FDA Regulations: What do they have to do with treatment devices?

FDA’s Center for Devices and Radiological Health is responsible for radiation therapy treatment aids.

The FDA’s (Food and Drug Administration’s) Center for Devices and Radiological Health is responsible for regulating all companies that either manufacture, relabel, or import medical devices in the United States. Medical Devices are classified into Class I, II, and III. The regulatory control increases as you progress from Class I to Class III.

The code of Federal Regulations Title 21, Part 807, 21 CFR Part 807, states that all manufacturers must register their establishments with the FDA, verifying all information annually, and must also list their devices with the FDA. Regulations cover everything from proper labeling, testing, pre-market notification and pre-market approval and a myriad of other regulations that cover the safe and effective use of products used on humans. Smithers Medical Products, Inc. has registered with the FDA and registered its products with the FDA. SMP has also had on-site inspections from the FDA and the FDA representative commended us on our facility and operations.

Different facilities sometimes go to hardware stores and purchase construction hardware supplies to create devices on humans, unaware of the physical dangers they place on their staff as well as their patients. Besides the inherent dangers in using these toxic chemicals indoors, it is a violation of federal law to use these chemicals which were never designed for use on cancer patients in a hospital setting. It is a requirement to follow quality system regulations, 21 CFR Part 820, relating to methods used in manufacturing, designing, storing and installing and servicing medical devices.

Depend on quality companies that you can trust to provide you with tried, field tested and patented medical products for your patients. With SMP’s Alpha Cradle® brand, this is exactly what you get. From our state of the art solid state dispensing equipment to our self-calibrating electronic scales that are accurate to the nearest tenth of a gram, SMP goes above and beyond to provide you with the highest quality product. We are also the only medical manufacturer in the world to use accordion-style bottles with our foaming agents–just one more level of safety built into every set of foam we provide.

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