On January 10, 2023, the U.S. Food and Drug Administration (FDA) and Health Canada announced a new joint pilot program. This program will conduct tests on the use of FDA’s eSTAR to make a single medical device submission to both FDA and Health Canada.
What is eSTAR?
eSTAR is a pdf-based form for medical device manufacturers submitting 510(k)s and De Novos to FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). eSTAR is interactive, provides guided instruction for each submission section (integrating guidances, databases, etc.), is automatically verified and the structure is based on CDRH internal templates for ease of FDA review. It is free and currently available for voluntary use by medical device applicants.
Manufacturers must be ready for medical device submission to FDA and Health Canada within six (6) months of acceptance into the pilot. For Health Canada, the submission should be for a new or significant change amendment for a Class III or IV device. For FDA, the submission should be a 510(k), De Novo or pre-market approval (PMA) original, 180-day, real-time or panel track supplement. The submission must be made through eSTAR and in English.
Nine (9) participants will be chosen for the pilot. To request participation, an applicant should send an email to firstname.lastname@example.org and eSubPilot@fda.hhs.gov with the subject line “Request for Participation in eSTAR Pilot”. The agencies will respond to the request within three (3) days. The body of the email should include:
- A statement asking to participate
- Applicant name
- Contact name and title
- Device trade name(s)
- The FDA primary product code, Global Medical Device Nomenclature (GMDN) and Preferred Name Code (PNC) of device
- A statement that the medical device will be submitted within six (6) months of acceptance in the eSTAR pilot to both Health Canada (specify if new or significant change amendment for a Class III or IV) and the FDA (specify if 510(k), De Novo or PMA submission [specify further if original, 180-day, real-time or a panel track supplement]).
The agencies will provide an information packet on preparing submission and the process. The agencies recommend that the eSTAR be under 1 GB in size and any media files need to be compressed (but viewable). To keep file size down, the agencies request attachments of similar content to be combined in a pdf and for bookmarks or a table of contents to be included.
Fees and review timelines are the same as a standard submission. If the agencies request additional information in the review of the submission, the response will be in eSTAR for FDA but not for Health Canada. Health Canada will provide information on how they want the response submitted.
For further details, you can visit the FDA website at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/health-canada-and-fda-estar-pilot and the Health Canada website at: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/notice-industry-health-canada-fda-estar-pilot/estar-pilot-program.html.
Health Canada is also running a separate eSTAR pilot for Health Canada-only submissions, and will select 10 applicants. Many of the requirements mirror the combined pilot. To learn more about this separate pilot program, you can visit the same website linked above for Health Canada.
How can NAMSA Help?
Navigating the FDA regulatory landscape can be overwhelming for any medical device manufacturer—not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving regulatory requirements, market success and accelerated timelines.
NAMSA is here to help. We are the industry leader in driving successful regulatory outcomes for medical device manufacturers. NAMSA’s regulatory team can assist in developing or reviewing eSTAR submissions. NAMSA has a strong relationship with the FDA and can provide communication and logistic resources.
Marcella Martin, MBA, RAC is a Senior Regulatory Consultant at NAMSA with over ten years’ experience working in regulatory affairs in the medical device and pharmaceutical industries. She has authored and managed a variety of submissions to FDA, Health Canada and notified bodies. These have included pre-submission, IDE, IND, technical file, master file, device license application, ANDA, Annual Report and vigilance reporting. She has completed regulatory assessments and regulatory strategies for products in development and for proposed changes to products already on the market. Marcella holds a Masters of Business Administration (MBA) degree from Colorado State University, Fort Collins and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).