In this webinar hosted from EMMA International's Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and device listings.

1. www.emmainternational.com
Nikita Angane, MS
Lead Quality Engineer
Regulatory Affairs 101
for Medical Device
Start Ups
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2. Leaders in FDA
Compliance Consulting
EMMA International Consulting Group, Inc. is a global leader in management consulting services. We focus on
quality, regulatory, and compliance services for the Life Sciences industry.
EMMA International is certified as a Women’s Business Enterprise (WBE) through the Women’s Business Enterprise
National Council (WBENC), the nation’s largest third party certifier of businesses owned and operated by women in
the US.
EMMA International is certified to ISO 9001:2015, a globally recognized quality management standard developed by
the International Organization for Standardization (ISO). Achieving this certificate proves our continued
commitment to continuous improvement and delivering high quality expert services to our clients.
We recognize the commitment to supplier diversity that is embraced by corporations and government agencies today,
and we can add diversity to your supply chain.
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3. • FDA Centers
• Pathways to market
• What is RTA (Refuse to Accept)?
• Labeling
• Registration and Device listing
• Quality Systems
• Additional considerations
Key Points
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4. • Medical Devices are regulated by:
• Devices – Center for Devices and Radiological Health (CDRH)
• Office of Combination Products (OCP)
• Within the Office of Special Medical Programs
• Serves as focal point for medical product classification and assignment issues
FDA Centers
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5. • Definition: A product comprised of two or more regulated
components, i.e., drug/device, biologic/device, drug/biologic, or
drug/device/biologic, that are physically, chemically, or otherwise
combined or mixed and produced as a single entity
• The mode of action of a combination product that
provides the most important therapeutic action of
the combination product is called as the ‘Primary
Mode of Action’ and determines the Lead Center.
• For combination products whose PMOA is a
device, CDRH is the lead center and CDER (Center
for Drug Evaluation and Research) becomes the
consulting center.
Combination Products (21CFR3.2(e))
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The different pathways available to get your product on the market:
Medical Devices
510k (Traditional, Special, Abbreviated)
De Novo Classification
Emergency Use Authorization (EUA)
Pre-Market Application
Humanitarian Device Exemption
How to Get Your Medical Device on the Market

7. How to Get Your Medical Device on the Market
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• Product
development
• Testing
• Developing
specifications
Develop your
device
• FDA classification
(Class I, II, III)
• Start building a
regulatory strategy
Classify your
device/understand
regulatory controls • Select the right
premarket
submission
• Nonclinical vs
clinical testing
FDA submission
• Design controls
• Labeling
• Maintaining a
compliant QMS
Ensure compliance
to QSR and other
regulatory controls

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Steps in Determining Pathway to Market
CombinationProduct
Combination
Product
I.Decide
Intended Use
of the Device
I.Determine
Product
Classification
I.Determine
Product Code and
Regulation
Number
I.Identify a
Predicate
Device
I.If you do not find a product
code and/or a predicate
device and if the subject
device is low-moderate risk-
The DeNovo Classification
might be the way for you to
go.
I.Submit a
Pre-
Submission, if
Required.

9. • This submission will be
particularly helpful if a product
code does not exist for your
product.
• The designation can be
reconsidered if the firm disagrees
with the FDA.
• In the case where a firm submit an
application and if the application
gets rejected, there is no
reconsideration given to the firm.
Requests for Information 513(g) ?
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10. • You may formally send a request to the FDA to determine the
primary mode of action of the product in case of a combination
product and determine the lead agency center
Request for Designation (21CFR 3.2(j))
• Submit the following in an RFD:
Medical product
description (e.g.,
components,
composition
Intended Use
Test reports
Description of related
products, including the
regulatory status of
those related products
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11. Pre-Submissions and Pre-Request for Designation (pre-RFD)
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This Photo by Unknown Author is licensed under CC BY
• Pre-submissions
• Mechanism to communicate with the FDA
• You have the opportunity to ask questions and request a written
feedback or a teleconference.
• You need to be very specific in the questions you are asking FDA
• Pre-Request for Designation
(pre-RFD)
• It is an informal and non-binding
feedback from the FDA
• No user fees associated with this

