Report Requirements for Radiation Emitting Products; CeSub & ESG

Overview:

By attending this webinar the attendee will become familiar with how the process works and what need to be done for access to the FDA ESG.

As anyone in the X-ray Business is aware, the FDA has report requirements for all radiation emitting products. This presentation will provide the attendee with an overview of the report requirements defined by the FDA regulation in 21 CFR Part 1002 – Records and Reports. This will include the various types of reports such as Manufacturer Reports, Assembler Reports, Initial Reports, Supplemental Reports and Annual Reports that the FDA requires for Radiation Emitting Products. This will provide the attendee with an overview of the types of reports shown in Table 1 of 21 CFR 1002.1 – Applicability. This presentation will concentrate on those reports necessary for Diagnostic X-ray and its associated equipment. In an effort to keep ourselves from maintaining mountains of paper to keep on hand and for submittal to the FDA, a variety of these reports may now be compiled electronically using the FDA’s CeSub (Electronics Submission Software) and the electronic submission process via the FDA’s Electronic Submission Gateway (ESG). These recent additions have made the process of report submission much easier and faster with an almost instantaneous accession number received back from the CDRH (Center for Devices and Radiological Health) branch of the FDA. This webinar will provide the attendee with a review of the use of the CESub software and an overview as to how the FDA’s ESG works. The process for acquiring access to the Electronic Submittal gateway can be long and tedious if not done properly.

Areas Covered in the Session:

• Review of Required Reports for FDA 21 CFR Part 1002 - Records & Reports
  
• Concentration on Initial and Annual Reports on X-Ray Equipment
  
• Initial Report Content Requirements
• What Needs to be in the DHF
• FDA Guidance Documents
• Annual Report Content Requirements
• FDA Guidance Documents
• When Reports are required to be Filed
• FDA Electronic Report (CeSub Software)
• FDA Electronic Submission Gateway

Who Will Benefit:

• Design Engineers
• Quality Assurance Personnel
• Program Managers
• Manufacturing Engineers
• Regulatory Personnel
• Engineering Managers