Do I need to have UL or TUV or other mark to sell device in USA

M

maple68

#1
Dear all,

I'm new to this forum. But I have learned a lot from here. Much appreciated.

Our product is class IIa and was CE marked. We are planning to get FDA approval soon.

We were told we need to have UL or TUV mark. I'm not sure if this is mandatory or nice to have, especially considering the expense.

Can anybody help me?

Thanks a lot!
 
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somashekar

Staff member
Super Moderator
#2
Re: Do I need to have UL or TUV or other mark to sell device in FDA

The mark is not mandatory.
But, to be in competation and to satisfy the healthcare industry and insurance requirements, these marks make a mark.
There is an expense for the first time and the recurring quarterly expense towards payments for follow-up inspections.
 
M

maple68

#4
Thanks a lot! This is very helpful. Then I have another questions.
Is UL the most acceptable mark in USA? If we only choose one, should we go for UL or TUV?

Thanks again,
 

somashekar

Staff member
Super Moderator
#5
Thanks a lot! This is very helpful. Then I have another questions.
Is UL the most acceptable mark in USA? If we only choose one, should we go for UL or TUV?

Thanks again,
That is your decision. Perhaps UL is more recognized in the USA, and I have good experience working with UL.
 
M

MIREGMGR

#6
I'll assume your product is electrically powered. Third party certifications are available and relevant in other contexts, but electrical conformance is by far the most common.

There are two ways that a third party certification can be important:

1. The FDA as a part of the pre market clearance process...510(k) or PMA...may require evidence that your device conforms to relevant standards. For devices that use electrical power, the FDA usually considers IEC 60601-1 relevant, and other standards may be applicable as well. One way to efficiently show the FDA that you have such conformance is to have certification from a third party lab.

2. When you market your device, particularly if you sell directly to hospitals, you may find that buyer-expectations for certification are important. Hospitals often have biomedical engineering personnel, architects, risk managers, legal staff and others who impose purchase specifications to control liability exposure and to conform to Joint Commission and regulatory expectations. In such a marketing context, a third party certification...traditionally called Listing or Labeling, and indicated with a brand mark or label on the device near its electrical connection point...can be important.

This consideration is elevated significantly when a device is permanently wired to the electrical supply, rather than being cord-and-plug connected. In many US jurisdictions, the local electrical code enforcement authority will not permit installation of equipment that is not Listed or Labeled. That stance is consistent with the most commonly used electrical construction/installation codes in the US.

Note by the way that UL is the oldest, but by no means the only, Nationally Recognized Test Laboratory (NRTL). In the US, the Occupational Safety and Health Adminstration (OSHA) supervises the NRTL program. Local electrical code enforcers should accept a certification from any authorized-within-scope NRTL on an equal footing. A list of all the NRTLs is available at the OSHA site.
 
A

Al Dyer

#9
maple68,

Surely not a technical response but many consumers in the US do look for the "UL Approved" mark on the products they purchase. Through an ingrained thought process "most" know to look for the "UL" Rating. We used to get television commercial notices about it. Like said, surely not technical.

Al...
 
N

NickM

#10
There has long been a debate about whether NRTL 3rd party certification is required in the US. The bottom line is this - between customer requirements (i.e., contracts), local adoption/enforcement of the NEC (NFPA 70) & OSHA (29CFR1910 subpart S) & the US legal liability system; one would be very foolish not to have their products certified by an NRTL.

By the way, here is a list of NRTL's that are accredited to certify to UL 60601-1 in the US:
  • Canadian Standards Association (CSA)
  • Curtis-Straus LLC (CSL)
  • Intertek Testing Services NA, Inc. (ITSNA)
  • MET Laboratories, Inc. (MET)
  • National Technical Systems, Inc. (NTS)
  • QPS Evaluation Services Inc. (QPS)
  • SGS U.S. Testing Company, Inc. (SGSUS)
  • TÜV SÜD America, Inc. (TUVAM)
  • TÜV SÜD Product Services GmbH (TUVPSG)
  • TUV Rheinland of North America, Inc. (TUV)
  • Underwriters Laboratories Inc. (UL)
 
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