8 October, 2013 Maria Fagan, President, Regulatory & Quality Solutions LLC
What does that mean? Ultimately, companies should have quality systems that incorporate TPLC information into all aspects of their systems, 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 fewer issues post-launch.
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.
The database can be found at the following link:
Here are 10 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.
4. Understand potential problems and proactively design quality solutions into the manufacturing process by using the TPLC MDR and Recall reports during manufacturing planning; what has gone wrong at other companies and how can we learn from this?
5. Ensure that all foreseeable issues seen in the field by competitor products via the MDR and Recall data are considered and assessed during all Design Reviews.
6. Design solid Verification and Validation (V&V) and clinical testing plans by using TPLC 510(k) data to understand the testing that was completed for other products as well as the MDRs and Recalls for potential issues that testing may detect. Access to what was tested previously in applicable 510(k)s or what failed in MDRs/Recalls allows users to look for potential foreseeable failures prior to and during bench and usability testing scenario design. Additionally, the 510(k) data will assist in understanding if clinical human studies were previously required in competitor submissions.
7. Proactively investigate similar potential problem areas as seen in the TPLC MDR and Recall reports during internal audits and for management review discussions.
8. Understand the Recall and MDR position of competitors and calibrate on industry practice using the TPLC database. This aspect will provide an understanding of when competitors are issuing MDRs and/or are recalling. Note however that just because your competitors aren’t reporting via MDR on a common issue does not mean or justify that the issue should not be reported. It is simply food for thought as part of the MDR assessment.
9. Plan supplier audits and monitoring tools with the assistance of the TPLC MDR and Recall information to avoid the issues that competitors have had to deal with while their product was in the field.
10. Finally, gain input to management reviews from a post market surveillance study perspective, as well as potential preventive actions and quality system improvements that can proactively be incorporated.
For your convenience…
To access the TPLC Database, go to the FDA website: www.fda.gov
1. Click on the Medical Devices tab at the top of the page
2. In the “Program Areas” box, click on “CDRH Transparency”
3. Scroll down on the left hand side of the page and click on “Total Product Life Cycle”
4. Locate the “Total Product Life Cycle (TPLC) Database” box in the center of the page. Click on “Total Product Life Cycle (TPLC) Database Search”
5. Enter the description of the device and the date, and click on “Search”
Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.
Maria Fagan is President of Regulatory and Quality Solutions, LLC (R&Q). Maria has extensive experience in medical device development across regulatory and quality areas as well as post-surveillance and compliance. In 2008, Maria along with partners Lisa Casavant and Robert Markley founded R&Q to support their entrepreneurial desires to serve the medical device industry with business balanced, hands-on regulatory and quality expertise so as to accelerate the success of medical device companies and thereby improve people’s lives. Maria holds a B.S. in Mechanical Engineering and has worked in the medical device quality and regulatory arena for nearly 20 years.