w04 - SF - Medical Device Regulation V02

MEDICAL DEVICE REGULATION
An Introduction to the Basics

2
Regulation is country specific

• Definition of regulation: A rule or directive made and maintained by
an authority
• In the USA, the U.S. Food and Drug Administration (FDA) restricts
sale and marketing of medical devices, requiring prior registration,
clearance, or approval (depending on classification).
• Threshold is “safe and effective”
• FDA is a federal government agency – does much more than
medical devices
3
Regulation is country specific

• Outside the USA, different standards and laws apply.
• In Europe, there is the CE mark process - primarily
about safety and performance consistent with
manufacturer’s intended use. The CE mark process
applies to much more than medical devices.
• Japan has the JFDA – similar to US FDA.
• China and some other countries rely primarily on

acceptance in country of device manufacture.
4
US FDA’s Medical Device regulations

• Cover manufacture (and importing) by restricting sale and
marketing
• Penalties
• Product seizure
• Fines
• Jail-time
5
What is a medical device?

A medical device is defined by what it does:
• diagnoses, cures, lessens, treats, or prevents human

disease
• affects the function or structure of the body
• does not achieve primary intended purposes through
chemical action
http://en.wikipedia.org/
6
Classification of Devices
3 classes of medical devices (I, II, and III)
Risk to user (patient) increases as

Classification increases
7
Class I – 47% of medical devices

• Simple and present a low risk of harm to the user
• Subject to “general controls” that are sufficient to protect
the user
• Registration and Listing, Quality System, Adverse Event
Reporting, Prohibitions against misbranding and
adulteration
• 95% are exempt from majority of the regulatory process
• Examples: non-powered breast pumps, elastic bandages,
tongue depressors, examination gloves, most hearing
aids, arm slings, microbial analyzers, keratoscopes
8
Class II – 43% of medical devices

• More complicated with a higher risk of harm to the user
• Require General AND Special controls
• Registration and Listing, Quality System, Adverse
Event Reporting, Prohibitions against misbranding
and adulteration
• Requirements for labeling, guidance, tracking,
design, performance standards, and post-market
monitoring
• Premarket Notification [510(k)]
• Regulatory standard is “Substantial Equivalence”
• Examples: powered wheelchairs, CT scanners, contact
lens care products, endolymphatic shunts, orthopedic
implants, dental implants
9
Class III – 10% of medical devices

• Most complex, highest risk of harm to the user
• Usually sustain or support life, are implanted, or present
potential unreasonable risk of illness or injury
• Have the toughest regulatory controls.

• Must be able to reasonably assure their safety and
effectiveness – difficult because more risky
• Require Premarket APPROVAL through a PMA
• Bench – Animal - Clinical
• May include post-approval study requirements
• Examples: pacemakers, implanted weight loss devices,

non-invasive glucose testing devices, medical imaging
analyzers, cochlear implants, breast implants
10
Quick check
What classification would you expect the following
devices to be?
• Cochlear implant
• Elastic bandages
• CT scanner
• Dental implant
• Pacemaker
• Crutches
11
FDA tracks adverse events (device-associated deaths, serious

injuries and malfunctions)
• This passive tracking is largely public – anyone with
direct experience can report (manufacturers MUST
report back)
• Data stored in something called the MAUDE database
• Useful for understanding common device failures within a

device type, company, or piece of industry
• What might be wrong with making decisions based on this

passive method?
12
MAUDE database of adverse events

An example…
Go to FDA.gov
Click “Medical devices” tab
Under “Tools & Resources” section, select “Medical Device
Databases”
Scroll down and select “MAUDE” – Manufacturer And User
Device Experience
13
MAUDE database of adverse events
Now click “Go to Simple Search”, then

type in “Xience Stent”, select 2015, and
search.
14
XIENCE Alpine Everolimus Eluting Coronary Stent System
http://www.abbottvascular.com/
15
MAUDE
Eventdatabase
Descriptionof adverse events
On 2014, a drug eluting coronary device was

implanted in the 1) distal LAD, 2) mid LAD, 3) proximal
left circumflex coronary artery lesion. ….
On 2014, the patient was admitted to the hospital. Per

coronary angiogram, there was a 80% re-stenosis in 1)
distal LAD, 2) mid LAD and 40% stenosis in 3)
proximal left circumflex coronary artery lesion.
As treatment, 4 new xience xpedition’s were

implanted.
16
Exercise - Homework
• Identify 3 medical devices you’re familiar with or interested in; 1 from each of the 3 classifications (read
through
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm
to see how the identify classification works)
• Find each device’s classification and product code
• Find at least one adverse event associated with each device and read about the event
• Write a brief summary (approximately 1 page, single spaced, 12 pt Times New Roman, 1” margins) of what
you found (include the report numbers from the MAUDE database so the grader can find the same adverse
events) in the event and on the background of the devices.
• One great place to find background on devices is in the official instructions for use (IFU) of the device,
particularly for class II and III devices. For the Xience Alpine system, find the drug dose density for +5 points
and note the value and source at the end of your report.
• Include your name, section, date, and a title at the top of your report. Your file name should be like
“HW1_MedDevRep_JaneSmith.pdf” and submit via eLearning.

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MEDICAL DEVICE REGULATION

An Introduction to the Basics

Regulation is country specific

Regulation is country specific

• Japan has the JFDA – similar to US FDA.

• China and some other countries rely primarily on

US FDA’s Medical Device regulations

What is a medical device?

• diagnoses, cures, lessens, treats, or prevents human

3 classes of medical devices (I, II, and III)

Risk to user (patient) increases as

Class I – 47% of medical devices

Class II – 43% of medical devices

Class III – 10% of medical devices

• Have the toughest regulatory controls.

• Examples: pacemakers, implanted weight loss devices,

FDA tracks adverse events (device-associated deaths, serious

• Data stored in something called the MAUDE database

• Useful for understanding common device failures within a

• What might be wrong with making decisions based on this

MAUDE database of adverse events

MAUDE database of adverse events

Now click “Go to Simple Search”, then

XIENCE Alpine Everolimus Eluting Coronary Stent System

On 2014, a drug eluting coronary device was

On 2014, the patient was admitted to the hospital. Per

As treatment, 4 new xience xpedition’s were

• Find each device’s classification and product code

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