Total Product Life Cycle (TPLC) Data Sources and Disclaimers
The TPLC database combines data from various CDRH databases (data sources) to present an integrated record of premarket and postmarket activity for medical devices.
The TPLC database integrates data by procode, a three-letter code associated with a generic type of medical device. Only datasets containing a procode are included in the TPLC database. Not all of the entries in the data sources have procodes associated with them, so those data are omitted from the TPLC database.
The TPLC reports include counts of the database information (i.e. number of recalls, number of premarket submissions). Details about which events were counted are available through links on the pages. As the various data sources are updated or refreshed, these counts may change.
The TPLC reports provide adverse event information as device problem counts based on MAUDE medical device adverse event reports. The number of reported device problems may not match the number of reports or the number of events, because a report may contain any number of device problem codes and may reference one or more events. In addition, adverse events reported via the Alternative Summary Reporting (ASR) Program prior to the program update in 2017 are not included in the MAUDE or TPLC databases. The ASR program ended in June 2019.
Adverse events from the MAUDE database cannot be used to determine the rate of adverse events for a particular product or to compare adverse event rates between products. Manufacturers submit reports according to their regulatory requirements. Submission of the report does not mean the device caused the adverse event. In most cases, further investigation is necessary to understand the cause of the adverse event.
Additional descriptions and disclaimers are available in the table below for each of the data sources.
TPLC Data Sources
|Premarket Approvals (PMA)||Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database is updated on a monthly basis.||Monthly|
|Premarket Notifications (510(k)s)||Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Some firm names may not be the current 510(k) owner. The Premarket Notification database is not updated when 510(k) ownership transfers from the original sponsor to other firm. The database is updated monthly.||Monthly|
|MAUDE (Manufacturer and User Facility Device Experience)||MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996. MAUDE data is reported by patients, physicians, facilities and the device manufacturers. Preliminary, supplemental and duplicate reports exist.||Monthly|
|Manufacturer Name Consolidation||Applicant/Sponsor/Manufacturer Firm names are not provided with consistent spelling or abbreviations in the MAUDE database. To aggregate the information all firm names have been simplified and consolidated. As data in MAUDE improves, firm names will become the firm name in the registration database.||Monthly|
|Recalls of Medical Devices||This database contains a list of classified medical device recalls since November 1, 2002. Although the recall database is updated frequently as items become available, it is merged with the TPLC data on a monthly basis.||Integrated Monthly|