October 30th, 2023 – Written by Mitchell Gorthy
Summary
On October 26th, the FDA’s Center for Devices and Radiological Health (CDRH) updated draft guidances to modernize their 510(k) program. Employees from the CDRH’s Office of Product Evaluation and Quality gave brief overviews of each draft guidance. Regulatory Advisor, Megha Reddy, explained “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Submission”. Next, Deputy Director, Mary Wen, PhD, delved into “Recommendations for the Use of Clinical Data in Premarket Notification 510(k) Submissions”. To conclude, De Novo program Lead, Peter Yang, PhD, RAC, expanded on “Evidentiary Expectations for 510(k) Implant Devices”.
510(k) Modernization Program
Since 2009, CDRH has issued over 100 final cross-cutting and device-specific guidances to clarify 510(k) review expectations. Furthermore, CDRH initiated dockets to gather input on FDA’s proposal to list FDA-cleared devices on its website, demonstrating substantial equivalence to older predicates. Alongside this, they solicited feedback on actions for promoting safer, more effective device development and marketing.
Notably, CDRH also raised the question of whether the FDA should consider new authority, which could involve rendering certain older devices ineligible as 510(k) predicates. This progressive approach by the FDA aimed to modernize the 510(k) program, spurring innovation and enhancing patient safety. As a result, the feedback led to the development of three draft guidances, focused on enhancing predictability, consistency, and transparency within the 510(k) program.
Draft Guidance: “Best Practices for Selecting Predicate Device to Support a 510(k) Submission”
This draft guidance promotes safer and more effective 510(k) medical devices. It emphasizes assessing predicate device characteristics over their age. Best practices are crucial in this regard. To select a predicate for your 510(k) submission, consider legally marketed devices and identify a “valid predicate”.
When choosing predicated devices, prioritize those cleared via established methods, meeting or exceeding safety and performance standards, without unresolved safety or design issues and not subject to design-related recalls. This approach fosters better device evolution and quality within your 510(k) device submission.
Draft Guidance: “Recommendations for the Use of Clinical Data in 510(k) Submissions”
This draft guidance clarifies the need for clinical data to demonstrate substantial equivalency (SE) in 510(k) submissions, offering examples for clarity. It aims to enhance predictability and transparency in these situations. Clinical data is commonly used to asses a new device’s safety and effectiveness compared to a predicate device, typically after demonstrating identical intended use.
However, there are cases where clinical data is essential for SE determination. These include differences in indications for use, technological characteristics, inability to establish SE through non-clinical testing, or heightened risk associated with the predicate device. The guidance provides context and examples for these scenarios to streamline the 510(k) process.
Draft Guidance: “Evidentiary Expectations for 510(k) Implant Devices”
This draft guidance offers general recommendations for 510(k)-required implant devices, encompassing aspects like human factors, patient experience data, and labeling. The term “implant” herein pertains to devices meant for continuous implantation for 30 days or more, though many review considerations apply to shorter durations as well.
Key considerations include indications for use, implantation duration, and patient-physician experience. Non-clinical performance testing, such as biocompatibility, degradation, sterility, software security, and more, also hold relevance across 510(k) implants. Data requirements vary based on device type and differences from predicate devices.
How can Enerxen help?
Enerxen is a trusted partner for the FDA’s 510(k) program, providing invaluable support to companies navigating any 510(k) submission. We understand the unique challenges and nuances of the regulatory landscape and are committed to helping you achieve compliance efficiently and effectively.
Contact us today to get started towards the path of regulatory success with a complimentary consultation with one of our seasoned experts. We will work closely with you to tailor a regulatory strategy. Additionally, find a more in-depth overview to our service what we do here.
Related Links
Best Practices for Selecting Predicate Device to Support a 510(k) Submission
Recommendations for the Use of Clinical Data in 510(k) Submissions