FDA Announces Pilot Program for Medical Device Submission with Health Canada but Spots Are Limited
On January 10, 2023 the FDA announced that it has partnered with Health Canada to launch a joint eSTAR pilot. The pilot will allow medical device manufacturers to submit a premarket notice submission to FDA and Health Canada simultaneously. eSTAR initially debuted in 2020 for medical device submissions to FDA’s Center for Devices and Radiological…