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 laser must obtain authorization from the FDA. Medical lasers, depending on their application, are usually categorized in Class II or IV77 and must have premarket approval or premarket clearance from the FDA prior to marketing for any indication. The majority of lasers are cleared through the 510(k) premarket application process. However, there are two minor exceptions to this. Certain unapproved, nonsignificant risk Class III medical devices may be distributed in the United States to individual practitioners who have approval from an Institutional Review Board (IRB) for the investigational clinical use of the device. Alternatively, lasers may be distributed to investigators participating in a study under an IDE approved by the CDRH78 (although various IDE requirements need to be complied with79).
By way of further regulatory rigor, all laser devices distributed for both human and animal treatment in the United States are subject to Mandatory Performance Standards. Laser manufacturers therefore have to meet the federal laser product performance standard and must submit an initial report to CDRH’s Office of Compliance prior to distributing the laser.80 This performance standard specifies the safety features and labeling that all lasers must have, in order to provide adequate safety to users, and includes various technical and service requirements. A laser product manufacturer must certify that each laser model has passed a quality assurance test and complies with the performance standard before introducing the laser into the market. This includes distribution for use during clinical investigations prior to device approval.
The company/manufacturer certifying a laser assumes responsibility for product reporting to CDRH,81 record-keeping, and notification of defects, noncompliances, and accidental radiation occurrences.82 However, once the FDA has authorized the commercialization of a laser, a doctor may decide to use that laser for other indications if he/she feels it is in the best interest of a user. The use of an approved device for other than its FDA-approved indication is called off-label use. The FDA does not regulate the practice of medicine.83 Therefore, the FDA does not have the authority to regulate a doctor’s practice and activities. The FDA does, however, regulate the claims manufacturers assert for their devices.