FDA eSTAR Update: 51 Submissions, No Manufacturer Complaints
Executive Summary
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...
Lucky STAR: FDA’s eSTAR Pilot Aims To Make 510(k) Process Smoother
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.
News We're Watching – 27 January
This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel.
Product Liability Missteps Top List Of Worst Legal Verdicts Of 2022
A recent webinar ranking last year’s best and worst legal verdicts said that product liability cases involving pelvic mesh and artificial lenses were the very worst.