Current FDA Laws and Regulations on Radiation-Emitting Products and Radiation-Emitting Electronic Products

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Tue, Feb 16, 2016
Length
60 minutes
Product Description

Learn About the Laws and Regulations Governing Radiation-Emitting Products and Radiation-Emitting Electronic Products in the US

In the US, electronic products are subject to statutory and regulatory requirements under the applicable statute and regulations. There are various examples of electronic products: used either medical or non-medical purposes.

To bring various electronic products into the US market for use in medical purposes, it is imperative that industry should be well familiar with the statutory and regulatory requirements applicable to the electronic products for medical purposes. The electronic products used for medical purposes include, but are not limited to, microwave or ultrasound diathermy devices, x-ray (diagnostic), ultrasound imaging devices, microwave blood warmers, laser coagulators, X-ray or electron accelerators, sunlamps, ultraviolet dental curing devices, etc.

This session by our expert speaker, Dr. David Lim, Ph.D., RAC, ASQ-CQA is intended to discuss radiation-emitting electronic products used for medical purposes. It will provide great opportunities for industry professionals to get more familiar with the statutory and regulatory requirements to obtain FDA clearance or approval for electronic products. 

Dr. Lim will walk you through the statutory and regulatory requirements using examples of electronic products used for medical purposes. Learn about the laws and regulations governing radiation-emitting products and radiation-emitting electronic products in the US. This session is intended to discuss current FDA laws and regulations governing medical devices known as electronic products including radiation-emitting products (collectively called as “electronic products”).

Session Highlights:

  • Radiation Control Laws
  • Definitions
  • Regulations for Radiation-Emitting (Electronic) Products
  • Common Misconception about Laws, Regulations, and FDA Guidance
  • Regulatory Requirements for Radiation-Emitting (Electronic) Products
  • Radiation Safety
  • Common Problems for Recalls of (Radiation-Emitting) Electronic Products
  • FDA Program for Electronic Product Radiation Control
  • FDA-Cleared Radiation-Emitting Electronic Products
  • Best Practices

Who should attend?

  • Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Compliance Officers
  • Radiation Safety Officers
  • Laboratory Personnel
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

 

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert


Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.


Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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