To add to what Lee said,
The Convenience Kit Guidance is here:
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdfSince some of the devices hold 510(k)s you may need to submit a 510(k) that includes the following statement:
"
I certify that the following components of my kit are either (1) legally marketed pre-Amendments devices, (2) exempt from premarket notification (consistent with the exemption criteria described in the classification regulation(s) and the limitation of exemptions for Section 510(k) of the act (e.g., 862.9), or (3) have been found to be substantially equivalent through the premarket notification process for the use(s) for which the kit is to be intended (i.e., I am not claiming or causing a new use for the component(s)).
I further certify that these components are not purchased in "bulk", but are purchased in finished form, i.e., they are packaged, labeled, etc., consistent with their pre-Amendments, exemption, or premarket notification criteria and status." https://www.fda.gov/RegulatoryInformation/Guidances/ucm080213.htm
This guidance may also help you:
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071029.pdf
Like Lee said, without more details it's a tough questions to answer.
------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States
------------------------------
Original Message:
Sent: 26-Apr-2017 14:07
From: Anonymous Member
Subject: New Convenience Kit
This message was posted by a user wishing to remain anonymous
The products will be obtaining directly from the manufacturer and some of them individually hold 510k.
The activity my company want to performs is to manufacture/repackage of all the product together as a convenience kit.
- What regulation applied to combine the following products in a kit of convenience?
- As a kit a new 510k will be required if some of them individually hold a 510k?
| Quantity | Description |
| 1 | Sterile Separate Echogenic 19GA x 7CM Needle |
| 1 | Non-absorbable, Surgical Suture |
| 1 | Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port |
| 1 | 5 Fr. Catheter Clamp with Fastener |
| 1 | Saline Flush (5cc Pre-filled Syringe) |
| 1 | 10cc Syringe |
| 1 | Thumb Scalpel |
| 1 | Insert |
| 1 | Pouch |
| 1 | UDI Label |