EUA – Recommended Submission Information

EMERGENCY USE AUTHORIZATION AND ENFORCEMENT

FDA RESPONSE TO COVID-19 – RECOMMENDED SUBMISSION INFORMATION

For manufacturers requesting an EUA under the current COVID-19 emergency declaration, the FDA recommends providing well-organized summary information regarding general device information, available data, safety information, effectiveness information, data considerations, risk-benefit discussion and any available, approved alternatives. Requests are to be made via email to product specific email addresses listed at the end of this document. The exact type and amount of data and safety information needed to support an EUA varies depending on the nature of the candidate product. Comprehensive effectiveness data is unlikely to be available for every EUA candidate product. FDA plans to assess the sufficiency of effectiveness data and the risk-benefit profile of each candidate product on a case-by-case basis. A risk-benefit analysis should be provided by the manufacturer containing measures taken to mitigate risk or optimize benefits, contraindications, information concerning the threats posed by the CBRN agent and anticipated response and operational considerations, as well as any limitations, uncertainty, and data gaps.

To the extent feasible, the FDA recommends providing as much data as possible. Well-organized study reports that provide a complete assessment and analysis of available safety and effectiveness data and an interpretation of the findings. If final study reports are not yet available, any available interim study reports should be provided and clearly identified as such. Source data for studies (bench, animal, and clinical) that contribute to assessing activity or effectiveness of the product should be made available. Recommended product specific information is provided in this document for COVID-19 related releases from the FDA.

General device information includes contact information, name and place of business, email address, contact information for a US agent (if any). Device information such as proprietary or brand name, model number, and marketing authorization in its country or region. If marketed under another regulatory jurisdiction, a copy of authorization letter or certification of conformity should be provided. Information whether the device has been designed, evaluated, and validated in accordance with applicable FDA recognized standards and manufactured in accordance with 21 CFR 820 or ISO 13845. Finally, a copy of labeling.

For manufacturers who are looking to enter the medical device field in order to support availability of devices, the FDA encourages contact be made via email to work collaboratively through the EUA process.

Across the board, adverse events will be reported to the FDA when actors are made aware of such an occurrence. Records associated with the EUA shall be maintained for the duration of the declared emergency. For all actors, labeling and printed material shall not represent or suggest that the product is safe or effective for the prevention of COVID-19. Labeling must be authorized and contain all relevant product information for BOTH the HCPs (may be both providers and facilities) and patients. This is in the forms of Instructions for Use and Fact Sheets. Labeling and promotions should clearly identify that products have NOT been cleared or approved by the FDA and are released under an EUA.

Note that enforcement discretion is a tool being utilized by the FDA in response to this emergency. Provided with the information for Emergency Use Authorizations, the FDA has indicated enforcement of certain requirements are being waived at this time, such as premarket requirements, registration and listing, quality systems, unique device identification, and authorized use for equipment outside of approved indicated use. These are dependent on medical product, letter of authorization, and/or enforcement policies released.