Written and maintained by CASRAI Editorial Board
Last updated
General product information only, not medical advice. A custom procedure tray is a set of medical devices packed together for one type of procedure. In US law the term that fits most of them is “convenience kit”: two or more different medical devices packaged together for the convenience of the user (21 CFR 801.3). This page is for the people who specify, buy or receive trays. It covers what the FDA says about trays, the typical tray types it names, and a list of documents worth asking a tray assembler for. It does not describe how any procedure is done.
Purpose and setting: what a custom procedure tray is
A custom procedure tray (also sold as a procedure pack, procedure kit or custom procedure pack) is a tray or pack built to a facility’s own list of components for a named procedure. The preference card that lists a clinician’s items is the usual starting point; see physician preference items and preference cards for how those lists are built. The comparison of pre-assembled procedure kits and building your own covers the make-or-buy choice, and the surgical pack guide covers one common tray family.
The words are used loosely, but FDA’s own convenience-kit guidance treats them as interchangeable: “the terms ‘kit,’ ‘set,’ and ‘tray’ are considered synonymous” (FDA, Convenience Kits Interim Regulatory Guidance, 20 May 1997, checked 2026-11-01). So a “procedure tray”, a “procedure pack” and a “procedure kit” raise the same regulatory questions. The useful distinction is not the name but who assembled it, from which components, and what was done to the finished set.
Checklist table: tray types FDA names, grouped by specialty
FDA’s 1997 guidance attaches a list of generic kit and tray types, organized by medical specialty. The list is a record of kit types FDA had already seen in 510(k) reviews; it is not a recommended contents list, and FDA states the list may be updated. The table below shows a sample of entries from the list, with the specialty headings used there. The guidance names tray types, not component counts, so the quantity of each component is whatever the facility’s own list for that procedure says.
| Specialty heading on FDA’s list | Example tray or kit names on the list | What it tells a buyer |
|---|---|---|
| Anesthesiology devices | Custom Anesthesia Tray; Nerve Block Tray; Spinal Anesthesia Kit | “Custom” trays appear on the list by name, so a custom tray can still be a recognised kit type. |
| Cardiovascular devices | Cardiovascular Surgical Instruments Tray; Central Venous Catheter Tray; CT Biopsy Tray | Instrument trays and catheter trays are listed as separate kit types. |
| Dental devices | General Purpose Dental Tray; Oral Surgery Tray; Dental Implant Surgical Tray | See the dental tray guide for the reprocessing side. |
| Ear, nose and throat devices | Ear, Nose, and Throat Surgical Tray; Tracheostomy Cleaning Tray | The same list covers both procedural and cleaning or care trays. |
| Gastroenterology-urology devices | Bulb Irrigation Tray; Catheter Care Tray; Hemodialysis Tray | Irrigation, care and dialysis trays each have their own listed type. |
Documents to request from a tray assembler
The second table turns FDA’s stated expectations into questions a purchaser can put to a supplier. Each row is phrased as something to ask whether the assembler has; none of it is a legal requirement beyond what the cited sources say.
