Medical device regulations 510k

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https://www.sigmabiomedical.com
Medical Device Regulations
510(k) Premarket Notification Principles

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Welcome!
Thank you for watching this introductory presentation on medical device
regulations and the 510(K) Premarket Notification Process. We hope you find this
presentation helpful and informative. For more information, please visit us at
http://www.sigmabiomedical.com

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Note to the Viewer
In this presentation we want to outline the principles of medical device regulations and
the 510k Premarket notification process for an efficient product approval with the FDA.
Instead of presenting the 510K process from a pure regulatory approach of outlining the
510k premarket notification process, we want to present the concept behind device
regulations so it can be understood, taken into account and effectively implemented
from and during the product development and manufacturing process.
We believe this approach will help medical device manufacturers stay in compliance,
obtain market clearance and provide a safe and effective product to their consumers

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Need for Medical Device Regulations
Medical Device Compliance Areas
FDA Regulations for Medical Devices
In this short presentation we are covering the following topics
510(k) Premarket Notification Process

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Medical products intended to
diagnose, treat, manage or
mitigate a disease condition
may cause injuries on patients
•Product development and manufacturing engineers need to determine, analyze
and address potential risks medical products pose to patients. Risks include
direct or indirect patient harm, wrong diagnoses or improper treatment and
disease management processes.
Need for Medical Device Regulations
•Risks can be caused by weak product design, lack of adherence and compliance
to safety standards, material and component failures or improper device use.

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Lack of proper controls and quality procedures
cause weaknesses in the design and
manufacturing, which in turn prompt the devices
to malfunctions.
Labeling
Improper device labeling including inaccurate or
insufficient user instructions can cause operator
errors increasing safety risks to patients.
Electrical Systems
Failures in electronic design can cause electrical
safety hazards such as high leakage currents that
can harm patients and operators
Electromagnetic Interference
Improper grounding and shielding cause devices
to emit or receive radiation beyond allowable
limits; potentially affecting or interfering with
device operation
Radiated Energy
Radiated energy beyond limits cause injuries and
bio effects on biological tissues.
Software
Software bugs and lack of software validation
and verification can cause incorrect
measurements, wrong diagnosis and improper
treatment settings
Some of the risks and their effects include
Quality

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Although medical devices
can benefit and be a
useful tool to improve the
health of patients, they
can also cause harm
.
• We then need a balance between benefits and risks to ensure new medical products are developed,
manufactured, introduced and used in a safe and effective manner.
Benefits vs Risks
Maximizing Benefits - Minimizing Risks
• The Food and Drug Administration FDA has been established as an agency in charge of promoting and
protecting public health. The FDA has the power to supervise and enforce regulations related to the marketing
and safe and effective use of medical and health products.

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The FDA protects consumers
• To keep a balance between benefits
and risks of medical products, the FDA
sets regulations for the manufacturing,
marketing and distribution of medical
and health products including medical
devices, drugs, cosmetics, food and
biological products.
• The FDA establishes controls and
regulations to protect consumers from
the risks of medical and health
products and the negative effects they
can cause on the patients’ and
consumers’ health
SigmaBiomedic

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What are the main Medical Device Regulation Areas to ensure Patient Safety and Device
Effectiveness?
Labeling, Claims and Intended
Use of products
Product Safety &
Effectiveness
Product Development and
Manufacturing operations
Product Registration, Records,
Customer Complaints &
Adverse Reactions
Medical Device Compliance Areas
We will briefly discuss each of these areas of compliance

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To make sure the
technology and
intended use of
the product have
been clinically
validated and
proven effective
To make sure
products are
properly labeled
and safely used
according with their
intended use
To make sure
benefits and claims
are substantiated
by performance
data as well as by
scientific and
clinical evidence
Intended Use, Claims and Labeling
What is the importance of intended use, proper claims and labeling?

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Not validated technology
“Quack” technology with lack of clinical studies. No
scientific principles behind the technology and
mechanism of action
Some non compliant Cases
Not validated Claims and misleading statements
Devices that claim they can diagnose any type of
disease. Augmented adjectives: The “best imaging
technology”
Insufficient instructions for use
Instructions are not clear to the user. Not warning
messages. No safety precautions. No declared
indications for use.

