FDA publishes final unique device identifier rule for medical devices
The US Food and Drug Administration (FDA) issued the final unique device identifier (UDI) rule on 24 September 2013, following up on the draft rule previously circulated by the FDA on 3 July 2012.
With limited exceptions, the rule requires that medical devices are labelled with a UDI in both a plain-text format and in a format that uses automatic identification and data capture (AIDC) technology, such as a barcode or radio-frequency identification. The UDI must be placed on the medical device labels and packaging and the UDI must include two parts: both a device identifier and a production identifier.
The device identifier corresponds to the version or model of the device, and the production identifier identifies the specific device through means such as the serial number, lot, batch, expiration date or date of manufacture. For a human cell, tissue or cellular and tissue-based product (HCT/P) regulated as a device, the production identifier can include the distinct identification code required for these devices under 21 C.F.R. §1271.290(c)…
If you are registered and logged in to the site, click on the link below to read the rest of the Hogan Lovells briefing. If not, please register or sign in with your details below.
News from Hogan Lovells
Briefings from Hogan Lovells
Those who have had any involvement with Telephone Consumer Protection Act (TCPA) litigation in the last year will be unsurprised to learn that TCPA lawsuits are on the rise.
The UK government supports the European Commission’s decision not to impose mandatory quotas; it favours a self-regulatory national level approach.
Analysis from The Lawyer
When a firm shouts loudly about a landmark merger, as SJ Berwin did when it joined forces with King & Wood Mallesons, departures are always likely to come under the spotlight.
The Lawyer’s latest Top 50 litigation firms list shows that business for dispute specialists is roaring along while new in-depth detail reveals the winning strategies