22.5.1 Medical Device Studies (Investigational Device Studies) There are many different types and intended uses of medical devices. Medical devices are implants (i. e., pacemaker), devices to monitor a user (i. e., blood pressure cuff), devices to sustain human life (i. e., ventilator) or devices important in diagnosing, curing, or treating a disease. Other medical […]

The standard specifies performance requirements according to the Class of the laser product and the accessible laser radiation. Note that, where the standard requires a particular performance feature, the feature must be readily identifiable as such on the product. Failure to properly identify required features may lead to difficulties in determining product com­pliance. The applicability […]

Each laser product is classified as Class I, IIa, II, IIIa, IIIb, or IV in accordance with defi­nitions established by FDA in paragraphs (b)(5) through (11) of 21 CFR §1040. The product classification is based on the highest accessible emission level(s) of laser radiation to which human access is possible during operation. Lasers are classified […]

It is important to note that the FDA only regulates the sale and marketing of medical devices and does not regulate physicians or nurses in the practice of medicine or in the use of a device. Before a laser can be legally sold in the United States, the company wishing to sell or market the […]

The term ‘laser’ is an acronym for ‘Light Amplification by Stimulated Emission of Radiation’. Simply stated, a laser tool emits a beam of light which, when focused on a substrate, will thermally affect its target. This is made possible because of the way lasers interact with electrons. There are many different types of medical lasers, […]

Particularly pertinent for lasers, any device that emits radiation must additionally com­ply with the Radiation Control for Health and Safety Act passed in 1968,72 which is also administered by the FDA and which authorizes the development of performance standards and general controls for ionizing radiation products. The Act was designed to protect the public from […]

Manufacturers and distributors of products meeting the definition of “electronic product radiation” in Section 531 of the FDCA may be subject to certain provisions of the Act includ­ing the retention of records and submission of product reports to the FDA, specifically to the Center for Devices and Radiological Health (CDRH). The FDA requirements for these […]

• Basis for classification of surgical laser devices • Laser standards FDA regulates radiation emitting electronic products. The purpose is to prevent unneces­sary exposure to radiation due to the use of these products. There are specific requirements that apply to all radiation-emitting electronic products in order to comply with the provisions of the Food, Drug […]

PMA requirements apply to Class III preamendment devices, transitional devices, and postamendment devices. a. Preamendment Devices. A preamendments device is one that was in commercial distribution before May 28, 1976, the date the Medical Device Amendments were signed into law. After the Medical Device Amendments became law, the classification of devices was determined by FDA […]