1) Strategies for ensuring a medical device released under an Emergency Use Authorization (EUA) stays on the market after the EUA expires include pursuing a premarket submission such as a De Novo or 510(k). 2) Key considerations in preparing a premarket submission for a device released under an EUA include leveraging any clinical data collected under the EUA if possible, conducting a gap analysis against regulations and standards, and seeking funding assistance from organizations like BARDA or the CDC. 3) Recommended strategies include having pre-submission meetings with the FDA, leveraging available EUA clinical data for the premarket submission, conducting a gap analysis of applicable quality and regulatory requirements, and seeking support from

1. WELCOMEE
Strategies for Ensuring a Medical Device Released Under EUA
Will Stay on the Market After EUA Expires
Wednesday, June 3, 2020
Greenlight Guru Virtual Summit

2. 2The RND Group 2020
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3. 3The RND Group 2020
RND Group
Presenters
Brad Graves
Principal Project
Manager
Cathy Wilburn
Director of Quality
Assurance and
Compliance

4. 4The RND Group 2020 4
Agenda
RND Group Overview03
Agenda02
What is EUA04
Differences between EUA and Premarket
Submissions05
Considerations in Preparing a Premarket
Submission for an EUA Medical Device06
Meet the Team01
Strategies for Preparing a Premarket
Submission07

5. 5The RND Group 2020
About
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6. WHAT IS
EUA

7. 7The RND Group 2020
FDA Commissioner may
allow unapproved medical
products or unapproved
uses of approved medical
products to be used in an
emergency to diagnose,
treat, or prevent serious or
life-threatening diseases
or conditions caused by
CBRN threat agents when
there are no adequate,
approved, and available
alternatives.
The Emergency Use
Authorization (EUA)
authority allows FDA to help
strengthen the nation’s
public health protections
against CBRN threats by
facilitating the availability
and use of MCMs needed
during public health
emergencies.
Emergency
Use Authorization

8. 8The RND Group 2020
Recent
Emergency Use Authorizations

9. 9The RND Group 2020
Public Health Emergency
Declared
April 26, 2009
Health Emergency Determination
Renewed
July 24, 2009
Health Emergency
Determination Renewed
Dec 28, 2009
Emergency Use Authorization
Terminations
Health Emergency
Determination Renewed
Oct 1, 2009
Health Emergency
Determination Renewed
Mar 26, 2010
Swine Influenza A (now known as 2009 H1N1 Influenza) Timeline:
18 organizations that submitted EUA requests for IVD devices were
notified
Termination of
Declaration and EU
June 25, 2010

10. 10The RND Group 2020
Personal Protective
Equipment and
Related Devices
Highly Complexity
Molecular-Based
Laboratory
Developed Tests
In Vitro Diagnostic
(IVD) Products
Ventilators and Other
Medical Devices
Therapeutics TOTAL
COVID-19 EUA Approvals – To Date
71
28
12 20 3 134

11. DIFFERENCES
BETWEEN EUA AND OTHER
FDA SUBMISSION
PATHWAYS

12. 12The RND Group 2020
EUA vs. Other FDA Approval Pathways
Requirements Emergency Use Authorization (EUA) De Novo/510(k)
Special Circumstances Requires declaration by the HHS
Secretary that circumstances exist
justifying the EUA; There is no
adequate, approved, and available
alternative to the product
No
Duration Temporary – remains in effect for the
duration of the declaration, unless
revoked sooner
Not Limited
Analytical Evaluation Limited Full Validation
Clinical Evaluation Limited Full Validation
cGMP Expected but limits or waivers may be
granted in an EUA on a case-by-case
basis
Required

13. 13The RND Group 2020
cGMP Requirements
“Quality System Information for Certain Premarket Application Reviews; Guidance for
Industry and FDA Staff” expects submitting procedures and design history:

14. 14The RND Group 2020
Studies EUA vs. De Novo/510(k)
– NAAT (molecular)
NAAT Characteristic Definition Emergency Use Authorization (EUA) De Novo/510(k)
Limit of Detection (LoD) Minimum concentration of virus that is
detectable
Yes Yes
Inclusivity Detects all related viral strains Yes
All in silico allowed
Yes
Some in silico
Cross Reactivity Presence of other viruses does not
generate false positive
Limited
Some in silico
Full Validation
Some in silico
Interference Incorrect result caused by presence of
substance or process
Situation specific
Microbial and Endogenous
Yes
Precision How repeatable the test result is,
compared to “gold standard”
No Yes
Multi-site
Fresh vs. Frozen Status of sample Fresh specimens preferred, frozen and
in silico allowed
Fresh specimens preferred
Clinical Evaluation Approach and breadth of clinical
sample testing
Limited – natural clinical specimens
30 positive samples, 30 negative samples
Full validation – natural clinical
specimens
Minimum 3 sites

