The 510(k)-clearance program, also known as Pre-Market Notification (PMN), is US FDA’s device review pathway to ensure safe and effective entry of medical devices into the US territory. US FDA requires manufacturers of the majority of Class II devices and a few Class I and III devices to obtain 510(k)-clearance.

Annually, more than 500 devices are cleared through the 510(k) program. Preparing for 510(k) can be challenging for the manufacturers as FDA has set specific Regulatory requirements on how to organize the submissions. The applicants must ensure to include all relevant data, test reports, and other essential documentation. Additionally, they must meet the FDA’s eCopy (electronic document) submission requirements to clear the very first acceptance review step.

With the technological advancement and aggressive competition in place, the device manufacturers enduring improvised device features, leading to challenges in determining appropriate predicate and substantial equivalence. Manufacturers of digital medical devices must understand specific Regulatory requirements set up by the USFDA while applying for 510(k) clearance.  

To streamline the electronic submission of the 510(k) applications, the USFDA has launched a pilot program, eSTAR (electronic Submission Template and Resource), to ease the submission and review process. The program also enables manufacturers to submit a quality 510(k) application.

As a manufacturer, identifying the right predicate for your devices and establishing the substantial equivalence for successful 510(k) clearance is crucial. Do you know:

  • How do we identify and narrow down predicate devices for 510(k) clearance?
  • The effective strategies for establishing a substantial equivalence with the predicate device?
  • The key considerations for digital health product submissions?
  • When to opt for pre-submission and Q-submission meetings with US FDA?
  • What could cause major deficiencies during the review, and how to avoid them?
  • The do and don’ts for the eSTAR program?

To explore and understand the USFDA’s most prominent device clearance pathway, Freyr brings you an exclusive webinar on Foundation Masterclass: 510(k) Clearance Pathway,” scheduled on September 07, 2022. In this webinar, our in-house Regulatory expert, Shilpa Gampa, Head-Medical Device Regulatory Affairs- US, Canada, and EU, will elaborate on how to identify the predicate along with strategies to establish substantial equivalence, when to opt for pre-sub and Q-sub meetings, and best practices for successful 510(k) clearance. Register now for clear-cut insights.



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