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Dentallabnetwork.com
Outsourcing Concerns- FDA Regulations-ADA Regulati
List of FDA approved custom milled ti abutment blank/mill combo
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<blockquote data-quote="ChrisBWJ" data-source="post: 320156" data-attributes="member: 3124"><p>A little late to the thread here.. What Tim and maybe others have said about the FDA not regulating the practice of medicine is 100% correct.</p><p></p><p>Now if a doctor "brands" their medical device such as "Dr. X Dental Implant Abutments", then the FDA has jurisdiction because the device is being marketed to the public. There are publicly viewable warning letters on the FDA website when doctors brand their product, advertise their device on websites, infomercials, webinars, etc... </p><p></p><p>If Dr. X mills abutments and sends them to their colleague across town, the FDA would consider that marketing as well and Dr. X would be subject to FDA registration, QMS, etc...</p><p></p><p>If Dr. X mills an abutment for a Dr. X's patient without branding or marketing, the FDA considers it "off-label" use of a medical device and the Doctor bears personal responsibility for determining it's use as an appropriate medical device.</p><p></p><p>If a doctor or lab buys and uses (following the manufacturer's Instructions for Use document) a closed milling system which has a 510k clearance. The doctor nor the lab are required to register with the FDA or implement a formal QMS. The doctor or lab cannot re-brand the abutments and call them something other than the cleared name, otherwise they would be considered a re-labeler in the FDA's eyes and registration/QMS become necessary.</p></blockquote><p></p>
[QUOTE="ChrisBWJ, post: 320156, member: 3124"] A little late to the thread here.. What Tim and maybe others have said about the FDA not regulating the practice of medicine is 100% correct. Now if a doctor "brands" their medical device such as "Dr. X Dental Implant Abutments", then the FDA has jurisdiction because the device is being marketed to the public. There are publicly viewable warning letters on the FDA website when doctors brand their product, advertise their device on websites, infomercials, webinars, etc... If Dr. X mills abutments and sends them to their colleague across town, the FDA would consider that marketing as well and Dr. X would be subject to FDA registration, QMS, etc... If Dr. X mills an abutment for a Dr. X's patient without branding or marketing, the FDA considers it "off-label" use of a medical device and the Doctor bears personal responsibility for determining it's use as an appropriate medical device. If a doctor or lab buys and uses (following the manufacturer's Instructions for Use document) a closed milling system which has a 510k clearance. The doctor nor the lab are required to register with the FDA or implement a formal QMS. The doctor or lab cannot re-brand the abutments and call them something other than the cleared name, otherwise they would be considered a re-labeler in the FDA's eyes and registration/QMS become necessary. [/QUOTE]
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Outsourcing Concerns- FDA Regulations-ADA Regulati
List of FDA approved custom milled ti abutment blank/mill combo
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