How does FDA regulate Radiation Emitting Medical Device?
Jun 15 2022
Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits radiation.
These include a variety of medical and non-medical products such as X radiation (x-rays), microwaves, radio waves (radiofrequency (RF)), ultrasound, and ultraviolet light, mammography devices, magnetic resonance imaging (MRI) devices, laser products.
Legal definitions of the terms "electronic product radiation" and "electronic product" are located in the Federal Food, Drug, and Cosmetic Act, Chapter 5, Subchapter C - Electronic Product Radiation Control.
Regulatory Authority over the manufacture and use of Radiation-Emitting Electronic Products
The United States (U.S.) Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating radiation-emitting electronic products. The CDRH goal is to protect the public from hazardous and unnecessary exposure to radiation from electronic products. For most electronic products, safety regulation is divided between CDRH and state regulatory agencies. CDRH regulates the manufacture of the products, and the states regulate the use of the products.
*** Note : Manufacturers may be subject to additional FDA regulations if their product is intended to be used in a medical application (Medical Devices) or for irradiation or inspection of food (Title 21 CFR 179 Food Irradiation).
Q. What gives FDA the authority to regulate manufacturers of radiation-emitting electronic products and what are the regulatory requirements?
The FDA's statutory authority to regulate radiation-emitting electronic products is granted by the United States Federal Food, Drug and Cosmetic Act, Chapter V, Subchapter C, Electronic Product Radiation Control.
Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 through 1050 (21 CFR 1000 – 1050) contains radiation safety regulations for manufacturers of radiation-emitting electronic products.
Manufacturers are responsible for producing products that do not emit hazardous and unnecessary radiation. All manufacturers must comply with the applicable requirements in Title 21 CFR 1000, 1002, 1003, 1004 and 1005. If a mandatory radiation safety performance standard applies to a manufacturer's product, then the manufacturer must also comply with Title 21 CFR 1010 and the product must comply with the requirements of the standard.
Mandatory radiation safety performance standards are found in 21 CFR 1020 – 1050.
FDA Approval of the certification of product
Certification is a manufacturer's statement that indicates its product complies with the applicable standard. The manufacturer is responsible for assuring the certification (21 CFR 1010) that a product complies with an applicable standard is true to the best of its knowledge. This statement of certification must be based on a quality control and testing program which can demonstrate that each product manufactured complies with the applicable standard.
Q. We make thousands of products a year; do we have to test each one?
Not necessarily. When appropriate, you may use a statistically valid sampling plan as a part of your quality control and testing program. Any sampling plan must conform to appropriate consensus standards on quality control sampling.
Q. When am I allowed to sell my product in the United States?
You may sell your product when you have assured your product does not emit hazardous and unnecessary radiation. Additionally, if there is an applicable mandatory federal radiation safety performance standard:
Your product must comply with the applicable standard;
You must establish a testing and quality control program sufficient to prove your product is completely compliant with its applicable standard (Title 21 CFR 1020 through 1050);
Your product must have certification and identification information permanently affixed or inscribed as required in the general performance standard (Title 21 CFR 1010). You may only place a certification label on a product if your certification is based on an adequate quality control and testing program. The certification label is your statement that your product conforms to the applicable standard (Title 21 CFR 1010.2).
Q. I want to import a medical laser product (or other medical radiation-emitting product), what do I need to do to get it approved for U.S. market?
Because they are medical devices, they must also comply with the medical device regulations, establishment registration, and device listing requirements.
For more information, see the Device Advice: Comprehensive Regulatory Assistance webpage, "How to Study and Market Your Device."
Q. Are imported devices entering the U.S. under an FDA approved Investigational Device Exemption (IDE) also exempt from complying with performance standards under the Radiological Health program?
No, they must comply with applicable radiation standards. An approved IDE does not affect products subject to U.S. Federal performance standards. Noncompliant radiation emitting electronic medical products (such as medical x-ray, medical laser, and therapy ultrasound) subject to a standard cannot be legally imported and/or distributed and used domestically under an IDE for clinical studies because the performance standards already exist for these products.
Medical devices that are also radiation-emitting products must comply with both medical device regulations as well as electronic product regulations. Electronic product regulation 21 CFR 1010.1 states the standards listed in that subchapter are prescribed pursuant to performance standards under section 534 of the Food, Drug, & Cosmetic Act.
Therefore, although an IDE would provide exemptions from section 514 (medical device performance standards), it does not exempt manufacturers from section 534 (electronic product performance standards), which means those regulations in 21 CFR 1000 - 1050 must still be followed for radiation emitting products used in clinical studies conducted following an approved IDE. The product must nevertheless comply with the applicable standard(s), be certified, and a completed and accurate product report must be submitted to CDRH before the product is released to the importer and clinical investigators, as required by 21 CFR 1002.10.
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