• Components of a 510(k) application
• Special requirements for OTC clearance
A brief summary of those requirements outlined under the Radiation Control for Health and Safety Act of 1968 that apply to manufacturers of laser products are presented here. The reader is encouraged to review the regulations in their entirety to foster complete comprehension of the requirements before making any design or procedural decisions.
The following definitions are basic to the regulations:
A laser is a device capable of producing or amplifying electromagnetic radiation in the wavelength range from 180 to 1 x 106 nanometers110 by the process of controlled, stimulated emission.
A lasersystem111 consists of a laser in conjunction with its power supply.
A laserproduct112 is any device that constitutes, incorporates, or is intended to incorporate a laser or laser system.
A manufacturer113 is any person or organization in the business of making, assembling, or importing laser products. Responsibilities of the laser manufacturer include:
• design and manufacture their products to be in compliance with the standard,
• test their products to assure compliance;,
• certify compliance of their products;
• maintain test and distribution records and a file of correspondence concerning radiation safety, safety complaints, and inquiries;
• use the published reporting guides to submit reports to CDRH, including the Initial and Model Change Reports describing compliance of the product design and testing program and Annual Reports summarizing required records;
• report accidental radiation occurrences (i. e., possible, suspected, and known exposures);
• report any radiation defects or noncompliances; and
• recall (i. e., repair, replace, or refund the purchase price of) defective or noncompliant products.