FDA begins pilot for new 510(k) submission template for device manufacturers

MPN editor Laura Hughes explains the FDA's new pilot program, and how to get involved.

What does this pilot involve?

This voluntary pilot assessment of the template will include up to nine participants which the FDA claims will provide a representation of the medical device industry. Each participant must submit at least one 510(k) application using the electronic Submission Template and Resource (eSTAR) within three months.

Additionally, the FDA has implemented functions such as additional support for mobile devices, the ability to share part-completed filings via email, and also the option to post comments even after the file is converted to a static PDF.

Will this new system be difficult to implement?

The FDA claims that the structure and content of the PDF filing template are similar to resources already used internally. This allows staff to evaluate submissions more efficiently.

Is it too late to get involved?

The FDA is currently accepting requests to join this program. However, you need to be willing to submit details regarding the size of your company’s operations e.g. Employee numbers, revenue information, and details about devices the organization plans to file. It is also important to note that combination products cannot be submitted as part of the pilot. After taking part, the FDA will be asking for feedback on the process.