The FDA, as part of the transparency initiative, has developed a Total Product Life Cycle (TPLC) report capability on their website (www.fda.gov). The intention behind this new report is to provide existing data to medical device manufacturers that will enable them to proactively address quality related issues as early as possible. The TPLC database allows users to search by type of device (product code) and provides a report that identifies the related 510(k) clearances for that particular product code, recall reports, and medical device reporting (MDR) information for the product code selected. What does that mean? Ultimately, companies should have quality systems that incorporate TPLC information into all aspects of their system; such as supplier qualification/monitoring, risk management, design controls, corrective and preventive action, and complaint handling. Incorporating this information throughout the entire life cycle of the device will bring devices to market more efficiently and with less issues post-launch.
The database can be found at the following link:
Here are ten tips for improving quality practices by using the TPLC data:
1. Develop strong Regulatory Strategies using TPLC information to research and verify that the Product Code and Regulation classifications for devices are consistent with industry practice. Ensure sound predicate device selection for 510(k) substantial equivalence demonstration; ensure that the right testing is planned and developed to demonstrate that differences between the new device and the predicate device do not pose any new safety or efficacy concerns by reviewing the 510(k) summaries for the product code.
2. Assess potential issues that may arise and feed them into the design input phase of a new or changing device by using Recall and MDR reports which detail specific issues with product in the field. This information allows users to ensure that all potential safety, efficacy and reliability issues are addressed proactively.
3. Calibrate and strengthen non-filing justification documentation for design changes by using the TPLC report to find information regarding known competitor design changes and premarket application position; i.e., did they submit a new 510(k) for a new release…if not, perhaps a letter to file/non-filing justification was completed.
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