QUESTION ABOUT THE FDA

I received an e-mail from a sharpener last night. He was asking about a shear that was mentioned on one of the online forums. He said it was FDA Registered and was asking if any Wolff shears are registered with the FDA. They are not. He also asked if FDA Registration means the product is approved by the FDA.

To answer the latter part of that question, registration does not mean approval, but that does not mean the product doesn't do what the manufacturer claims it does. As for the the first part of the question, a manufacturer can register with the FDA by filing an "establishment registration” and/or a “medical device listing" with the FDA, which comes with a fee.

If you'd like to find out more about what's involved with registering a devise or product with the FDA, there is a good write up about the ins-and-outs of it on the Inergetix Website. To see the article, click here. In this article they mention that you can search the FDA Establishment Registration and Device Listing Database online to see which companies are registered, here is a link to that site:

http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfRL/rl.cfm

To search the database, just enter the company name in the Establishment Name Box and click search. I searched the company "Ondamed" named in the article I linked to above and found the two registrations the article mentioned. Go to the link above and try it yourself. (Click on the picture if you'd like a larger view)

I hope this answers the question. If any of you ever have any other questions about Wolff products, please drop me an e-mail or give me a call.