Jedrzej Kocinski
Assistan Professor (dr hab.) w Uniwersytet im. Adama Mickiewicza w Poznaniu
February 2017
< 1 min reading time
As far as I know it is not obligatory to have one to get 510(k) cleared in FDA. There are no medical devices on OSHA list. However most of the people say that it is necessary in practice, because hospitals and other institutions do not want to use device without NRTL sign. Do you have any experience with that? Which NRTL should we consider? Marked as spam
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G M Butcher
'not obligatory to get 510(k)' - misinformed conclusion -it could be exempt, a PMA, or not a medical device - so in a manner true.
'no medical devices on OSHA list' - true - NRTL is a list of testing companies not devices, and OSHA and FDA have different areas of regulatory responsibility. 'use device without NRTL' - probably - again NRTL is only a list of product safety testing labs, organizations use an NRTL for independent certification of product safety. Product safety is a requirement for many medical devices and OSHA equipment, so not true, misinformed. Medical devices are for patients, OSHA equipment is for occupations (e.g., breathing equipment for minors). Without more complete information, cannot suggest a route. If a medical device is planned it seems your organization needs some outside expertise. Marked as spam
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Julie Omohundro
G M, I decided he meant than an "NRTL sign" wasn't needed in order to get a 510(k) cleared.
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Jedrzej Kocinski
And if the device can be used at home only, but for telemedicine? I mean that a doctor is necessary for consultation, but the device is at home with patient. Do we need any NRTL mark on it? I know that NRTL mark is not obligatory from the FDA point of view, however what is the practice- I heard that in practice it is hard to get to the market without such a mark like C.UL.US or other, moreover UL is prefered rather than other NRTLs. What I am afraid is that when we get 'FDA cleard' and then nobody would like to sell our device because we do not have NRTL mark on it.
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Aaron Liang
If a hospital does accept a device without NRTL, it will create more headaches for you in terms of selling and market access because your product will constantly have to through biomed for their electrical checks.
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Leonard Eisner
The NRTL program deals with test labs qualifying them as able and capable of testing to specific standards. There are only two medical device standards that are on their list of allowed standards under the NRTL program (Nationally Recognized Test Lab) at OSHA. Those standards are UL 60601-1 (which is based on the 2nd edition of IEC 60601-1) and ANSI/AAMI ES 60601-1 (based on IEC 60601-1, 3rd edition +Amendment 1). OSHA and FDA actually had conversations to align with ES 60601-1. OSHA was never happy with any standard based on IEC 60601-1, 3rd edition so they skipped over it. Most hospital biomeds in the US will not accept a product with out the US NRTL Mark on the product. It is not true that all US hospitals expect the UL NRTL mark and many of my clients avoid going to UL because of cost and other issues. See 2nd post for continuation of this response.
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