the way with your software so you can adapt to whatever regulations the FDA throws at you.
This extension helps medical device manufacturers adapt to the challenging circumstances of global affairs. If you are unsure if your company can react to another disaster, Datix can help. We use software to build resiliency and efficiency into manufacturers’ business processes.
Learn more about Effectively Managing Your Multi-Level Supply Chain
For medical manufacturers, Datix is the software consultant of choice. We recognize that each manufacturer is unique and requires a tailored solution to meet their business goals. Our team will partner with you every step of the way to bring your organization to the next level.