Are medical devices regulated for non-medical reasons?
Yes, if the device is an electronic product that emits (or if unshielded, would emit) electronic product radiation. Manufacturers of such electronic products should be aware that certain radiation protection requirements and recommendations exist under 21 CFR Subchapter J - Radiological Health.
Medical devices are just a subset of electronic products that may have general regulatory provisions. Some electronic product manufacturers have specific performance, reporting, and recordkeeping standards that must be met before and after their electronic products enter into commerce. Examples of the types of electronic product radiations that are regulated include x-rays and other ionizing radiation, ultraviolet, visible, infrared, microwave, radio and low frequency radiation, coherent radiation produced by stimulated emission, and infrasonic, sonic, and ultrasonic vibrations.
Specific electronic product performance standards exist for medical device electronic products that emit (or would emit) such radiation, for example; x-ray machines, accelerators, neutron generators, biochemical and medical analyzers, medical laser products, sanitizing and sterilizing devices, diathermy units, medico-biological heaters, cauterizers, biomedical analyzers, and ultrasound. Examples of other electronic products are microwave ovens, tanning beds, radar devices, alarm systems, non-medical lasers, etc.
Go to the FDA Basics Radiation-Emitting Products page for more information.
- FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA
- FDA Basics Metrics: August 2014
- FDA Basics Metrics: July 2014
- FDA Basics Metrics: June 2014
- What Should I Do If I See Violations of FDA’s Tobacco Products Rules?
- FDA Basics Webinar June 30, 2014: Over-The-Counter Medicines and Driving
- Webinar Friday, May 23 - Packing A Healthy Lunch
- Where do I go to report problems with flea and tick products?
- What does FDA regulate?
- Webinar Tuesday, May 13 - Temporary Tattoos: Raising Consumer Awareness of Safety
- FDA Basics Metrics: May 2014
- FDA Basics Metrics: April 2014
- Who can I contact if my question wasn’t answered or I have additional questions in the future?
- FDA Basics Metrics: March 2014
- FDA Basics Metrics: February 2014
- What is the Reportable Food Registry?
- How do I report a complaint about food bought in a supermarket?
- What Rules Apply to Persons that Want to Start a Food Business?
- Is "over the counter (OTC)" medication safe for my child?
- FDA Basics Metrics: January 2014
- What does FDA inspect?
- When and why was FDA formed?
- What is a biological product?
- FDA Basics Metrics: December 2013
- FDA Basics Metrics: November 2013
How helpful was this information?