The 5 Most Important Regulatory Events of 2023
And What They Mean for Your FDA Submission
With each passing year a handful of significant events occur within the FDA regulatory landscape.
Some events yield major, long term implications, while others, though much subtler, may lead to crucial shifts impacting day-to-day business operations. These occurrences, be they new guidances, proposed rule alterations, or procedural modifications, all carry implications for both immediate workflows and long-term strategic planning. Let's delve into five key events of 2023 and their ramifications on your FDA submission process.
1. April 2023 - FDA's Emphasis on Artificial Intelligence/Machine Learning
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With the release of crucial guidances like Predetermined Change Control Plans (PCCP) and a notable increase in the clearance of AI devices, it is evident that the FDA is allocating resources to address concerns surrounding these technologies. The message for submission stakeholders is clear: meticulous attention to detail is paramount. Engage with the FDA early, comprehend their expectations. Have a detailed regulatory plan and testing plan in place ahead of time so it’s easier and less costly as the project progresses. Simplicity and early communication are key amidst the heightened scrutiny on AI devices.
2. May/June 2023 - Modernizing Clinical Trials
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In support of these efforts, another draft guidance for Decentralized Clinical Trials was also released. What does all this mean for your submission? It seems to have a two-fold effect. One, patient recruitment and data acquisition may become much more streamlined for your clinical trial. Moreover, the updated GCP recommendations seem to promote the adoption of innovative digital health technologies (DHTs) that are tailored for specific purposes. For instance, and in true reciprocity, the incorporation of wearable sensors in DHTs has the potential to streamline data collection and aid in the patient recruitment we just talked about. Submitters should adapt to these changes by embracing digital tools and ensuring alignment with evolving clinical trial practices. And if you are a digital health manufacturer, this can only be good news for you.
3. September 2023 - Lab Developed Tests (LDT) Proposed Rule
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The complexity and prevalence of such tests necessitate regulatory oversight for patient safety and effectiveness. Manufacturers of LDTs are urged to initiate product evaluations now, as a 3-4 year timeline looms for completing IVD marketing applications. The implications of this rule change are substantial, emphasizing the urgency for early assessment and strategic planning. Find out more here.
4. September 2023 - FDA's 510(k) Process Overhaul with eStar Format and Guidances
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In an online era, it’s a relief to see the eCopy a thing of the past, but with this change comes the learning curves. Find out what these new guidances mean for your submission. In terms of your eStar submission, submitters must adapt by familiarizing themselves with the new eStar format prior to drafting your submission. This is not a like-for-like conversion from the old eCopy outline. Failure to do so risks wasting valuable time and resources. Submitters must adapt by familiarizing themselves with the new eStar format. Thorough preparation and a proactive approach are essential in navigating this transformed submission landscape.
5. November 2023 - FDA Extends COVID-era Policy on Device Modifications
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The enforcement policy, initially implemented due to pandemic-induced shortages, remains in effect until further notice while FDA continues to monitor the situation. PMA and HDE manufacturers, who would typically file supplements for device modifications affecting safety and effectiveness, are granted latitude until the FDA signals a change back to the previous way. As FDA has stated they still are able “to observe supply chain challenges and shortages of medical devices remain widespread”. This extension offers a strategic advantage, allowing manufacturers to adapt to ongoing supply chain challenges without immediate regulatory obligations.
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Keeping an eye ahead to the new year, while technically released in 2023, its implications will no doubt be extended into 2024 and beyond. The FDA release of its new proposed rule to update many antimicrobial solid wound dressings, wound dressings formulated as a gel, creams, or ointment, and liquid wound washes, many of which reside as Class I or Class II devices, into Class III devices. With concern for antimicrobial resistance increasing, submitters may need to gear up for more strict regulatory controls and testing requirements for these products. More to come in 2024.
Conclusion
In conclusion, staying attuned to these regulatory shifts is essential for navigating the intricate submission landscape. As the regulatory terrain evolves, the same cornerstones remain year after year for successful submissions, early engagement, strategic planning, and adaptability.
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