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) Standardized date reflects global economy

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

Sponsored Post

With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?

Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.

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.

presented by

Sponsored Post

A Personalized Approach to Medication Nonadherence

At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.

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.