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.