IS YOUR PRODUCT REGULATED BY FDA? IF IT’S ELECTRONIC, IT MAY BE
Partner
Introduction
Almost everyone knows that the U.S. Food and Drug Administration (FDA) regulates food, drugs, cosmetics, medical devices and even tobacco products. We see references to FDA and these types of products all the time in TV news reports, articles, and even on social media. We hear about recalls, FDA product approvals, and newly issued Agency requirements for these types of articles on a regular basis. However, FDA also has lesser known regulatory requirements for other types of products as well. One important example is radiation-emitting electronic products (electronic products). For electronic products, FDA’s goal is to protect the public from hazardous and unnecessary exposure to radiation from these products. Despite a full FDA regulatory regime for electronic products, many medical and non-medical companies, making and marketing electronic products, do not realize that there are FDA requirements in this area. This lack of knowledge can lead to legal and business problems.
FDA Definitions and Regulatory Regime
FDA’s authority to regulate electronic products is found in the Federal Food, Drug, and Cosmetic (FDC) Act, Sections 531 through 542 (21 U.S.C. 360kk-360ss), and in FDA implementing regulations at 21 C.F.R. Parts 1000 through 1050. In this area, FDA regulates manufacturers, distributors and dealers of electronic products.
An “electronic product” is defined as any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation:
- Contains or acts as part of an electronic circuit; and
- Emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.
“Electronic product radiation” is defined as any ionizing or non-ionizing electromagnetic or particulate radiation, or any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.
These two broad definitions lead to one significant result: A very large number of consumer and other product types are subject to FDA’s electronic product requirements. While far from an exhaustive list, the following examples of electronic products illustrate the far-reaching range of products that are FDA-regulated in this regard:
- X-ray machines (industrial, medical, research, educational);
- Electron microscopes;
- Biochemical and medical analyzers;
- Tanning and therapeutic lamps and beds;
- Certain sanitizing and sterilizing devices;
- Welding equipment;
- Various alarm systems;
- Dryers, ovens, and heaters.
- Police radar scanners;
- Remote control devices;
- Diathermy units;
- Laser products (DVD and BluRay products, laser pointers, light shows, and other experimental, medical and educational laser products)
- Certain cutting and drilling devices;
- Electronic oscillators;
- Sound amplification equipment;
- Ultrasonic cleaners;
- Video displays;
- Cell phones and other wireless devices; and
- Magnetic resonance and radiation therapy systems
Under the FDC Act, a “manufacturer” is defined as any “person engaged in the business of manufacturing, assembling or importing electronic products.” Please note that the definition includes “importers” of electronic products. Importers can be held responsible for meeting FDA requirements for electronic products that they import. FDA also places obligations on dealers and distributors of electronic products. They must comply with certain record keeping requirements so that electronic product customers can be found and notified as necessary, e.g., in the event of a product replacement, repair or refund action.
FDA has issued radiation safety standards as regulations, which have the force and effect of law, that apply to many electronic products. The standards establish design, performance, testing, and labeling requirements that are meant to guard against the public being exposed to harmful radiation emissions. These safety standards are contained in 21 C.F.R. Parts 1010 through 1050. Relevant electronic products must meet the requirements of its applicable safety standard before shipment for U.S. commercial distribution. Manufacturers need to certify their electronic products comply with any applicable FDA safety standard. Importers must provide an FDA-prescribed certification statement as part of the U.S. import process.
In addition, manufacturers are required to establish a quality control inspection and testing program at their facilities. The program is meant to demonstrate and provide evidence that each electronic product unit that is produced complies with its applicable safety standard.
In general, manufacturers of electronic products, that are subject to a safety standard, must file reports with FDA that describe the manufacturer, the product, its specifications for radiation safety, any product labeling, and its quality control inspection and testing program. FDA assesses product compliance and quality control inspection and testing programs by reviewing the reports. The report must be filed before U.S. commercial distribution of the product. The regulations at 21 C.F.R. Part 1002 contain this reporting requirement and other reporting and record keeping requirements.
There also are regulations for product identification, product corrective actions and other topics.
Discussion
If you market an electronic product, and you have not looked into whether it is subject to FDA regulation, you should make that determination. If your product is regulated, you need to understand whether your product needs to comply with an FDA radiation safety standard and what other FDA requirements apply. Noncompliance can subject you to FDA penalties and enforcement action and increase your product liability exposure. Noncompliance also can cause import delays and refusals of import admission.
For more information, contact Neil at neil@amintalati.com or 312-784-1067.
