Use Case 5: Consolidated registry of marketed medical devices

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Requirements

Use case summary

Description

  • 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

  • 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.

Customer

  • 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)
  • Challenges:
    • 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

Specifications

Access method:

  • 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

Fields:

  • 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
  • reg_key
  • 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)
  • pref_name
  • prop_name (product name)
  • description


Update frequency:

  • Monthly FDA is willing to commit to weekly updates


Solution

Long Term Implementation

Solution #1: API via openFDA.gov

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm


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    • Dependency: Comment period on the draft guidance for “Transfer of a Premarket Notification (510(k)) Clearance” is over and the final guidance issued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

FOIA requests

  • Be specific in FOIA requests, including fields requested, format, time range
  • 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

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