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To minimize
risks and to
ensure patient
safety
To minimize
adverse
product
interactions
To ensure
effectiveness
for their
intended use
Importance of Product Safety & Effectiveness

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Cancer Treatment Device
25 MeV Radiotherapy Machine –
X-rays & Electrons. 200 rad (e) or
25000 rad (x)
System Setting Error
Error on selection, Software bug,
Beam not reset. No maximum
output controlled
Error Effects
Patient received 25000 MeV,
“malfunction 54 displayed”.
Technician fired 2 more times
4 months later patient died
Failure Mode Case
Software Bug, Lack of Training, Improper Labeling

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01Manage Risk
Implement Risk Management
Policies and Procedures for
products, manufacturing processes
and business operations
02Control Design
Follow design controls &
engineering standards in
product development
03Manage Quality
A proper quality management
system needs to be
implemented in operations
04Use Safe Materials
Materials and components
need to be medical grade or
generally recognized as safe
05Test and Validate
According to safety standards
to make sure product is safe.
Testing can reveal weak and
non-compliant areas
06Monitor Device Use
Follow, and document
customer complaints and
take proper action
6 Ways to Product Safety

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To protect consumers and patients, the FDA regulates and
establishes controls for the marketing, manufacturing and
distribution of Medical Devices and Health Products.
FDA Regulations for Medical Devices
The controls and regulations are aimed to maximize
benefit, minimize risks and guarantee a safe and effective
use of products
FDA regulations depend on the type of product and their
risk level. The higher the risk the more strict the controls
and regulations

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Medical devices are classified by the FDA and grouped into 16
medical categories referred to as panels. A medical device is
assigned to a class based on the level of control to assure
product safety and effectiveness. The classes are:
• Class I
• Class II
• Class III
Medical Device Classification
Device classification depends on the risk level of the device, that is, the risk the device poses to
the patient and/or the user is a major factor in the class it is assigned. Class I includes devices
with the lowest risk and Class III includes those with the greatest risk.

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•Medical products need to be listed or registered with the FDA before they can be
marketed in the US. This ensures a good level of control by the FDA on the
product marketing and distribution.
Medical Device Registration
•Prior to being listed, and depending on classification, medical devices might
need to go through a process of device evaluation by the FDA
•The process evaluates product safety and effectiveness, as well as validity of
claims, intended use, indications for use and labeling
•To start the process, a submission seeking market clearance needs to be
started with the FDA by the manufacturer or sponsor of the product

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Two types of medical device clearance submissions exist: 510k
Premarket Notification and Premarket Approval PMA. Some
devices are exempt from these submission requirements and
only need to be listed
Types of Product Submissions
The class to which a particular medical device is assigned and its
risk level determines the type of submission required for FDA
market clearance.
If the device is classified as Class I or II, and if it is not exempt, a
510k will be required for marketing.
For Class III devices, a premarket approval application (PMA) will be
required unless the device is a preamendments device and PMA's
have not been called for. In that case, a 510k will be the route to
market.

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•The FDA provides a general guidance on how to submit a 510k
Premarket Notification. It can be searched on the Web under
FDA 510k guidance
510(k) Premarket Notification Process
•Special guidance documents exist depending on the product type
and product code.
•The guidance document specifies ways to demonstrate safety and
effectiveness for the type of product being reviewed
•The 510k process is mainly aimed to demonstrate the product is
safe and effective for their intended use, and that the product is
substantially equivalent to an already cleared product

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• That the technology and action principle for the intended use of the product has been
previously evaluated and found effective for other similar products using the same technology
with similar manufacturing processes and materials
Substantially equivalence SE, implies
• The action principle and technology do not introduce new safety or effectiveness concerns as
it has been previously evaluated and demonstrated in scientific and clinical literature for the
intended use.
• In many cases it also means that similar products have been on the market prior to 1976. For
this reason, clinical data most likely will not be needed. FDA will thus rely upon well-designed
bench and animal testing to demonstrate adequate performance.
• The product has been tested and by performance data found safe and effective for their
intended use
• Product labeling is according to the intended use; claims are substantiated by scientific and
technical evidence, and user instructions ensure safe use of the product

