Article | November 6, 2024

FDA eSTAR Template: Navigating FDA's 510(k) Submission Requirements

Source: ProPharma
GettyImages-1654862265 FDA, regulations

The FDA’s eSTAR template is a transformative step for medical device submissions, now required for 510(k) filings as of October 2023. By guiding Sponsors through FDA-required content with built-in prompts, eSTAR aims to reduce Refuse to Accept (RTA) rejections by ensuring essential information is included upfront. However, adapting to eSTAR’s single-user format, managing multiple attachments, and tracking document changes can be challenging for Sponsors used to the eCopy format.

As CDRH continues updating eSTAR (currently on Version 5.2), keeping up with changes is critical; filing with an outdated version can lead to delays if additional information is requested. To aid in these transitions, ProPharma offers extensive expertise in eSTAR navigation and regulatory compliance. ProPharma’s regulatory consultants monitor all template revisions, preventing technical setbacks and allowing regulatory teams to focus on content accuracy.

Beyond eSTAR expertise, ProPharma’s services encompass the full medical device lifecycle, from regulatory strategy and quality management to submission support and risk management. Their knowledge of FDA’s processes, combined with global regulatory experience, ensures that clients receive optimal support from concept to market. With ProPharma’s support, Sponsors can confidently navigate eSTAR requirements, reducing the risk of delays and successfully advancing their products through FDA’s approval process.

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