Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 22, 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Device Approval Government Regulation United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- 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. 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.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (13 pages))
- NLM Unique ID:
- 9918486675406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918486675406676