FDA Proposes Unique Device Identification Rule
FDA yesterday released a proposed rule requiring medical device manufacturers to include a unique identifier on most of their products in order to reduce errors from misuse and speed recalls of defective products.
Under the proposed unique device identification (UDI) system, the lot or batch number, serial number, expiration or manufacture date, and information about the model and labeler must be marked in both plain text and via a bar code on the label of most medical devices. Most of that information will also be included in a publicly accessible database to be created by FDA.
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*Source: MDDI