| Item to ask for | Quantity | Why (source) | Notes |
|---|---|---|---|
| Full component list with each component’s marketing status | One list per tray design | The 1997 guidance applies where components are legally marketed pre-amendments devices, exempt from premarket notification, or found substantially equivalent through 510(k), and are bought in finished form. | Ask whether any component was relabeled or altered. |
| Statement that the tray matches a kit type FDA lists, or a 510(k) number for the kit | One per tray design | Enforcement discretion in the 1997 guidance covers “convenience kits of a type matching one of those included on the attached list”. | A tray outside the list is not automatically covered. |
| Sterilization and processing statement | One per tray design and process | The guidance says the assembler must consider the effect of any processing on the components, and that terminal sterilization of the kit and its components has been a focus of review. | Ask which method is used and how component sensitivity was assessed. |
| Registration and listing information for the assembler | Once per assembler | Assemblers remain subject to general controls including registration, listing, the misbranding prohibition and good manufacturing practices (1997 guidance). | Ask for the assembler’s establishment details. |
| Labeling and UDI on the tray label | One per tray design | Individual devices inside a convenience kit’s immediate container are excepted from UDI labeling if the kit’s immediate container label bears a UDI (21 CFR 801.30(a)(11), as described in the 26 April 2019 Federal Register notice). | See UDI labels for what a UDI contains. |
| Substitution and change-notification terms | Written once, reviewed on change | FDA reads “convenience kit” as devices intended to remain packaged together and not be replaced, substituted or repackaged (2019 UDI guidance). | Ask how a changed or discontinued component is communicated before the tray ships. |
| Drug components, if any | Per component | The 1997 guidance says drug components in a kit are handled separately from the device policy. | Ask whether any component is regulated as a drug. |
What varies by facility type
The clearest variation in the sources is by clinical specialty rather than by building: FDA’s list is organized by specialty, and a dental practice, an anesthesia service and a dialysis unit appear under different headings with different tray types. Within a specialty, the contents follow the facility’s own procedure list and preference cards. How a facility keeps those cards current and ties them to carts is covered in the case cart guide.
Storage, expiry and restocking
FDA’s 1997 guidance observes that kit labeling tends to identify the assembler and the kit’s intended use. Storage conditions and any dating on a tray come from that tray’s label and the instructions for use that accompany its components, so the label and the components’ instructions are the reference, not a general rule of thumb. When a tray is opened and part of it is not used, the facility’s own policy governs what happens next. The rule that matters at receiving is that a tray is a single labeled device: if a supplier proposes swapping a component, that is a change to the tray, which is why the change-notification question appears in the table above.
Standards and rules that apply
- 21 CFR 801.3 defines “convenience kit” as two or more different medical devices packaged together for the convenience of the user (eCFR, checked 2026-11-01).
- FDA, Convenience Kits Interim Regulatory Guidance, 20 May 1997. FDA intends to exercise enforcement discretion on premarket notification for kits of a listed type, made of cleared or exempt components, where the assembler can reasonably conclude that further processing does not significantly affect safety or effectiveness. Supporting documentation is to be kept under the Quality System regulation (21 CFR 820).
- FDA, Unique Device Identification: Convenience Kits guidance, April 2019 (Federal Register notice of 26 April 2019). FDA says it does not consider every medical procedure kit, nor every collection of two or more devices, to be a “convenience kit” for UDI purposes; a labeler may request an exception or alternative under 21 CFR 801.55.
These are FDA statements for the United States. Guidance documents represent FDA’s current thinking and do not bind the public.
FAQ
What is a custom procedure tray?
It is a set of medical devices packaged together for a particular procedure, built to a facility’s own component list. In FDA terms it is usually a convenience kit (21 CFR 801.3).
Is a procedure pack the same as a procedure kit or a custom tray?
For regulatory purposes the names do not change the analysis: FDA’s 1997 guidance treats “kit,” “set” and “tray” as synonymous. Whether the product counts as a convenience kit for UDI purposes depends on whether it holds two or more different devices meant to stay packaged together.
Does every procedure kit count as a convenience kit?
No. In its 2019 UDI guidance FDA states that it does not consider every medical procedure kit to be a convenience kit for purposes of the UDI regulations.
What should a buyer ask a tray supplier for?
The component list with marketing status, the kit type or 510(k) basis, the sterilization and processing statement, registration and listing details, the label and UDI, and the terms for changing a component. The table above gives the source for each.
Sources
- eCFR, 21 CFR 801.3, definitions, checked 2026-11-01: ecfr.gov, section 801.3.
- FDA, Convenience Kits Interim Regulatory Guidance, 20 May 1997, checked 2026-11-01: fda.gov.
- FDA, Unique Device Identification: Convenience Kits, guidance of April 2019, and the Federal Register notice of 26 April 2019 (2019-08472), checked 2026-11-01: fda.gov; govinfo.gov.