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Product code and classification
This section will tell the FDA the
classification panel for the subject
device so the submission gets
directed to the proper review team
for evaluation
Main elements of a 510k Submission Document
Device Description
This will provide the FDA reviewers
with a clear and concise description
of product features, specifications,
functionality, technology and
mechanism of action.
Predicate device comparison
This section is aimed to compare the subject product
to an already cleared device to demonstrate that they
are similar in technology, mechanism of action,
materials and manufacturing process, and thus no
new safety or effectiveness concerns are introduced

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Performance Data to address Risks to Health
This is aimed to demonstrate safety, and or compliance with safety standards. It is
also aimed to show that product features have been successfully verified and
validated for their intended use. Risk management needs to be demonstrated.
Materials and Component Characterization
If applicable, this section is aimed to demonstrate that patient contact materials
are biocompatible and do not cause or pose risks to health.
Labeling
This is aimed to show the FDA reviewers that proposed manuals, brochures and
promotional materials provide sufficient information for the safe and effective use
of the product according with the intended use. FDA will review labeling to make
sure no unsubstantiated claims are included

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Administrative forms and payment
The submission needs to include:
• Proof of payment of FDA fees for 510k review
• Medical Device User Fee Cover Sheet (Form FDA 3601).
• Certification of Compliance with ClinicalTrials.gov Data Bank, FDA-3674*
• Cover Letter
• Indications for Use
• 510k Summary
• Standards Data Report for 510(K)s - FDA 3654.
• Truthful and Accuracy Statement (21 CFR 807.87(k))
Main elements of a 510k Submission Document

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Find and Analyze Similar Devices (Predicate devices)
From the FDA medical device database or Web search, find devices that are similar in technology, mechanism of
action, and intended use to your device. Find from the results, product code, classification and 510k summary. From
510k summary determine product description, and performance data or testing standards, if included.
Some initial tips to prepare a 510(k)

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Some initial tips to prepare a 510(k)
Analyze Applicable Regulations
From product code find applicable regulations. Check guidance and from
there required testing to address risks to health. Analyze recommended
documentation
Setup approval strategy
Determine approvable product features, functionality and their
corresponding testing, validation and verification activities. Define
intended use and claims so these are similar to predicate devices’. Make
sure labeling is correct and addresses all required items. Do a check list
of 510k requirements.

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Pre-submission
510(k) Preparation
510(k) Review
Start
Predicate Analysis,
classification, product code
Analysis of applicable
Regulations – guidance, strategy
Administrative review for
510k document completeness
510(k) interactive
Review – Answer Requests
Time line of events to prepare a 510(k)
Example of time line
Performance Data,
testing, validations
Market Clearance

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week2 week4 week6 week8 week10 week12 week14 week16 week18 week20 week22 week24 week26
Product review
Predicate analysis
Regulatory analysis
Performance data
510k preparation
510k submission
Administrative acceptance
510k Interactive Review
Clearance
510k Project Gantt Sample*
*time line differs based on product type, as well as on existing and needed testing and performance data when 510k process starts

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510(k) Submitted
Administrative Review,
Interaction &
Acceptance
Interaction with FDA
Reviewer and feedback
to solve issues
SE Letter
Market Clearance
Time Line for 510(k) Clearance

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USA
Hialeah Technology Center
601 West 20 St
Hialeah, FL 33010
Tel (305) 925-1260
Colombia
Campus NOVA
Universidad Javeriana
Cali, Colombia
Tel 316-833-8183
Argentina
Gabriela Menna
Buenos Aires, Argentina
Regulatorybiotech@gmail.com
Email / Website
sigmabiomedical@gmail.com
www.sigmabiomedical.com
Get in touch with us!

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Medical device regulations 510k

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