Medical Devices and Radiation-Emitting Products: FDA Requirements
Overview:
As an experienced FDA medical device investigator, at one time or another many firms have failed to incorporate the requirements of 21 CFR 1002 and 21 CFR 1040 when designing and planning to file premarket clearance documents with FDA.
Why should you Attend: Since 2004 until 2014, one of my responsibilities as an FDA investigator was to oversee the Electro-Optics Program for Southeast Region, As the Electro-Optics Specialist I inspected many medical device firms that incorporated a small laser as an aiming or positioning mechanism or applying a UV lamp to sterilize the contact surface of a medical apparatus.
There are specific requirements under FDA regulations governing these devices that many device manufacturers have failed to take into consideration. Filing the 510(k) for premarket clearance and performing biocompatibility testing, process validations, etc. come naturally as part of the natural design approval process; however the filing and reports required for radiation emitting devices are many times forgotten.
This webinar will assist the viewer with the requirements under FDA regulations to ensure you medical device is compliant with all FDA regulations and reporting.
Sufficient time will be provided for Q&A.
Areas Covered in the Session:
- What is a Radiation Emitting Device
- What is eSubmitter
- How to Annual Reports
- When to report to FDA
- How to report to FDA
- What can happen when you fail to report
Who Will Benefit:
- All Medical Device manufacturers who have laser, x-ray or UV components as part of their medical device design regardless of Class of Medical Device