Examples of Condition of Authorization in a sentence
A Condition of Authorization (Section IV.S) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators are adequate for reuse following 4 decontamination cycles.
Incorporation of a Condition of Authorization that requires healthcare facilities to ensure that HCP receive the same model of decontaminated compatible N95 respirator for which they have been fit tested.
A Condition of Authorization (Section 7 HCP refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air.
Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and 2 The revisions to the July 13, 2021, letter and authorized labeling include: (1) updates to the intended use to add anterior nasal (AN) swab specimens as an authorized specimen type; (2) updates to the performance data to include results of clinical testing AN swab specimens; (3) removal of Condition of Authorization Q.
The EUA Condition of Authorization IV.L for this device expressly states that changes to the Scope of Authorization (Section II) of the EUA may be made in consultation with, and require concurrence of, FDA.
This revision also establishes one additional Condition of Authorization, and eliminates one Condition of Authorization, on EUAs that are within the scope of this revision (Section I).
Results from specimens collected from individuals without symptoms or other reasons to suspect COVID-19 may be provided either in your notification to FDA or post-authorization as set forth in Condition of Authorization Y of this letter.
Any modifications to your authorized product, including the authorized labeling, must be made in accordance with Condition of Authorization G of this letter.
November 1, 20214 and January 27, 2022.5 In addition, based on your requests, FDA granted an update to the authorized labeling on August 3, 2022.6 Further, FDA revised the authorized uses and established one additional Condition of Authorization requiring updates to product labeling regarding repeat, or serial, testing, for all currently authorized SARS-CoV-2 antigen tests on November 1, 2022.7 On July 29, 2022, FDA received a request from you to amend your EUA.
The available evidence indicates that mortality is elevated for HGB levels below 10 to 11, but the evidence is ambiguous about the precise value in that range at which mortality becomes elevated.