On February 27, 2020, the U.S. Food and Drug Administration (FDA) announced the launch of its new pilot program for 510(k) submission templates. The updated template, referred to as the eSTAR (electronic Submission Template and Resource), is intended to improve efficiency by offering consistency throughout the submitter and reviewer templates.
Created in an interactive PDF form, the 510(k) template includes:
- Automation (required forms, automatic filling of fields, et. al.)
- Immediate access to FDA guidance and databases
- Specific guidance for each section
- Automated verification of contents
Use of the template is currently limited to no more than nine (9) manufacturers, and applicants must meet the following criteria:
- Plan to submit a 510(k) within three (3) months of acceptance
- Have a device that is body contacting and include software (but not a combination device)
- Willing to provide feedback on the template and process to FDA
Pilot participants gain the benefit of a structured submission process and avoidance of the Refuse to Accept review.
Although this template will assure greater consistency and efficiency throughout the 510(k) process, success in gaining clearance will still rely on high quality data within 510(k) applications. More information on eSTAR and the application process may be found here.
How can NAMSA Help?
Navigating the U.S. FDA regulatory landscape can be overwhelming for any medical device manufacturer – not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving reimbursement requirements, market success and accelerated timelines.
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the FDA. In fact, our internal teams of medical device development experts communicate with the FDA nearly every day. From Pre-Submission meetings – to Pre-IDE preparation – and FDA inspection preparation, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines..
If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: https://www.namsa.com/contact-us.
Dennis H. Crane
Dennis Crane serves as NAMSA's North American Regional Director of Consulting Services.