How to get your COVID-19 Related Medical Device to Market Under FDA Emergency Use Authorization (EUA)
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The document discusses the process for getting COVID-19 related medical devices authorized under FDA Emergency Use Authorization (EUA), highlighting the importance of compliance with quality systems and regulatory requirements. It includes an overview of essential EUAs, diagnostic classifications, testing requirements, and labeling processes for such devices. The content emphasizes the expedited path to market for devices during emergencies and provides resources for manufacturers to ensure they meet regulatory standards.
How to get your COVID-19 Related Medical Device to Market Under FDA Emergency Use Authorization (EUA)
- 1. Getting your COVID-19 related device on the market under FDA Emergency Use Authorization JUNE 4, 2020 WEBINAR
- 2. “Greenlight Guru Software is the handrail for Medical Device Development and Documentation” FEATURED IN 75 years industry experience 275k podcast listeners #1 blog and podcast in the industry 90k look to us for the latest in medical device quality MEDICAL DEVICE QUALITY IS ALL WE DO, AND WE’RE ALWAYS AHEAD OF THE GAME. “My QMS is world class” “One stop shop for MDQMS”
- 3. Rook Quality Systems Rook Quality Systems is a consulting firm dedicated to helping startup to mid-sized medical device companies develop and maintain effective and efficient quality systems. We provide specialized and custom consulting services for all classes of medical devices, including medical software and combination devices. Quality System Design Audit Support Regulatory Submission Support (Int’l) DHF/ TF Creation Software Validation Design Control Risk Management Quality System Training
- 4. Intro to Kyle Rose KYLE ROSE, PRESIDENT Medical Device expert specializing in development of efficient quality systems for startup to large medical device companies including diagnostics. As President of Rook Quality Systems Mr. Rose works as a quality and regulatory expert advisor for 80+ companies ensuring compliance of their medical device to the applied standards and regulations. Works closely with clients to develop and implement efficient quality systems to maintain compliance and get novel devices to market faster. Quality System Development ISO 13485:2016, 21 CFR 820, MDD and MDR, ISO 14971 Design Control Risk Management Medical Device Software Validation Product Development Internal and Supplier Audits Complaint Handling Greenlight Guru Post Market Surveillance & PMCF Verification and Validation Corrective and Preventative Actions
- 5. Presentation Highlights • Overview of FDA guidances and Emergency Use Authorizations • Why EUA • FDA Communication • Quality System compliance • EUA Process for specific devices • IFU/Labeling • Distribution
- 6. Requirements for COVID-19 EUA • FDA guidances and Emergency Use Authorizations • Regulatory compliance • Many standard requirements have been changed/removed from EUAs • Testing • Quality system compliance • Labeling
- 7. EUA Process Overview • Designed to allow Emergency Use Authorization for devices, diagnostics, and drugs during a medical emergency • Regulations/submissions are reduced to get more products to market faster to assist with medical emergency – COVID-19 • Pre-EUA Submission process similar to FDA Pre-Submission process • EUA Approval granted in EUA letter issued by FDA • Labeling and IFU must indicate product only for EUA use • Additional information/testing may be submitted post EUA
- 8. Why Submit EUA • Ability to get your pandemic response device to the market quicker • Gather real world evidence on the use of your device and/or software • Use information to support eventual 510k • First chance to market for many devices • Increased indications or markets
- 9. EUA Quality System – Bare Minimum • QMS needs to comply with the minimum requirement for EUA • Document Control/Training • Design Control/Risk • Supplier Assessment • Traceability • Complaint Handling/Customer Feedback • Adverse Event Handling • SOPs should be established • Work Instructions for inspection/assembly/manufacturing/testing • Validations required for high volume manufacturing • Clinical Plan may be needed depending on device
- 10. IFU and Labeling for EUA • FDA will review all proposed labeling and Instructions for Use for your EUA submission. • IFU/Labels for each device that has received an EUA is listed on the FDA website • Review similar devices/diagnostics when creating your IFU/Label • This test/device has not been FDA cleared or approved; • This test/device has been authorized by FDA under an EUA for use by authorized laboratories; • This test/device has been authorized only for the specific EUA details • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics/devices for detection and/or diagnosis/device indication of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- 11. COVID-19 Diagnostics (Dx) • Diagnostics split into 3 main categories • Molecular/Serology • Antibody • Antigen • FDA Provides Templates for each with an overview on information required for the EUA • EUA request • CLIA regulatory requirements
- 12. Dx Manufacturer EUA Requirements • Description of test and what specifically it detects • Test technology (RT-PCR, ELISA, …) • CLIA regulatory requirements for testing labs • Specific antibodies/antigens detected related to SARS CoV-2 • Description of test steps • Control materials or steps provided with test • Interpretation of results • Overview of manufacturing and distribution
- 13. Dx Manufacturer EUA Requirements - Continued • List of components/reagents included with the test • Test capability – sample throughput and time required • Reagent stability • Analytical Sensitivity and Specificity • Cross Reactivity with following viruses(specific for each type of test) anti-influenza A (IgG and IgM) anti-influenza B (IgG and IgM) anti-HCV (IgG and IgM) anti-HBV (IgG and IgM) anti-Haemophilus influenzae (IgG and IgM) anti-229E (alpha coronavirus) anti-NL63 (alpha coronavirus) anti-OC43 (beta coronavirus) anti-HKU1 (beta coronavirus) ANA anti-respiratory syncytial virus (IgG and IgM) anti-HIV
- 14. COVID-19 Home Testing Kits • List of components/reagents included with the test (GMP) • Type of sample being collected • Testing on stability of sample • Detailed Review on IFU and Labeling • Usability Study • Usability Protocol • Use Risk Analysis • Usability Report/Survey • Distribution Plan
- 15. Hand Sanitizer Registration & Testing • Pharmaceutical Registration Required for Hand Sanitizer • DUNS number • CDER direct • Establishment registration • Labeler code request • Product listing • NDC product code • Testing needs to be compliant with FDA/ISO standards
- 16. Respirator Registration & Testing (N95) • Regulatory • 21 CFR 878.4040 • NIOSH 42 CFR 84.181 • 21 CFR 820 • Testing • ASTM F3387-19 • Labeling • Model number/part number • TC-Approval number • Business name • NIOSH • Filter design (N95) • Manufacturing • Control Plan/Risk Analysis
- 17. Additional Devices/Software • Make the case to the FDA for your specific device or technology • Multiple EUAs have been granted for devices not originally covered under EUA guidances • Describe use case and need • Identify how you comply with the EUA regulations • Start conversation with FDA • Provide labeling, testing, IFU for device
- 18. PPE/COVID Supply Distribution • Determine requirements for devices/PPE for import/registration • Verify information from supplier • FDA Registration, ISO, CE • Verify testing certificates • Compare testing requirements with EUA • Register as importer/distributor (if applicable) • Maintain traceability of devices/PPE distributed • Additional information on COVID related distribution www.hyper-clear.com
- 19. Questions? Contact info@rookqs.com for more questions, comments, or to set up a meeting. One of our consultants will be sure to reach out to assist! Visit www.RookQS.com for additional blog posts and content on COVID related devices Thanks Greenlight.Guru!!!