FDA 510k电子文件提交指南
The Food and Drug Administration (FDA or Agency) is issuing this guidance document to introduce submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support 510(k) electronic submissions to FDA. This guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.1 This guidance facilitates the implementation of the FDA’s mandate under section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by section 207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115- 522 ) to provide further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.
