For manufacturers of in vitro diagnostic (IVD) instruments, FDA requirements are usually the main focus. The FDA does decide market access – for example through a 510(k) or PMA – and therefore whether a product may legally be sold. Yet many IVD manufacturers overlook another key requirement once FDA clearance is in hand: NRTL safety certification.
FDA clearance addresses the safety and effectiveness of the device under medical device law, but it does not certify electrical product safety to the applicable US safety standards. In US hospitals and laboratories, electrical equipment used in the workplace falls under OSHA (Occupational Safety and Health Administration) rules and local electrical codes, which in practice require equipment to be listed by a Nationally Recognized Testing Laboratory (NRTL). Almost all US hospitals and most healthcare facilities therefore require an NRTL mark when purchasing equipment; clinical engineering departments accept only certified devices.
So even an IVD instrument with FDA clearance may not be installed in a hospital without NRTL certification.
Many companies have learned this the hard way. Some IVD manufacturers obtained 510(k) clearance and shipped instruments to the US on schedule, only to be told during hospital acceptance that the safety mark was missing and the devices could not go live. Rushed certification delayed projects, caused high expedited-testing costs and even damaged reputations.
IVD companies planning to export to the US should therefore plan NRTL certification in parallel with FDA registration. Ideally, design to the applicable safety standard from the development phase – for laboratory equipment usually UL/IEC 61010-1 – and schedule certification testing early. Then safety certification is ready by the time FDA clearance arrives.
Common NRTLs: options besides UL
Besides UL, around 20 laboratories are recognised as NRTLs by OSHA. All of them can provide product safety certification equivalent to UL. Some commonly used NRTLs:
- Intertek (ETL mark): an international testing and certification group whose history goes back to Thomas Edison’s electrical testing laboratory. The ETL mark is widely accepted in North America across household appliances, IT equipment and many other sectors, and Intertek is known for fast turnaround and flexible service.
- CSA Group: the Canadian Standards Association leads standards development and certification in Canada and is also recognised by OSHA as an NRTL. A “CSA us” mark shows compliance with US safety standards; with the “c” and “us” indicators, a product shows compliance with both Canadian and US requirements.
- TÜV (e.g. TÜV Rheinland, TÜV SÜD): German testing organisations whose US entities are recognised NRTLs. TÜV is known for its rigour and is well recognised for industrial machinery, automotive components and medical equipment, combining German engineering thoroughness with North American compliance – attractive for companies addressing both the North American and European markets.
- SGS: a global inspection, testing and certification group headquartered in Switzerland whose North American laboratory is an NRTL. Its strength is the global network and the ability to cover safety, EMC and radio testing together.
Other recognised NRTLs include Nemko, QPS, FM Approvals, Element and LabTest. For OSHA, the recognition of all these bodies is equivalent. Manufacturers can choose a partner based on product category, target market, time and cost – what matters is that the final product carries the mark of an NRTL recognised for the relevant standard.
How EVERBIZ can help
US compliance for IVD instruments is complex: besides FDA requirements, safety and EMC certifications must also be addressed. EVERBIZ offers end-to-end support:
- Regulatory consulting: identifying the applicable US safety standards and certification categories and drawing up a compliance roadmap – for example, whether UL 61010-1 or UL 60601-1 applies, or whether special requirements such as hazardous-location certification are relevant.
- Test coordination: if a product fails initial testing, our engineers advise on corrective measures such as insulation design, component selection and construction changes until it complies; similar support is available for EMC testing such as FCC.
- Documentation and factory inspection support: NRTL certification includes factory inspections and technical documentation. We help prepare schematics, critical component lists and user manuals, and prepare you for the factory inspection so that it is passed first time.
Plan NRTL certification early so it does not become the last-minute obstacle to your US launch. Contact us.
This article is for general information only and does not constitute legal advice.