Use Case 5: Consolidated registry of marketed medical devices
From Demand-Driven Open Data for HHS
Use case summary
- Title: Consolidated registry of marketed medical devices
- Work item: https://github.com/demand-driven-open-data/ddod-intake/issues/5
- Status: Closed. The openFDA API now includes device registration and device listing information: https://open.fda.gov/device/registrationlisting/. For more information, see the Solution section.
- Find ways to consolidate multiple data sources (MDR, PMA, 510(k), R&L) in order to build a list of all marketed medical devices
- Currently this is possible only via FOIA requests. There have already been multiple requests for this data at regular refresh intervals.
- Value to customer: Needed for core services on medical device insights provided to hospitals
- Value to industry/public: Important to take cost out of the system. Hospitals struggle to understand available substitutes for a given device Similar to role as Orange Book in pharma.
- Procured Health: Provides outcomes-driven device acquisition and management to hospitals
Current data and limitation
- Data source: PMA, 510(k), R&L (Registration and Listing datasets)
- A single marketed product often has multiple 510(k)s
- A PMA might represent multiple marketed products over the course of the evolution of the device
- 510(k) and PMA downloads only include class II and III devices, omitting class I
- FDA already has an internal database (that can be queried via FOIA request) of "registered devices" that de-dupes all data sources and includes class I devices. Provide either:
- Download files in CVS format, refreshed monthly
- API, perhaps via OpenFDA
- All identifying fields: FEI, UDI, 510(k) #, PMA #
- Ideally provide UDI as soon as it's available, since it will help hospitals cross-ref devices much more accurately
- own_op_num (FK to the owner/operator file)
- submission_nbr (filing num)
- product_code (3 digit code -- see the FDA’s product code download)
- prop_name (product name)
MonthlyFDA is willing to commit to weekly updates
Long Term Implementation
Solution #1: API via openFDA.gov
- Access method: API via openFDA.gov (released as of September 2015)
- API website: https://open.fda.gov/device/registrationlisting/
- API field reference: https://open.fda.gov/device/registrationlisting/reference/
- Field sections include:
- US agent
- proprietary names
- establishment types
- Includes class I devices and both 510(k) and PMA devices
- Registration and Listing API joins to 510(k) API on "k_number" and to PMA API on "pma_number"
- Field sections include:
- FDA Blog which includes background info about data sources and API limitations, which should assist in interpreting the added data: http://blogs.fda.gov/fdavoice/index.php/2015/09/openfda-makes-medical-device-related-data-easier-to-access-and-use/
- Data source: System of record is Device Registration and Listing Module (DRLM), which is part of the FDA Unified Registration and Listing System (FURLS)
Solution #2: Website with R&L query
- Access method: web access with search capability and text file download (Similar to existing R&L access)
- Target release date:
- Occurring in parallel with Solution #1
- Dependency: Comment period on the draft guidance for “Transfer of a Premarket Notification (510(k)) Clearance” is over and the final guidance issued
- Fields: Will include 510(k) and PMA numbers
- Other potential fields being evaluated for inclusion: spreadsheet of API fields being considered for release
- "...UDI won't be included at this point as there is not yet much data in the GUDID database and it is not yet validated or cross-referenced with other databases at the center. We will continue to evaluate the GUDID database and we look forward to being able to integrate the UDI number."
- Include owners of 510(k)s and PMAs
- Exclude PMA or 510(k) contract manufacturers and sterilizers or foreign private label distributors, because that information is considered company confidential and non-releasable data per 21 CFR 807.37.
- It will include Class I devices
Short Term Workaround
- Be specific in FOIA requests, including fields requested, format, time range
- See list of all available fields on Medical Device Registration and Listing website or spreadsheet of API fields being considered for release
- Note that company confidential fields may be withheld due to regulatory constraints. For example: contract manufacturer, sterilizer and foreign private label distributors.
- Ask specifically for the CDRH/OC/DAPO/RRB branch to execute the requests and that it be pulled from the DRLM database
- DRLM (Device Registration and Listing Module) is the consolidated system of record. It's part of the FDA Unified Registration and Listing System (FURLS) and is administered by the Division of Analysis and Program Operations.
- For maximum consistency, consider asking for the same individual to run the query as last time
- Obtain Class I devices via downloads at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm134495.htm.
- Get involved in pre-release testing of the upcoming releases to openFDA and R&L described in the Long Term Solution below