Biomedical Engineering Reference
8.5.5 Regulatory Bodies
Another good source of information is the regulatory bodies themselves. In many cases you
can pull down guidelines that provide pointers to good practice, materials that have been
passed for use in certain areas, materials that are not allowed, and pointers to standards that
may be applicable (although these should have been found in the PDS). An alternative to
this is to ask your supplier if the material has been approved for use by one of the regulatory
bodies - take care though because food use and medical use are not necessarily the same! The
FDA website is, once again, a wonderful resource, if you know your precedents. A simple
510(k) search (as demonstrated previously) reveals a plethora of information related to your
proposed device, as illustrated by the search sequence in Figure 8.5 .
Almost without question is the fact that there will be numerous standards listing what
materials are to be used in certain situations. In fact, it makes sense to make this your first
Using the 510(k) search engine to determine applicable standards for a particular device.