Application of the “Solely Engaged” Exemptions in Parts 117 and 507; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Application of the "Solely Engaged" Exemptions in Parts 117 and 507; Draft Guidance for Industry." The draft guidance, when finalized, will help establishments and facilities subject to certain FDA regulations determine whether they are "solely engaged" in certain activities. Establishments and facilities "solely engaged" in certain activities are exempt from some or all requirements of the regulations.