12. • In order to focus FDA’s resources on the review of complete
submissions, FDA has formulated a Refuse to Accept Policy.
• According to this policy, FDA performs an early review of the
submission against a specific acceptance criteria which is
laid out in the Refuse to Accept checklist.
• The FDA informs the submitter within 15 calendar days
whether the submission contains all the elements that are
required and inform them of any missing elements.
• This administrative review process is based on the objective
criteria in the acceptance checklist and the quality of data is
not assessed at this stage.
What is Refuse to Accept (RTA)?
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13. • Some of the requirements in RTA checklist:
• Whether the pages are numbered in the
submission
• Whether a 510k summary has been submitted
• If there is a table of contents among many other
things
What is Refuse to Accept (RTA)?
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• The RTA checklist must be included with your 510(k) application.
• If the FDA makes a determination of Refuse to Accept, the sponsor
has the option to withdraw its application and the user fees are
refunded.

14. • Requirements surrounding the label of medical devices is laid out in
21CFR801.
• If not all, most of the advertising is also considered as a label.
• The labelling is submitted with the application to ensure that the labelling
does not provide any false claims to the consumers.
Labels
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• UDI (Unique Device Identifier):
• It is important that you assess the requirements
of UDI for your label
• UDI helps in the identification of your product
from manufacturing to distribution and patient
use which ultimately improves patient safety and
modernize post market surveillance activities.

15. • After you receive your product
approval/clearance/classification
you have 30 days to pay the
MDUFA fees, register your
establishment and list your product
with the FDA.
• The MDUFA fee changes every year
and there is no small business fee
for establishment registrations.
• We will discuss MDUFAs in detail
in the next slides
Establishment Registration and Listing
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This Photo by Unknown Author is licensed under CC BY-NC

16. • Every medical device manufacturer is required to follow Quality
Systems Regulation 21CFR 820.
• A manufacturer must make changes to their manufacturing
processes, design changes, handle complaints under the
umbrella of their quality management system.
• The key components of a QMS are identified below:
Quality System Regulations
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Management
Controls
Quality
Audits
Personnel CAPA
Complaint
Management
Adverse
Event
Reporting
Design and
Development
Controls
Change
Management

17. • As part of the Quality Management System, the following
regulations must be incorporated:
Additional Requirements
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21CFR 803
Medical Device Reporting
ISO 14971:2019
Medical devices — Application of
risk management to medical devices
— Recognized by the US FDA and
accepted by all other countries
except for Europe.
ISO 10993
Biological evaluation of medical
devices (If the device requires
biocompatibility assurance)
IEC 62304
Medical device software — Software
life cycle processes (If the device is
or incorporates a software)
IEC 62366
Application of usability engineering
to medical devices (Must be
considered within your risk
assessment and design of the
product)

18. • There are user fees associated with each application.
• There are no fees for Pre-RFD , RFD or pre-submissions.
• However, there are fees for:
• Establishment Registration
• 510(k) submission
• 513(g) submission
• DeNovo submission
• Pre-market application
MDUFA (Medical Device User Fee Amendments)
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19. MDUFA (Medical Device User Fee Amendments)
This Photo by Unknown Author is licensed under CC BY-NC
• Small businesses are eligible for a waiver or a reduced fee for some
submissions.
• In order to qualify to receive the small business designation, the business,
including its affiliates must have its gross receipts and sales less than
$100 million for the most recent tax year.
• In addition, a small business is
eligible for a "first premarket
application/report" fee waiver, if
the business’s/affiliate’s gross
receipts or sales are no more than
$30 million.
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20. Common Problems
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• Not considering or budgeting for QA/RA
needs from the beginning of product
development.
• Underestimating the amount of work
required to get your product on the
market.
• Thinking they are done after regulatory
approval.
• Do too much/Do too little in terms of
compliance activities.

21. How to Assess Your Current Needs/System
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• If you’ve already began product development:
• Gap Analysis
• Internal Audit by a third party
• If you are still wondering where to start:
• Understand what regulations you are required to comply
with and any applicable exclusions
• Consider the resources needed to complete the required
regulatory deliverables
• Engage QA/RA experts as soon as possible
• EMMA International’s Regulatory Strategy service has
helped many companies determine their right path to
market and saved them time and money.

22. How to Write a Request for Designation (RFD)
https://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm#IIIB
How to Prepare a Pre-Request for Designation (Pre-RFD)
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM534898.pdf
Refuse to Accept Policy for 510(k):
www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-
510ks
Device Labeling:
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
Device Registration and Listing:
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-
registration-and-listing
Additional Resources
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