Get our free email newsletter

FDA Issues Guidance on Electronic Submissions of 510(k)s

The U.S. Food and Drug Administration (FDA) has released its final guidance on premarket notification (510(k)) submissions by electronic format.

Published in early October, the Guidance, “Electronic Submission Template for Medical Device 510(k) Submissions,” provides a detailed explanation of the structure of the agency’s current eSTAR 510(k) electronic submission template, along with a thorough description of the kind of information expected for each individual template listing (e.g., “device description,” “consensus standards,” “predicates and substantial equivalence,” “labeling,” etc.).

Where appropriate, the Guidance also lists the applicable standards and other documents that device developers should use in assessing the compliance of their device with the FDA’s requirements.

- Partner Content -

How to Perform a Radiated Emissions Measurement

Radiated emissions testing is the measurement of the electromagnetic field of the emissions that are unintentionally being generated by the equipment under test.

Guidance documents issued by the FDA and other agencies are intended solely to provide insight into the current thinking of regulators and should be viewed only as recommendations and not requirements.

Read the complete text of the FDA’s Final Guidance on electronic 510(k) submissions.  

Related Articles

Digital Sponsors

Become a Sponsor

Discover new products, review technical whitepapers, read the latest compliance news, trending engineering news, and weekly recall alerts.

Get our email updates

What's New

- From Our Sponsors -

Sign up for the In Compliance Email Newsletter

Discover new products, review technical whitepapers, read the latest compliance news, trending engineering news, and weekly recall alerts.