Many myths surround the term 'medical device adhesive', including myths about FDA approval, and myths that an FDA device master file on an adhesive denotes or implies bio-compatibility.
As well as FDA approval, the other types of approval commonly requested in the medical device manufacturing industry include USP Class VI and ISO10993, which cover areas such as cytotoxicity testing of bonded components.
Simply put, medical device adhesives are 'adhesives that are marketed to medical device manufacturers'. Unlike food grade adhesives, these adhesives contain no special approval or blessing from the FDA. Often, bio-compatibility testing is performed on the adhesive as a marketing tool to increase the buyer's trust in the product. Even then, the testing does not replace the testing required of the device manufacturer by the FDA. Manufacturers are required to prove that the device they manufacture is bio-compatible and effective.
We know that '"adhesives that are marketed to medical device manufacturers"' doesn't give you an overload of information. But it does drive home the point that they are not sanctioned by any governing authority. So, what are they? ...Generally, the term 'medical device adhesives' refers to those adhesives used on devices that come into contact with the body, body fluids or delivery systems. As such, the adhesives are designed to bond the plastics and other materials common to the industry. So a UV curable adhesive used to bond an oxygen mask together is likely considered a medical device adhesive, but the epoxy, threadlockers and, structural acrylics used in the manufacture of an x-ray machine are not. However, if you use the same epoxy used in the x-ray machine to bond a needle into the hub of a hypodermic needle...well, now there is a medical device adhesive!