What quality and regulatory steps are needed to get your COVID-19 related device on the market under FDA Emergency Use Authorization. The FDA has been very active in publishing new guidances and updates for COVID-19 related devices that are in high demand. RookQS has worked with many manufacturers and distributors around the world to address the COVID-19 related shortages on devices, diagnostics, and PPE. • Overview of the requirements for the COVID related devices and supplies under high demand during the current COVID pandemic • Overview on diagnostic and at home testing kits • Overview on hand sanitizer registration and testing for manufacturers and distributors • Overview on respirator regulations and testing for manufacturers and distributors This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.

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”
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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!!!