(5) A custom device within the meaning of
(6) An investigational device within the meaning of part 812 of this chapter.
(7) A veterinary medical device not intended for use in the diagnosis of disease or other conditions in man, in the cure, mitigation, treatment, or prevention of disease in man, or intended to affect the structure or any function of the body of man.
(8) A device intended for export from
(9) A device held by the Strategic National Stockpile and granted an exception or alternative under
(10) A device for which
(11) A device packaged within the immediate container of a combination product or convenience kit, provided that the label of the combination product or convenience kit bears a UDI.
(b) National Drug Code (NDC) Numbers. If a combination product properly bears an NDC number on its label--
(1) The combination product is not subject to the requirements of
(2) A device constituent of such a combination product whose components are physically, chemically, or otherwise combined or mixed and produced as a single entity as described by
(3) Each device constituent of such a combination product, other than one described by
(c) Exception for shipping containers. This rule does not require a UDI to be placed on any shipping container.
(d) The UDI of a class I device is not required to include a production identifier.
(a) The labeler of a device that is not required to bear a unique device identifier (UDI) may voluntarily comply with
(b) A device may bear both a Universal Product Code (UPC) and a UDI on its label and packages.
(a) Every unique device identifier (UDI) must meet the technical requirements of
(1) Easily readable plain-text, and
(2) Automatic identification and data capture (AIDC) technology.
(b) The UDI must include a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by
Most Popular Stories
- Bipartisan Budget Deal Gets Key Support in House
- TFA Recruiting DACA Recipients
- Bitcoin Clones Lurch Onto Financial Scene
- Clinton to Keynote Annual Simmons Leadership Conference
- Holiday Shopping Off to a Slow Start This Season
- Scotch Whisky Sales Raise Distillers' Spirits
- Podesta Likely to Reject Keystone XL
- Health Coverage Disparities Emerge Among States
- Fake Deaf Interpreter Was Hallucinating, Has Schizophrenia
- Tea Party Glum in Face of Bipartisan Budget Deal