Our Regulatory Blog

Never miss a thing! The latest regulatory news and updates are always on our feed.

FDA eSTAR Pilot Program FDA

FDA eSTAR Pilot Program

The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the eSTAR Pilot Program, which is a part of the 510(k) Program Pilots together with the 510(k) Review...

Read More

FDA on 510(k) Acceptability Criteria FDA

FDA on 510(k) Acceptability Criteria

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the specific criteria applied by the Agency when determining whether a 510(k) Premarket Notification...

Read More

FDA Guidance on Types of Communication FDA

FDA Guidance on Types of Communication

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the types of communication during the review of medical device submissions. The document is intended to...

Read More