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AR. Page 3 of 3 pages. FORM FDA 2784 (10/80). 73. Y--YES. N--NO. PBL Sizing (Continued). 14. 69. 76. 65. Indicated SID. Actual Versus Indicated Field Size ...
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What is form fda 2784 1080?
Form FDA 2784 1080 is a specific form used by the Food and Drug Administration (FDA) to collect information on adverse events and product complaints related to FDA-regulated products.
Who is required to file form fda 2784 1080?
Manufacturers, distributors, importers, and other responsible parties of FDA-regulated products are required to file form FDA 2784 1080 if they become aware of any adverse events or product complaints related to their products.
How to fill out form fda 2784 1080?
Form FDA 2784 1080 can be filled out online through the FDA's Electronic Submissions Gateway (ESG) or by submitting a paper form via mail or fax. The form requires information such as the product name, date of the event, description of the event, contact information, and any supporting documentation.
What is the purpose of form fda 2784 1080?
The purpose of form FDA 2784 1080 is to allow the FDA to collect data on adverse events and product complaints in order to monitor the safety and effectiveness of FDA-regulated products and take appropriate actions to protect public health.
What information must be reported on form fda 2784 1080?
Form FDA 2784 1080 requires the reporting of information such as the product name, date of the event, description of the adverse event or product complaint, contact information of the person reporting, and any available supporting documentation.
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