FDA updates the 510(k) Process  Romy Benninga 13 September 2023

FDA updates the 510(k) Process 

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FDA Releases Draft Guidance to Modernize 510(k) Clearance Process - September 6, 2023

The US Food and Drug Administration (FDA) is moving forward on its plans to modernize the 510(k) clearance process for medical devices. 

These modernization efforts are intended to enhance safety, promote innovation, and increase transparency in the selection of predicate devices. 

Three draft guidance documents have been released including: 

Selection of predicate devices 

Provides best practices to assist manufacturers in selecting a predicate device for their 510(k) submission and recommends that manufacturers describe how the best practices were used to select the predicate device in the 510(k) Summary for their new device, promoting transparency 

The use of clinical data and when it is needed to support a 510(k) application 

Provides an expansion on the policies initially described in the 510(k) Program Guidance to clarify and provide additional context and examples regarding when clinical data may or may not be needed to support a 510(k) submission 

Evidentiary expectations for implanted devices under the 510(k) process 

Provides recommendations for manufacturers on the design and execution of appropriate performance testing for 510(k) implant devices, as well as the appropriate content and labeling information to include in 510(k) submissions 

The 510(k) pathway has historically cleared medical devices based on substantial equivalence to previously approved devices that have the same intended use, with some of these predicates dating back to 1976.  

With today’s advancements in technology, materials science, digital health, and 3D printing, medical devices are innovating at an unprecedented rate. The average page count has now gone up to more than 1000 pages per submission, reflecting the growing complexity of devices and clinical data to support substantial equivalence. 

The FDA has recognized the need to update its regulatory approach to incorporate these advancements and streamline the process to ensure a fine balance between safety and efficiency is met, without holding back medical innovation. 

"We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria," FDA Commissioner Scott Gottlieb and its Director of the Center for Devices and Radiological Health Jeff Shuren said in a joint statement. 

 The FDA's Center for Devices and Radiological Health (CDRH) intends to finalize these three guidance documents to strengthen and modernize other aspects of the 510(k) Program.  

Agency officials are accepting comments on the draft guidance documents until Dec. 6 at regulations.gov. 

Want to know more? Tune in to the FDA hosted webinar on October 26, 2023, to engage with industry stakeholders.