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.
- Has Stevia been approved by FDA to be used as a sweetener?
- FDA Basics Webinar: FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA
- What can I do to help ensure I do not receive or take counterfeit medicine?
- Is there lead in lipstick?
- Vaccines for Use During Pregnancy to Protect Young Infants from Disease – FDA Update
- FDA Basics Webinar: Practice the art of sun protection
- FDA Basics Webinar: "Mini-Sentinel," FDA's New Tool for Monitoring the Safety of FDA-Approved Medical Products
- FDA Basics Webinar - April 27, 2015: Drug Trials Snapshots
- FDA Webinar on Prescription Drug Shortages
- When previously recalled products are back on the shelves, how can I be sure that it is okay to buy them?
- What do consumers need to know about the recall of shell eggs?
- What is FDA Basics for Industry?
- FDA Basics Webinar- August 31, 2015: Food Safety: Bad Weather Basics
- July: CBER's Direct Recall Classification Program
- FDA Basics Webinar, June 17, 2013: Biological Products: Part 1
- Is it true that "OTC (Over the Counter)" products can prevent SIDS?
- FDA's Pesticide Program
- Recall Process for FDA-Regulated Products
- Where can I find information about adverse reactions to a medicine prescribed for my child?
- Where can I find information about medicines prescribed for my child?
- FDA Webinar on Protecting Your Child's Health Through Safe and Effective Vaccines
- FDA Webinar on Safety of the Blood Supply
- How did the Federal Food, Drug, and Cosmetic Act come about?
- Materials from Webinar on Access to Investigational Drugs
- How do I find the latest information on the Web site? How do I sign up for e-mails and alerts?