transitive verb
:to make changes: do something in a new way
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Radiation-Emitting Product Regulation

The U.S. Food and Drug Administration gained authority to regulate all radiation-emitting products in the United States under the Radiation Control for Health and Safety Act of 1968 and the Federal Food, Drug and Cosmetic Act (FDCA). Section 532 of the FDCA authorizes the FDA to carry out an electronic radiation control program designed to protect public health and safety from radiation that may be emitted from electronic products sold in the United States.
This authority extends to many types of products, including products related to medical imaging, surgical and therapeutic products, home, business and entertainment products, security systems and even tanning products. Some specific examples include:

  • Medical Lasers
  • Mammography
  • Medical x-ray imaging
  • Microwave ovens
  • Security systems
  • Sunlamps and sunlamp products
  • Ultrasound imaging
  • Laser products and instruments
  • Laser light shows
  • Televisions and video display monitors
  • Compact fluorescent lamps

This authority extends to almost all actors in the supply chain – manufacturers, assemblers and importers of electronic products.

If you are involved in the manufacture or importation of any radiation-emitting products or radiation-emitting medical devices, it is important that you understand all legal regulatory requirements before you bring your product to market. Failure to do so can result in FDA detentions, refusals, seizures, import alert listings, and harm to your brand image. Our attorneys can help you:

  • Review product design and discuss applicable established performance standards set forth in regulation
  • Review quality control requirements during manufacturing to assure your product is manufactured under specific standards
  • Understand certification requirements
  • Submit product reports to the FDA to demonstrate compliance with applicable standards – including obtaining accession numbers
  • Audit your operations and risk assessment related to non-compliance
  • Review labels and labeling, including required warning information
  • Provide U.S. agent services
  • Counsel on adverse event reporting and liability control
  • Review notification requirements
  • Manage inspection of electronic emitting product manufacturers
  • Review Standard Operating Procedures (SOPs)
  • Ensure compliance with current Good Manufacturing Practices (cGMPs) and best practices
  • Conduct new product reviews
  • Obtain variances and exemptions from the FDA when a new product does not fit existing performance standards
  • Defend against FDA and FTC enforcement actions such as product recalls, FDA detentions and refusals, warning letters, 483s, adulteration and misbranding charges, import alerts, or claims brought by state and federal prosecutors for violation of safety regulations, and for false labeling and advertising
  • Review U.S. Customs matters such as Form 28s, liquidated damages, criminal investigations, seizures, HTS classifications, free trade agreements, country of origin issues, and import/export guidance
  • Analyze and advocate with respect to relevant legislation and regulatory matters
  • Obtain patents and trademarks and offers gray market protection strategies