Draft Guidance: Emergency use Authorization (EUA) of Medical Products

FDA through the Draft Guidance published on Oct 6, 2009 has described the general procedure and recommendation for issuance of Emergency Use Authorization (EUA) under section 564 of FD&C act, which was amended by Project Bioshield Act of 2004. The act permits the FDA Commissioner (the Commissioner) to authorize the use of unapproved medical products or unapproved uses of approved medical products during an emergency declared under section 564 of the act. FDA recommends that a request for consideration of for an EAU include scientific evidence evaluating the product’s safety and effectiveness, including the adverse event profile for diagnosis, treatment, or prevention of the serious or life-threatening disease or condition, as well as data and other information on safety, effectiveness, risks and benefits, and (to the extent available) alternatives. FDA commissioner may establish condition on the approval of EUA that is necessary to protect the public health. Conditions authorized by section 564(e) of the act include, for example:

• Requirements for information dissemination to health care providers or authorized dispensers and product recipients
• adverse event monitoring and reporting
• data collection and analysis
• ecordkeeping and records access
• restrictions on product advertising
• distribution, and administration
• limitations on good manufacturing practices requirements

Some of the conditions specified under the statue are mandatory for the authorization of the issuance EUA. Moreover some of the conditions apply to manufacturers of a EUA product, while other conditions may apply to any person who carries out any activity for which the authorization is issued.

1. For purposes of estimating the burden of reporting, FDA has established six categories of respondents:
2. Those who file a Request for Consideration for an EUA and, in lieu of submitting the data, provide reference to a pending or approved application
3. those who file a Request for Consideration for an EUA, without reference to a pending or approved application
4. those who submit pre-EUA submissions to FDA on a candidate EUA product, which references a pending or approved application
5. those who submit pre-EUA submissions to FDA on a candidate EUA product, for which there is no reference to a pending or approved application
   5. manufacturers of an unapproved EUA product who must report to FDA regarding such activity
6. state and local public health officials who carry out an activity related to an unapproved EUA product (e.g., administering the product to recipients) and who must report to FDA regarding such activity.

For more information on the new guidance document please go to the following link:
http://edocket.access.gpo.gov/2009/E9-24048.ht

For more information on the update and to know how mdi can be assist you in the process of obtaining an emergency use authorization of your medical product please email us at info@mdiconsultants.com and reference EUA.