Well, I was already questionning whether our product is a medical device (accessory) conform the FDA.
Conform the European Medical Device Directive (MDD) and the Medical Device Regulation (MDR) our product is a medical device (more specific an accessory of a medical device).
Article 2 paragraph 2 MDR: ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).
Our product is intended to be used together with several medical devices (reusable surgical instruments and/or implants) to specifically enable the medical device(s) to be used in accordance with its/their intended purposes (reuse/ reprocessing). As mentioned, part of the intended use of these reusable surgical instruments and/or implants is the reuse/reprocessing, which our product is facilitating. Perhaps I have not described it clearly enough here, but we do meet this requirement.
Now, one of our customers is planning to distribute our product in the U.S. According this customer, our product is a medical device (accessory). Therefore, we started to review the U.S. regulations. While doing this, we were confused. We do not consider our product as an accessory (device) conform Section 201(h) of the FD&C Act.
Recently, this customer told us they have determined our product as a FDA device by U.S. regulation 878.4800 (Manual surgical instrument for general use). This section 878.4800 sub (a) identifies a manual surgical instrument for general use intended to be used in various general surgical procedures as a“Manual surgical instrument for general use”.
However, we do not consider our product as a surgical instrument. Our product is intended to facilitate the reprocessing of the surgical instruments in our product, to protect the surgical instruments in our product against damage that can occur during reprocessing, transport and storage within the health institution and to promote a clear overview of the surgical instruments in our product. The product is not intended for human use and does not deliver any performances during surgical procedures.
The Medical Device Regulation (EU) 2017/745 (MDR) has defined “(reusable) surgical instruments” as: “instruments intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilization have been carried out.” (Annex VIII, Chapter 1, 2.3), which clarifies that our product is not a surgical instrument (it is not intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures).
We already asked this customer for explanation, while waiting, I was hoping the definition of "human use" would give me more insight. However, we come across the same question: whether our product is a device/ accessory conform the FDA? I patiently await our customer's answer (they have more recources). Perhaps the FDA uses another definition for (reusable) "surgical instruments" than the MDR?
