Final Guidance on Custom Medical Devices issued by FDA

A new final guidance document has been released by US FDA for the manufacturers of “custom” medical devices which are defined as devices not being generally available, not available in finished form, deviated for the needs of a specific patient, not advertised for commercial distribution and intended for a specific patient.

While the final guidance is similar to January 2014 draft guidance only certain changes have been made to incorporate the comments received by FDA.A section has been added which states that while examining a custom device FDA will take into account the following parameters which is related to its five unit definition- anatomical location, disease state, material, technology and indications.

The guidance contains a new section which states what need to be done if a patient has to undergo revision surgery to replace a component that is no longer manufactured. According to the new guidance FDA has to be informed by the companies whenever a device will be destroyed by the ordering physician. This does not include those residual devices manufactured for a particular patient which are either returned to the manufacturer or destroyed