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Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.
The following content should be included in an abbreviated 510(k) submission:
Cover sheet identifying the submission as an “Abbreviated 510(k)”
Information required under 21 CFR 807.87, including: - Description of device - Intended use and indications for use - Proposed labeling
Summary report that describes guidance, including: - How the guidance was used to demonstrate substantial equivalence - How the device complies with special controls - Device description - Manufacturer’s device design requirements - Risk management - Test methods
Voluntary Consensus Standards (if needed)
Data and information to address issues not covered by guidance documents, special controls, and/or voluntary consensus standards
