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.
Recent Updates
- DOJ, HHS Announce One-Stop Shop for Companies Voluntarily Disclosing Potential Health Care Fraud
- DOJ, HHS, CMS Launch an FCA Self-Disclosure Program for Health Care: Who Can Participate, How, and Why
- Psychedelics Move Toward the Mainstream: Lawyers’ Bird’s-Eye View from the Horizons Conference
- CMS Receives Its Exclusion Authority: What Happens Now?
- GLOBE Model Final Rule Drops — but Will It Work on a Smaller Scale?