Many medical devices, both existing and new designs, are laser-based. For some time, lasers have been designed into medical devices from diagnostic, imaging, and therapeutic systems, to invasive treatment designs like those for cauterization, surgical cuts, ophthalmic surgery, and so on. Many of these invasive types are designed with powerful lasers (21 CFR Class IV, IEC Class 4), meaning that they are the most hazardous laser radiation levels, and appropriate engineering and administrative safety controls must be employed.
All laser products are divided into hazard classes: for example, IEC Class 1 through 4. Class 1 is considered the safest, and Class 4 the most hazardous. A Class 1 laser product means that the operator does not have access to the laser radiation, or the accessible laser radiation is Class 1 (not hazardous). A Class 4 laser product means that the operator can access the most hazardous laser radiation levels, which are classified as an acute hazard to the skin and eyes, and can also be a fire hazard. (See Figure 1)
In order for laser-based electronic products including medical devices to enter US and global commerce, manufacturers must meet specific safety regulations and safety standards. Chief among these are Title 21 U.S. Code of Federal Regulations (21 CFR), Food and Drugs, and IEC60825-1, Safety of Laser Products – Part 1: Equipment classification and requirements. There are other important safety standards for consideration by medical device manufacturers, including but not limited to: IEC 60601-1, IEC 60601-2-22, ANSI Z136.1, IEC 62471 and ISO 15004. This article specifically highlights 21 CFR and IEC 60825-1 as the gateway for laser-based medical products to enter the US and global marketplace.
21CFR Safety Regulations
Under the auspices of the U.S. Department of Health and Human Services (HHS) is the Food and Drug Administration (FDA), and the Center for Devices and Radiological Health (CDRH). The CDRH, an organizational component of the FDA, is responsible for regulating radiation-emitting electronic products. In the US, the regulations for all laser-based products, including those for medical devices, are governed by 21 CFR. All laser-based products marketed in the US must be classified according to their output levels and meet 21 CFR regulations. (See Figure 2)
Any product that contains an electronic circuit and generates any kind of ionizing or non-ionizing radiation is considered a radiation-emitting electronic product. The FDA’s statutory authority to regulate these products is granted by the United States Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C, Electronic Product Radiation Control.
21 CFR Subchapter H covers Medical Devices, and Subchapter J covers Radiological Health – radiation safety regulations for manufacturers of radiation- emitting electronic products. Part 1040 specifically covers laser products. 21 CFR is, “…a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.” To determine whether 21 CFR has been revised since its last revision date, the Reader Aids sections of the daily Federal Register can be consulted. See www.federalregister.gov .
Manufacturers intending to enter their laser products into US commerce are required to certify and report their product to the CDRH. The laser products to be introduced into the US or imported as such must be certified and identified in accordance with 21 CFR Sections 1010.2 and 1010.3, be reported in accordance with 21 CFR Section 1002.10, and comply with 21 CFR Sections 1040.10 and 1040.11, as applicable. If a mandatory radiation safety performance standard applies to a manufacturer’s product, then the manufacturer must also comply with 21 CFR 1010, Performance Standards for Electronic Products.
Regarding certification, every manufacturer of an electronic product shall furnish to the dealer or distributor certification that the product conforms to all applicable standards under the subchapter. It is important to note that 1010.2 goes on to say that, “Such certification shall be based upon a test…” Section 1010.3 covers product identification.
Laser-based products must also comply with 21 CFR Sections 1040.10 and 1040.11 – Laser products, and Specific purpose laser products, respectively. It is important to note that according to 21 CFR Part 1000, a manufacturer means any person engaged in the business of manufacturing, assembling, or importing of electronic products. Section 1040.10 covers definitions, classification of the laser product, accessible emission limits for laser radiation, tests for determination of compliance and certification, construction and performance requirements, and labeling and informational requirements.
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.
Looking further into CDRH’s position in LN50, CDRH will not object to conformance with the comparable sections of IEC 60825-1, Editions 1.2 or 2 or 60601-2-22 in lieu of conformance with a number of 1040.10 Sections of 21 CFR including but not limited to definitions, classification, AELs, tests, construction and labeling requirements, user information and 1040.11(a) Medical laser products. This intention of CDRH is to harmonize these sections with the applicable IEC standards, IEC 60825-1 and IEC 60601-1-22. It is important to note, however, that a number of Part 1040 sections are intended to not be harmonized with IEC and those include, among others, 1010.2 Certification, 1010.3 Identification, 1010.4 Variances, and 1040.11(c) Demonstration laser products.
LN50 is extremely important to manufacturers of laser-based medical devices because a product can now be tested and evaluated to the IEC requirements and the results can be used to develop the CDRH Product Report for submission to the CDRH and product entry into US commerce. The same test data can be used to develop the required IEC Test Record Format for product entry into those countries outside of the US that require conformance to IEC 60825-1 and IEC 60601-2-22. The end result is that the CDRH’s “least burdensome approach” is moving toward one set of requirements applicable in both the US and Europe, and lightens the regulatory burden for manufacturers. So, in effect, invoking LN50 should reduce overall third-party test and evaluation costs, and turn around time to global market entry. LN50, however, does not exempt manufacturers from filing a Product Report with the CDRH.
Further CDRH Harmonization with IEC Is Planned
The FDA issued Docket FDA-2011-N-0070 on June 24, 2013, in the Federal Register proposing changes to 21CFR Part 1040 to advance further harmonization with IEC 60825-1 Edition 2. The comment deadline was in the late third quarter of 2013. At the time of this writing, the FDA is in the process of addressing comments on the docket and the replies will be published in the Federal Register. Some will be used as a basis for making revisions to the proposed regulations.
IEC 60825-1 Ed. 2 was published in 2007. Since that time, a new Edition 3 has reached the IEC Final Draft International Standard (FDIS) stage, and in Q1 2014, the present version of the FDIS has been approved. There are some changes from Ed. 2 to Ed. 3 that are important for medical device manufacturers such as the new Class 1C.
This article was written by Peter J. Boden, Biomedical Engineer, MS, Executive Consultant, Laser Product Safety, LLC, Cary, NC. For more information visit http://info.hotims.com/49749-162 . The author would like to thank Ken Puckett, Laser Product Safety, LLC, for technical support of this article.