15. CONSIDERATIONS
PREPARING A PREMARKET
SUBMISSION FOR AN EUA
MEDICAL DEVICE

16. 16The RND Group 2020
EUA IVD to Full Market Release
Statistics
H7N9 MERS-CoV Ebola Enterovirus D68 Zika
EUA
Declaration
April 19, 2013 May 29, 2013 August 4, 2014 February 6, 2015 February 26, 2016 Total
Original EUA Diagnostics:
39
Total 3 2 13 1 20
EUA Re-authorizations and Amendments:
18/61
Total 1 2 31 0 45
De Novo or 510(k) Transitions:
6
Total 0 2 1 0 3

17. 17The RND Group 2020
Pre-Submission
Mar 2016
Pre-EUA Submitted
Mar 2016
Amendment I
Mar 2017
Case Study: Successful Transition
from EUA to Permanent Approval
EUA Authorized
Aug 2016
Amendment II
May 2017
• Case study for Zika virus device (ZIKV Detect™) demonstrates 2 years after last EUA amendment to
achieve full market clearance.
• Total effort to achieve De Novo clearance was 3 years and performed in parallel to EUA efforts.
Received BARDA Support for
permanent clearance
Active communication,
pre-submission meetings with FDA
May 2019 Market Authorization

18. 18The RND Group 2020
Factors that organizations with an EUA must consider before investing in a
permanent submission:
• Time investment
• Cost investment ($24M average for 510(k))
• Is the health emergency short-term or permanent?
• Is EUA device competitive in the market?
Why Are There Few Transitions
to Permanent Market Status?

19. STRATEGIES
PREPARING A PREMARKET
SUBMISSION

20. 20The RND Group 2020
Strategies to Consider when Pursuing De Novo / 510(k) During
EUA
• Pre-submission Meeting(s), active communication with FDA
• Leverage EUA Clinical Data, if possible
• Gap Analysis/Audit of Applicable Regulations, Standards, and
Guidance Documents
• Leverage BARDA, CDC for funding, clinical study help
Overview

21. 21The RND Group 2020
The Pre-Submission allows you to request formal feedback on your medical device before you make the
move to submit your De Novo or 510(k).
• Pre-submission definition is part of the FDA’s Q-Submission program
(https://www.fda.gov/media/114034/download)
Strategy:
Pre-Submission Meeting
Benefits of a pre-submission meeting include:
• Develop 1:1, personal contact with the FDA
• Remove risk elements from formal submission
• Advice/consulting on submission strategy
Preparing for a Pre-Submission does have costs – for consulting (up to $25k) – and typically takes
60-75 days.

22. 22The RND Group 2020
Strategy:
Leverage EUA Clinical Data
Certain types of clinical data generated for EUA, such as:
• Limit of detection
• Cross Reactivity
• Interference
may be possible to be leveraged, provided no modifications to device have been made since EUA
authorization
Other clinical data that requires multi-site data gathering, such as specificity, sensitivity will have to be
newly collected.
Consult with the FDA to confirm clinical data submission plans.

23. 23The RND Group 2020
Strategy: Gap Analysis/Audit of Regulations,
Standards, Guidance Documents
ISO 13485 (QMS)01
02
03
04
05
QMS
Risk
Software
cGMP
Cybersecurity
ISO 14971 (Risk)
IEC 62304 (Software)
21 CFR Part 280 (cGMP)
HIPAA, Cybersecurity

24. 24The RND Group 2020
Strategy: Leverage BARDA, CDC
• Creates own molecular tests for COVID-19 and
other viruses / diseases
• Can provide access to samples or data, assist with testing
• Can be source of “gold standard” for test precision
CDC – Centers for Disease Control
• Assists many IVD manufactures with funding, access to
difficult to obtain clinical samples
BARDA – Biomedical Advanced Research and
Development

25. 25The RND Group 2020
In Conclusion
ISO 14971
EN ISO 14971ISO 13485
HIPAA/GDPR
Compliant
IEC 62304
CFR Part 820 IEC 62366
EUA may last several years, but ultimately, it is temporary authorization
There are strategies, but no short cuts to transitioning to full-market
clearance
Planning and actions for pre-market submission should be performed
immediately and in parallel to EUA use

26. QUESTION & ANSWER