FDA Announces Pilot Program for Medical Device Submission with Health Canada but Spots Are Limited
Insights Amy Baker · January 12, 2023
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 Health (CDRH) or to the Center for Biologics Evaluation and Research (CBER). It is essentially an interactive smart template that streamlines electronic premarket submissions to FDA for medical devices.
FDA anticipates that eSTAR will reduce review time for premarket medical device submissions by standardizing the submission process and improving submission quality. eSTAR offers a huge benefit to manufacturers in that eSTAR submissions avoid the Refuse to Accept process encountered by many manufacturers, particularly those with less experience with FDA submissions.
While use of eSTAR was initially voluntary, manufactures will be required to use eSTAR for nearly all device submissions to FDA starting October 1, 2023. As a result, it is important for manufacturers to adjust to using eSTAR over the coming months.
Manufacturers interested in a joint submission to FDA and Health Canada should be quick to take advantage of the new eSTAR pilot by submitting a statement of interest to CBER. Only nine participants will be selected to participate in the pilot with Health Canada. Participants need to be ready to file their submission within 6 months of acceptance into the pilot program. Instructions to apply to participate in the pilot, as well as submission specifications, can be found in FDA’s eSTAR pilot announcement.
This summary is provided for informational purposes only and is not intended to constitute legal advice nor does it create an attorney-client relationship with Rimon, P.C. or its affiliates. Prior results referred to in these materials do not guarantee or suggest a similar result in other matters.
Amy Baker is a Partner in Rimon’s Orlando office. Ms. Baker focuses her practice on advising clients in the life sciences industry. Ms. Baker provides regulatory consulting services to life sciences clients, advising them at all stages of their life cycle, from formation through to clinical trials and commercialization. She advises life sciences clients on the wide range of legal issues which may impact them, including growth strategies, emerging technologies, regulatory compliance with the FDCA, as well as FDA and FTC regulations, labeling and advertising compliance, intellectual property and brand protection issues, and privacy, data breach, and cybersecurity concerns. She also works with life sciences clients to facilitate funding for early stage life science and technology companies. Ms. Baker represents life sciences companies in litigation where required. Read more here.