Overview of CDRH
The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulate the manufacture of radiation emitting electronic products. The CDRH is an organizational component of the FDA that has been given the legal authority to regulate these products under the United States Federal, Food, Drug and Cosmetic (FD&C) Act, Chapter V, Subchapter C, Electronic Product Radiation Control.
The purpose of the FD&C Act is to protect the public from hazardous and unnecessary exposure to radiation from electronic products. There are general requirements that apply to all radiation emitting electronic products and additional requirements specific to certain types of products. If the product is also a medical device, the product must also comply with the medical device regulations.
Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits radiation. Lasers are just one type of electronic product that emits radiation. Manufacturers. distributors, and importers of laser products may be subject to certain requirements created under the FD&C Act.. The Food and Drug Administration (FDA) requirements for these products, including requirements for record keeping and reporting, are included in the final regulations contained in Title 21 Code of Federal Regulations Parts 1000-1299 (21 CFR 1000- 1299). According to section 531 of the FD&C Act.
These requirements are commonly referred to as the CDRH requirements. The requirements specific to laser products are referred to as the Federal Laser Product Performance Standard or "FLPPS".
Compliance to these regulations is required by Federal law. Delivery of a non-compliant product is not allowed. Non-compliance can result in severe penalties including; importation denied, sale of product prohibited,
recall, repair, and/ or replacement required of every non-compliant unit unit, fines up to US$300,000.00.
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