FDA - Electrical submission Guidance

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eSTAR
electronic Submission Template And Resource

In order to export medical devices to the U.S., devices and facilities shall be registered through propriate procedures for the FDA . Most FDA submissions are made through eCopy, and the FDA has published eSubmission guidelines through eSTAR to reduce unnecessary lead times arising from post submission.

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In the case of documents submitted through eSTAR, there is no RTA review. It means that it is possible to shorten the lead time used for the existing RTA review.

- The documents submitted through eSTAR have no RTA review, so the review will begin according to 21CFR807 Subpart E.

- eSTAR is highly automated, includes integrated databases (e.g., FDA product codes, FDA-recognized voluntary consensus standards), and includes targeted questions designed to collect specific data and information from the submitter.

- If the eSTAR is not complete when submitted, it will be placed and remain on hold until a complete replacement eSTAR is submitted to FDA. If a replacement eSTAR is not received within 180 days of the date of technical screening deficiency notification, FDA will consider the 510(k) to be withdrawn and the submission will be closed in the system.

 

Contents

The eSTAR template consists of the following configuration.

 

- Submission Type

- Cover Letter

- Submitter information

- Pre-Submission correspondence & Previous Regulatory interaction

- Consensus standards

- Device description

- Proposed Indications for Use

- Classification

- Predicates and Substantial equivalence

- Design/Special Controls, Risks to Health, and Mitigation Measures

- Labeling

- Reprocessing

- Sterility

- Shelf life

- Biocompatibility

- Software/Firmware

- Cybersecurity/Interoperability

- Electromagnetic Compatibility (EMC), Electrical, Mechanical, Wireless and Thermal Safety

- Performance Testing (Bench/Animal/Clinical)

- References

- Administrative documentation

 

* For more information, please refer to the FDA Guidance below.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-510k-submissions

 

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