Devices & Diagnostics

FDA finally makes final UDI rule: 7 changes medical device manufacturers + physicians should know

The FDA finally made its final unique device identifier rule this week, but the document is thousands of pages long. Jay Crowley, senior adviser of patient safety at the FDA, highlighted seven of the big changes medical device manufacturers should note from last year’s draft to the final. Here they are in laymen’s terms. 1) […]

By Lindsey Alexander on September 20, 2013

The FDA finally made its final unique device identifier rule this week, but the document is thousands of pages long. Jay Crowley, senior adviser of patient safety at the FDA, highlighted seven of the big changes medical device manufacturers should note from last year’s draft to the final. Here they are in laymen’s terms.

1) Standardized date reflects global economy

  • The FDA changed the date to be more Eurocentric: Four-digit year, two-digit month, two-digit day

2) Implants have no direct marking requirements. That’s right–none

  • This was nixed due to cost and complexity. Implants will instead be tracked through the Global UDI Database.

3) Three-year exception for existing inventory

  • Manufacturers concerned about whether to destroy or re-label and repackage existing inventory, worry no more. For any products manufactured and labeled before the compliance date, there’s an exception that allows an additional three years to distribute.
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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

By PurpleLab

4) Only the kit or combination product needs a UDI

  • Components and constituent parts are exempt

5) All single-use devices, regardless of class, can just have a UDI on the packaging/box

  • While Class 1 devices packaged all together–for example, 10 bandages in a box–could just put the UDI on the box rather than each product, now all classes have this exemption.

6) Class 3 devices can ask for a one-year compliance date extension

  • One year from today, Class 3 devices must bear UDIs, unless the manufacturer doesn’t believe it can meet these requirements by the due date. Then they can apply for up to a one-year extension.

7) MRI compatibility must be added to the Global UDI Database, not to the device label

  • Safe, unsafe or conditional–those MRI identifiers should be posted to GUDID, and don’t need to be added to the device itself.