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# MDMA’s Concerns on FDA UDI Information Collection
- URL: https://www.fdaweb.com/mdmas-concerns-on-fda-udi-information-collection/
- Published: 2016-12-12T12:00:00.000Z
- Updated: 2026-09-14T21:53:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137541

The Medical Device Manufacturers Association (MDMA) says it is concerned about an FDA estimate that there are no capital costs or operating and maintenance costs associated with the agency’s proposed collection of information on the unique device identification system. “This is concerning as this assumption suggests that medical device manufacturers have not had to invest in any initial or ongoing capital costs or operating or maintenance costs over the life of the device,” the association’s comment [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-D-1853-0024&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) says. “Contrary to FDA’s assumptions, medical device manufacturers have had to invest in bar coding application and reader systems, software database systems to maintain and track data as well as upgrade current systems (e.g. complaint handling and device service record system) to incorporate UDI data to satisfy conforming amendments of the UDI rule. These investments have cost medical device manufacturers millions of dollars with continual operating and maintenance costs to maintain UDI data.”

The letter also includes specific recommendations for changes in the guidance.