Moving the Needle and Modernizing the 510(k) Process

FDA recently announced its latest efforts to strengthen and modernize the 510(k) process and to advance the safety and effectiveness of medical devices. As part of its ongoing commitment to optimize the clarity, predictability and consistency of the 510(k) Program, the Agency announced the release of three new draft guidance documents in alignment with the FDA’s continued focus of meeting patients needs, supporting decision-making based on sound science and promoting public health. 

In its announcement, FDA importantly highlights the Safety and Performance Based Pathway, an alternative to the Traditional 510(k) program, which the Agency launched in 2019. This new and efficient pathway allows manufacturers of certain, well understood device types, to demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device. This pathway may also provide for manufacturers to demonstrate that their device meets or exceeds modern performance criteria to support 510(k) clearance, as well as promote the development of safer, more effective devices, by demonstrating their product’s superior performance to existing devices more readily. The Agency notes that there are now ten-device specific final guidances permitting the use of this pathway for clearance of the following device types: Spinal Plating Systems, Orthopedic Non-Spinal Metallic Bone Screws and Washers, Magnetic Resonance Receive-Only Coils, Cutaneous Electrodes for Recording Purposes, Conventional Foley Catheters, Fracture Fixation Plates, Surgical Sutures, Denture Base Resin, Facet Screw Systems, and Soft (Hydrophilic) Daily Wear Contact Lenses.

Additionally, FDA announced that the electronic Submission Template and Resource (eSTAR) program becomes mandatory, effective October 1, 2023. This means that all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR.

The three new draft guidances importantly address specific components of the 510(k) program including the Center for Devices and Radiological Health (CDRH) recommendations for selecting a predicate device, instances when clinical data may be necessary in a 510(k) submission, and evidentiary expectations for 510(k) submissions for implanted devices. These draft guidances demonstrate new measures the FDA is taking to further modernize the 510(k) program and to help improve the safety and effectiveness of devices in the 510(k) program over time. As FDA’s 510(k) program remains the device premarket pathway that is most frequently used, the Agency’s efforts towards clarity on requirements and submission predictability is key for device sponsors.

Whether you are a Company manufacturing, distributing, developing or otherwise involved with submission of a 510(k) for a medical device including a cosmetic device, we strongly recommend familiarizing yourself with the new guidance documents and mandatory e-submission criteria. For questions on the new draft guidances, FDA’s 510(k) program, or other regulatory compliance or enforcement, please contact us at info@garg-law.com.