Regulation of Medical Devices in the United States and European Union

[AnaMariaVR2]

The New England Journal of Medicine article

Regulation of Medical Devices in the United States and European Union

Daniel B. Kramer, M.D., Shuai Xu, M.Sc., and Aaron S. Kesselheim, M.D., J.D., M.P.H.
N Engl J Med 2012; 366:848-855March 1, 2012

http://www.nejm.org/doi/full/10.1056/NEJMhle1113918

[pkost]

Interesting article - certainly one of the more accurate ones written by medical professionals. Shame it didn't really say anything new.

[lfrost]

I agree with the article being interesting, however, it only addresses medical devices that in the US are classified as Class III. Class II devices are also ones that must be proven to be safe and effective by the manufacturer albeit that all class II devices do not need to be put through PMA by the US FDA. This becomes very confusing for manufacturers who will just distribute their devices without registering their devices with the US FDA. A simple process really, when compared to the alternative.

[AnaMariaVR2]

FDA Device Registration and Listing
http://www.fda.gov/medicaldevices/de...ng/default.htm

FDA Access Electronic Registration
http://www.fda.gov/MedicalDevices/De.../ucm053156.htm

Med. Dev. Search Registration and Listing
http://www.fda.gov/MedicalDevices/De.../ucm053199.htm

[Ronen E]

In Reply to Parent Post by lfrost

I agree with the article being interesting, however, it only addresses medical devices that in the US are classified as Class III. Class II devices are also ones that must be proven to be safe and effective by the manufacturer albeit that all class II devices do not need to be put through PMA by the US FDA. This becomes very confusing for manufacturers who will just distribute their devices without registering their devices with the US FDA. A simple process really, when compared to the alternative.

Sorry if it sounds petty, but actually Class II devices are not directly required "to be proven to be safe and effective by the manufacturer". They are required (except those that are 510k exempt) to be "substantially equivalent" with a legally marketed device (such equivalence may be substantiated, for instance, by showing that the intended use and the technological characteristics are the same). Indeed, in many cases such equivalence would presumably indicate safety and effectiveness.

[lfrost]

In Reply to Parent Post by Ronen E

Sorry if it sounds petty, but actually Class II devices are not directly required "to be proven to be safe and effective by the manufacturer". They are required (except those that are 510k exempt) to be "substantially equivalent" with a legally marketed device (such equivalence may be substantiated, for instance, by showing that the intended use and the technological characteristics are the same). Indeed, in many cases such equivalence would presumably indicate safety and effectiveness.

RonenE,

You are correct, thank you for setting me straight on something that I knew, but left out of my reply.