The United States Department of Health and Human Services (HHS), also known as the Health Department, is a cabinet-level department of the U.S. federal government with the goal of protecting the health of all Americans and providing essential human services. Title: USE_KMCSystems_Total_Product_Life_Cycle Created Date: 8/6/2015 3:17:37 PM The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. We know the regulators. We know the regulators. - Washington, D.C. 20201. 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. Contact us. The .gov means it’s official.Federal government websites often end in .gov or .mil. We know the regulators. The database can be found at the following link: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm199906.htm. Leveraging the technical backgrounds of our lawyers and regulatory science professionals, we provide global premarket assistance for medical devices and in vitro diagnostics. What does that mean? TPLC ; Design & development ; Premarket regulatory strategy ; Distribution ; Postmarket performance ; Compliance & enforcement ; Distribution. 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. Contact us. Total Product Life Cycle. Total Product Life Cycle. 3. Design & developmentWe assist with developing design and development procedures so that you can implement a robust design control process during the entire product life cycle. We know the rules. The official HHS motto is "Improving the health, safety, and well-being of America.". Incorporating this information throughout the entire life cycle of the device will bring devices to market more efficiently and with less issues post-launch. 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. We know the rules. Total Product Life Cycle. We know the regulators. The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTob... A federal government website managed by the U.S. Department of Health & Human Services200 Independence Avenue, S.W. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Partnerships: Enhancing Science Through Collaborations With FDA, The History of FDA's Fight for Consumer Protection and Public Health. TPLC ; Design & development ; Premarket regulatory strategy ; Distribution ; Postmarket performance ; Compliance & enforcement ; Related industries. Or try one of these helpful links to FDA topics: Are you sure this is the right web address? Search FDA.gov Check the FDA Archive Contact FDA. The FDA, as part of the transparency initiative, has developed a Total Product Life Cycle (TPLC) report capability on their website (www.fda.gov). It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. 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. Visit our website at www.rqteam.com/resources to request the full article. Total Product Life Cycle. This information allows users to ensure that all potential safety, efficacy and reliability issues are addressed proactively. Ten Tips for A Successful Use of Total Product Life Cycle (TPLC) Reports, ©2020 REGULATORY AND QUALITY SOLUTIONS LLC (R&Q). Contact us. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. Let us know. We know the rules. 009:005 - Department of Health and Human Services - Devices and Radiological Health, Open Data Commons Open Database License (ODbL), U.S. Department of Health & Human Services. Hogan Lovells has you covered during the total life cycle of a Medical Device. You can search the TPLC database by device name or procode to receive a full report about a particular product line. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The link to this page may not be correct or is out-of-date. Assists in preparing premarket submissions for infusion pumps and to identify device features that should be addressed throughout the total product life cycle. We have been there before. Hogan Lovells has you covered during the total life cycle of a Medical Device. We know the rules. 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. We’re sorry. Contact us. We have been there before. 2. The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. Hogan Lovells has you covered during the total life cycle of a Medical Device. 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. 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 page you are looking for is not available for one of the following reasons. Here are ten tips for improving quality practices by using the TPLC data: 1. 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. We have been there before. The site is secure. We have been there before. TPLC ; Design & development ; Premarket regulatory strategy ; Distribution ; Postmarket performance ; Compliance & enforcement ; Premarket regulatory strategy. Hogan Lovells has you covered during the total life cycle of a Medical Device. You have bookmarked a page that has moved. The information on this page (the dataset metadata) is also available in these formats. The FDA, as part of the transparency initiative, has developed a Total Product Life Cycle (TPLC) report capability on their website (www.fda.gov). Upcoming and on-demand education, commentary from thought leaders, Q&A features, and more. Life Sciences and Health Care. Before sharing sensitive information, make sure you're on a federal government site. You can search the TPLC database by device name or procode to receive a full report about a particular product line.

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