Let’s say you need to develop a product that will be accepted in the United States as well as globally. What standards do you use? Fortunately, the world is harmonizing. So, your team usually will be able to select key standards that will, with some small tweaks, apply globally. Let’s walk through the steps for identifying standards in the United States and discuss how to expand to a global approach.
In the United States, identifying predicate devices and their compliance claims is key. You may be using one of your own devices as the predicate, or you may need to search FDA’s database of cleared or approved products and review the relevant summary statements to determine the compliance claims. Once you have the list of predicate claims, you need to dig a little deeper. FDA’s “Frequently Asked Questions on Recognition of Consensus Standards” (2007) explains that older standards may not be appropriate for new submittals; therefore, you should review the current list of FDA’s consensus standards to find current equivalents and any FDA comments or exceptions to the standards.
Once you have the list of standards for the FDA submission, you should consider country deviations. For example, FDA recognizes IEC 60601-1:1988, but to ensure wide acceptance in the United States you will want to consider UL 60601-1, which contains all the requirements of IEC 60601-1 and additional requirements based on the U.S. electric and fire codes (NEC, NFPA 99). (In some cases, FDA is open to accepting the most recent edition, such as IEC 60601-1:2005 in this example. For IEC 60601-1:2005, the U.S. deviations are included in AAMI ES 60601-1.) Compliance with the country deviations will help ensure the ability to achieve private test marks and facilitate acceptance by hospital biomedical engineers. Similar deviations exist for Canada (CSA 60601-1) and other countries.
The good news is that many of FDA’s consensus standards are international standards that are accepted globally. Equivalent to FDA’s list of consensus standards is Canada’s list of recognized standards, Europe’s list of harmonized standards, and so forth.
A senior consultant for Noblitt & Rueland, Christine Ruther has extensive experience assisting manufacturers in safety-critical areas of compliance and regulatory engineering for electronic and wireless medical devices. She was manager for medical device testing at TUV Product Services, where her responsibilities included ISO/CE marking auditing. Ruther has worked in industry as senior compliance engineer and manager and as director of product development and regulatory affairs including responsibilities for product failure analysis. She works with medical device manufacturers, from start-ups through Fortune 500 companies, as well as with government agencies such as NIST and ANSI. Her knowledge of global regulations and standards includes MDD, R&TTE, IEC, ISO, AAMI, FDA, and FCC, and is coupled with extensive experience in risk management and design control. Ruther received a BS in physics (Xavier University) and MS in biomedical engineering (Ohio State University). She volunteers for IEEE and Orange County Regulatory Affairs (OCRA). For more information about Noblitt & Rueland, which provides consulting and training services for medical device and IVD manufacturers, view its listing in the Consultants Directory or go to the company’s Web site at www.fdaconsulting.com