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Tag: medical device regulations

Regulations for Medical Devices in America

Regulations for Medical Devices in America

In America, the FDA’s Center for Devices and Radiological Health, or CDRH, is responsible for regulating the firms that manufacture, repackage, relabel, or import medical devices that are sold in the United States. It also regulates electronic products that emit radiation. These products include lasers, x-rays, ultrasounds, microwaves, and color televisions.

Radiation-emitting Electronic Products

Medical devices are broken down into three classes, Class I, Class II, and Class III. Class I has the least amount of regulatory control and are exempt from having to submit a Pre-market Notification 510(k) for approval. Class II devices; however, require Pre-market Notification 510(k). Class III devices require Pre-market Approval and the approval of two groups.

Who Regulates Medical Devices?

FDA Approved
FDA Approved

The FDA, or Food and Drug Administration, is an agency inside the U.S. Department of Health and Human Services. It makes up the office of the Commissioner and the four directorates oversee the core functions of the agency. From medical products and tobacco, to food and veterinary medicine, it helps to regulate operations for many industries in America.

Federal Drug Administration

The Federal Drug Administration is responsible for many things. First is being the regulator of tobacco. Beyond that, the FDA aids the protection of public health by making compliance regulations for the medical field, food service industry, and many more important parts of everyday life for American citizens.

Regulations for Medical Devices

Regulations for Medical Devices
Regulations for Medical Devices

Medical devices can be anything from highly refined computerized medical equipment down to a wooden tongue depressor. There are multiple international classification components to categorize medical devices. The World Health Organization, or WHO, with partners, are working toward accomplishing global harmonization in medical device terminology in hopes of bringing a global standardization.

GHTF

The Global Harmonization Task Force proposes the following definition for medical devices: A medical device is any instrument, implement, apparatus, machine, implant, appliance, in vitro reagent or calibrator, software, or related article, as intended by the manufacturer to get used in combination or alone on humans for the specific purpose of: