FDA's Case for Quality: What, Why, and How? Changing the Regulatory Paradigm
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Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA's medical devices center is a focus on quality. The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. This program allows the FDA to recognize device manufacturers that are capable of consistently producing high-quality devices and continuously improving. Greenlight Guru is partnering with FDA CDRH to help spread the word and promote the Case for Quality initiative and its benefits to the medical device industry. This is the first of four presentations, learn about the others at greenlight.guru. Key points in this presentation: -Learn about CfQ – What it is, why we are doing it, and how we are engaging -Introduce pilot programs – Provide summary detail on various pilots at CDRH and associated with CfQ -Regulatory paradigm – How is FDA rethinking the regulatory engagement Watch this presentation, by Franciso Vicenty, the Case for Quality Manager of the FDA, here: https://www.greenlight.guru/webinar/fda-case-for-quality
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FDA's Case for Quality: What, Why, and How? Changing the Regulatory Paradigm
- 4. www.fda.gov It is all about the patients! What does it take? • Focusing on quality • Collaboration and engagement from all stakeholders • Faster Innovation • Focus continuous improvement • An adaptive and responsive regulatory framework 4
- 9. www.fda.gov Voluntary Medical Device Manufacturing and Product Quality Pilot These changes reduce the burden and disruption of inspections, accelerate the review and approval process for changes, and shift resources to innovation and improvement Pilot program • 3rd-party maturity appraisal that leverages the Capability Maturity Model Integration (CMMI) framework to assess a medical device organization’s capability to produce high-quality devices and increase patient safety • Pilot was announced on December 28, 2017 and will run from January 2, 2018 and continue through December 28, 2018 FDA adjustments • Forgo surveillance, post-approval, and risk-based inspections • Manufacturing change notice submissions – Streamlined submission – Accelerated acceptance 2 business days vs. 30 days • Manufacturing site changes – Streamlined submission – Accelerated approval – 1 week target • Original PMA manufacturing section – Streamlined submission – Forgo preapproval inspection 9
- 10. www.fda.gov Value across stakeholders FDA • 30-Day Notices consumed 15-22 FTEs • Site Changes consumed 5 FTEs Manufacturers • $30M/month top line. • $1.2M/year savings 1 facility based on optimized processes and resource allocation (69 30-Day Notices) • FDA audit cost (10 Days) - $140K • Limited submissions and improvements due to regulatory resources • European product lines optimized faster/better than US. Patients/Providers • 11 product quality improvements at one facility to patients 60-days sooner • Increase product improvements • Faster implementation of corrections to safety issues 10 Value analysis considered the submissions received at FDA in 2016 and the 30-dDy Changes submitted by one location of one manufacturer, the FTEs used during previous FDA audits, and estimated monthly revenue impact of approval delays for a recently released product.
- 11. www.fda.gov Optimizing Quantitatively Managed Defined Managed Initial How is a maturity appraisal different? 11 • Focus is on actual capabilities and activities of value add for the organization • Interviews / data collection from people who perform work which provides an atmosphere for actual inspection to improve from • Drives a conversation of how to actually improve in a way that makes sense to the business Medical Device Discovery Appraisal • Looks beyond the CFR, and not just strict compliance • Interviews / data collection are not from just those in the “front room” or those who manage audits • Does not focus on just a corrective action list to “get into compliance” The Difference
- 13. www.fda.gov
- 14. www.fda.gov Mechanics of an appraisal 14 • Practice area results & overall result for an organization • Aggregate metrics of issues, resolutions, and responsiveness • High level view into organization’s risks and issues • Aggregate of all products at facility and not for individual products (instructions provided) • Specific to organization depending on how they manage that data, tools, and function of the organization • Discovery appraisal conducted by a 3rd party, including – interviews – document review as able – crafting of findings – verification of findings – presentation of readout – heat map On-site Measurements Report out
- 15. www.fda.gov What information is collected? 15 In scope practice areas Estimating Planning Monitor & Control Configuration Management Requirements Development and Management Process Quality Assurance Implementation Infrastructure Technical Solution Product Integration • Baseline collection: Heat map of performance within a practice area against a model • Allows for quick visualization to understand where the organization has met the intent of the practice descriptions • Organization and PMO receive a copy of the full appraisal Organization's Results • The FDA receives practice area average results & overall result for each participating organization: Results reported to FDA • Organizations will have an opportunity to re-baseline Governance Managing performance & Measurement
- 19. www.fda.gov Streamline Non-Product Computer System Validations 19 • Lag in the medical device industry in implementation of automated systems, data analysis systems, and manufacturing technologies due to lack of clarity, outdated auditing activities, and perceived regulatory burden. This reduces a manufacturers capability to learn, react to issues, and improve product quality. Why • Drive a paradigm shift in applying value- driven and patient-focused approaches to streamline non-product software CSV. • Focus on critical thinking and risk-based, agile approaches to validation and streamlined documentation. What • Applying streamlined approaches and practices • Piloting modified Computer System Validation protocols with industry participants • Guidance development centered around assurance activities for this category How
- 20. www.fda.gov Non-Product CSV Modification Impact Activity Current Approach Modified Approach Impact Streamlined Analytics Reporting: Consumes 43 hours per report Reduced to 10.5 hours per report • $90 per hour average cost • $3870 per report vs $945 • Drives reduced use of analytics and operational research Risk-based software vendor qualification: Approx. 2000 hours of labor 80% reduction in labor • $100 per hour average cost • $200,000 à $40,000 Ad-hoc/Unscripted Testing (AGILE): 14 hours per test script 2 hours • A $10B firm with 100 systems could save $1.62M annually, which can be reinvested into innovation and product quality improvement • More robust software (Safer Product) Piloted Risk-Based CSV Validation Process: CSV does not account for risk or application Risk-based and patient focused • Culture change and staff engagement • 30 Day qualification à 2 days • 25+ CSV Backlog à 6 Closing/5 in process 20
- 21. www.fda.gov Information, Engagement, and Collaboration 21 • For additional information, enrollment, or feedback • http://mdic.org/cfq/ • http://mdic.org/cfq/enroll/ • caseforquality@fda.hhs.gov • Program Updates • http://mdic.org/mdicx/ • Public Workshop • https://www.fda.gov/MedicalDevices/N ewsEvents/WorkshopsConferences/uc m568069.htm • Pilot FR Notice • https://www.federalregister.gov/docum ents/2017/12/28/2017- 28044/fostering-medical-innovation- case-for-quality-voluntary-medical- device-manufacturing-and-product • For any issues or concerns contact • Francisco.vicenty@fda.hhs.gov or Jennifer.Kelly@fda.hhs.gov.