Regulatory Open Forum

We recently had our first 510(k) cleared by FDA and plan on marketing the device in Q2 2017.

I have two questions regarding the DI for our device:

1) Our product is a single-use, non-sterile, class 2, accessory for an endoscope. The device is packaged in a Tyvek sealed tray that has the product label on it. The device in the sealed tray and an IFU is slipped into a light-weight company branded “shelf box”. The shelf box has a top label with the same information as the Tyvek tray label. The shelf box also has a long-side and short-side label that contains the catalogue number, use by date and lot number (for ease of identification while stocked on a shelf). This PI information along with the DI information will be barcoded on each label (4 labels total). Our base package quantity is one.

Should the sealed tray and the shelf box have the same Primary DI? The shelf box contains only one tray and not multiple trays.

The sealed tray and the shelf box get the same DI. This is not a Unit of Use case since the base package quantity is one. This is not a packaging configuration, since the quantity is one. (A, so called, one-in-a-one, is not a packaging configuration.)

The one piece box and the five piece box are not shipping containers under the UDI rule, because that have a fixed quantity. A shipping container has a variable quantity. Imagine you receive a PO with multiple lines for different items and different quantities. When you fulfil the order, you put it all into a shipping container. The next shipping container has different stuff in it.

Your one piece is not a packaging configuration, since it is a one-in-a-one.

Your five piece is a packaging configuration, since it contains a fixed quantity of the same device. It requires its own DI.

We recently had our first 510(k) cleared by FDA and plan on marketing the device in Q2 2017.

I have two questions regarding the DI for our device:

1) Our product is a single-use, non-sterile, class 2, accessory for an endoscope. The device is packaged in a Tyvek sealed tray that has the product label on it. The device in the sealed tray and an IFU is slipped into a light-weight company branded “shelf box”. The shelf box has a top label with the same information as the Tyvek tray label. The shelf box also has a long-side and short-side label that contains the catalogue number, use by date and lot number (for ease of identification while stocked on a shelf). This PI information along with the DI information will be barcoded on each label (4 labels total). Our base package quantity is one.

Should the sealed tray and the shelf box have the same Primary DI? The shelf box contains only one tray and not multiple trays.