FDA eSTAR Update: 51 Submissions, No Manufacturer Complaints
US FDA biomedical engineer Patrick Axtell gave an update on the streamlined 510(k) submission program at MedCon 2021.
You may also be interested in...
Nine device makers will soon have the chance to enroll in a voluntary eSTAR pilot program that the US agency says will make the premarket review process more efficient and consistent. The design and structure of an electronic Submission Template And Resource – or eSTAR – template is similar to templates used by FDA reviewers. An eSTAR won’t change the agency’s statutory or data requirements for sponsors to show substantial equivalence to predicate devices.
The resolution of a May 2020 warning letter to a breast implant manufacturer accounted for the only device-related close-out latter issued this month.
Intuitive Surgical is facing multiple antitrust suits that say the company took advantage of its dominant market position by demanding hospitals come to it for expensive repairs and replacements.