On 28-September, 2021 USFDA released draft guidance to assist sponsors in using an electronic template for submitting a premarket notification 510(k).
FDA is issuing this draft guidance document to introduce submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health (CDRH) and Center for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.
The guide 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.
The rest of the guide covers the different sets of documents that manufacturers and importers need to provide to register their medical devices. Both sets of companies need to provide a certificate of compliance with ISO 13485, which covers quality management systems, “accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum.”
This draft guidance describes the technical standards associated with the preparation of the electronic submission template for 510(k)s that, when the guidance is finalized, will enable submission of the 510(k) electronic submission solely in electronic format.
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