On January 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.
The eSTAR is an interactive PDF form that helps guide applicants through the medical device submission process.
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.
Eligibility factors for the eSTAR pilot:
- 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.
- Must be ready to submit an eSTAR for the same medical device within 6 months of pilot acceptance to both Health Canada and the FDA for:
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.