Manufacturers are required to maintain records and submit specific reports to the CDRH for products that emit radiation. Part 1002 Subpart A, Table 1 – Record and Reporting Requirements by Product, addresses the specific class of laser radiation (I, IIa, II, IIIa, IIIb, IV). Table 1 addresses the following Reports: Product, Supplemental, Abbreviated, Annual, Test Records, and Dealer and Distributor Records. A Product Report must be submitted to the CDRH before a laser-based product is entered into US commerce. When a Product Report is received by CDRH, a unique identification number called an Accession Number is assigned to the report.
Some states also have regulations for the safe use of laser products, and should be consulted regarding safety, reporting, and record-keeping.
IEC60825-1 Second Edition 2007-03, Safety Requirements
Outside of the US, the driver for laser-based product entry into the global marketplace is compliance with the standard IEC 60825-1, Safety of Laser Products. The objectives of IEC 60825-1 include: a system of classification of the laser radiation according to the hazard to skin and eye; requirements for manufacturer information; labels, instruction, and warnings; and hazard control measures. IEC 60825-1 references other applicable safety standards including medical laser products. Clause 7.2 states, “Each medical laser product shall comply with all of the applicable requirements for laser products of its class. In addition, any Class 3B or Class 4 medical laser product is subject to IEC 60601-2-22.”
Harmonization Benefits Manufacturers
As mentioned, in the US, compliance with the regulations for laser-based products is mandatory if the product is to be marketed in the US. In this case, 21 CFR applies. Many manufacturers of laser-based medical products, however, wish to market their products globally, and this is where CDRH’s Laser Notice 50 comes into play on behalf of the manufacturer.
The CDRH issues Laser Notices (LN), which represents the FDA’s current thinking on a specific topic. To date, 55 LNs have been issued. For the scope of this article, two important Laser Notices that warrant mention for laser-based medical products are LN44 issued in 1995, and LN50 issued in 2001.
LN44 – User Instructions for Medical Laser Products acknowledges that medical laser products are varied in their construction, configuration, and intended use. This makes it difficult to determine the necessary precautions to avoid possible exposure to hazardous levels of laser radiation to the user and those in the vicinity of use. LN44 mentions that CDRH recognizes that the standard ANSI Z136.1 – Safe Use of Lasers, is a widely accepted laser safety standard in the US, and can be relied upon for a heightened level of safety regarding hazard zones in the vicinity of laser equipment, personal protective equipment, such as protective eyewear, and the responsibilities of laser safety officers.
LN50 – Guidance on Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22 describes the conditions under which laser product manufacturers may introduce into US commerce laser products that comply with the IEC 60825-1, Safety of Laser Products – Part 1: Equipment Classification and Requirements, as amended, and 60601-2-22, Medical Electrical Equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment. (See Figure 3)
LN50 describes additional requirements of CDRH and alternate certification statements to be used with such products. The general premise of LN50 is that the, “CDRH will not object to conformance with many sections of IEC 60825-1, as amended, and IEC 60601-2-22 as alternatives to comparable 21 CFR Sections 1040.10 and 1040.11.”
CDRH’s Least Burdensome Approach
The CDRH’s published position is that they “…should consider the least burdensome approach in all areas of medical device and electronic product regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements.”
CDRH plans to amend federal regulations for laser products to reflect those sections of the IEC standards. In addition, CDRH is listing sections of its standard that contain requirements to which manufacturers must conform. This action is appropriate because of the CDRH’s intent to harmonize its requirements with many of those of the IEC standards. This means that CDRH is moving toward further harmonization with the applicable 21CFR regulations and IEC laser safety standard requirements including IEC 60825-1 and the IEC 60601-2-22 medical electrical equipment standard. LN50 is one of the first efforts toward this harmonization effort regarding laser-based products.