The motivation for this month’s post was my frustration with the techniques for searching the FDA’s 510(k) database. Here I’m not talking about just using the search feature that FDA provides online. Instead, I have downloaded all of the data from that database and created my own search engine, but there are still inherent limitations in what the data contain and how they are structured. For one, if you want to submit a premarket notification for an over-the-counter product, it really isn’t easy to find predicates that are specifically cleared for over-the-counter without a lot of manual work.
To see if I could find an easier way, I decided to use the database FDA maintains for unique device identifiers, called the Global Unique Device Identification Database (GUDID). You can search that database using the so-called AccessGUDID through an FDA link that takes you to the NIH where the database is stored. That site only allows for pretty simple search, so for what I needed to do, I downloaded the entire database so I could work directly on the data myself.
While the UDI database is enormous at this juncture (over 3 million products), what I found left me with questions about just how comprehensive and complete the data are. At the same time, it seems like a good way to supplement the information that can be gleaned from the 510(k) database.
Blog Editors
Recent Updates
- Telehealth Cliff Averted, for Now (but September Is Six Months Away)
- The End of the Self-Affirmed GRAS Pathway?
- DEA Telemedicine Rules Further Delayed Until (Nearly) 2026
- Gender-Affirming Care Protections Eroded by Recent HHS Guidance and White House Executive Orders
- Important Negotiating Points in Commercial Real Estate Purchase and Sale Contracts Negotiating the Letter of Intent