| Many myths surround the term 'medical device | | | | information which the FDA may require that a |
| adhesive', including myths about FDA approval, and | | | | manufacturer of components of medical devices is |
| myths that an FDA device master file on an adhesive | | | | unwilling to provide directly to the manufacturer. |
| denotes or implies bio-compatibility. | | | | Having a file number does not even indicate that the |
| As well as FDA approval, the other types of approval | | | | FDA has read the contents, no less made a decision |
| commonly requested in the medical device | | | | on them. |
| manufacturing industry include USP Class VI and | | | | So if medical device adhesives are not FDA |
| ISO10993, which cover areas such as cytotoxicity | | | | approved, what are they? |
| testing of bonded components. | | | | We know that '"adhesives that are marketed to |
| Simply put, medical device adhesives are 'adhesives | | | | medical device manufacturers"' doesn't give you an |
| that are marketed to medical device manufacturers'. | | | | overload of information. But it does drive home the |
| Unlike food grade adhesives, these adhesives contain | | | | point that they are not sanctioned by any governing |
| no special approval or blessing from the FDA. Often, | | | | authority. So, what are they? ...Generally, the term |
| bio-compatibility testing is performed on the adhesive | | | | 'medical device adhesives' refers to those adhesives |
| as a marketing tool to increase the buyer's trust in | | | | used on devices that come into contact with the |
| the product. Even then, the testing does not replace | | | | body, body fluids or delivery systems. As such, the |
| the testing required of the device manufacturer by | | | | adhesives are designed to bond the plastics and |
| the FDA. Manufacturers are required to prove that | | | | other materials common to the industry. So a UV |
| the device they manufacture is bio-compatible and | | | | curable adhesive used to bond an oxygen mask |
| effective. | | | | together is likely considered a medical device |
| The logic path is this: | | | | adhesive, but the epoxy, threadlockers and, |
| * Adhesives are tested for bio-compatibility after | | | | structural acrylics used in the manufacture of an |
| they are cured; | | | | x-ray machine are not. However, if you use the |
| * Lack of proper curing can affect bio-compatibility; | | | | same epoxy used in the x-ray machine to bond a |
| * Curing occurs within the device manufacturer's | | | | needle into the hub of a hypodermic needle...well, now |
| assembly process. | | | | there is a medical device adhesive! |
| Therefore: | | | | So, choose the adhesive that meets your |
| * Bio-compatibility can only be determined on the | | | | requirements, regardless of whether it is termed a |
| finished device. | | | | medical device adhesive or not. |
| Also FDA master files are a repository for | | | | |