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Topic: Premarket Requirements of FDA and

European Union

Presented To: Namra Afzal

Presented By: Minahil Ijaz ( 2019-BME-14)

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Premarket requirements in FDA

Four steps to bring a device to the market:

• Step One: Classify Your Device

• Step Two: Prepare the Correct Premarket Submission

• Step Three: Send your Premarket Submission to the FDA

• Step Four: Comply with Applicable Regulatory Controls

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Step 1: How to Classify Your Device?
●
REGULATORY
●
CLASS ●
RISK ●
POTENTIAL HARM ●
SUBMISSION TYPE
CONTROLS
●
510(k)
●
I ●
lowest ●
Present minimal potential for harm ● General controls ● 510(k)
exempted
●
510(k)
●
General controls
●
II ●
moderate ● Higher risk than class I ●
510(k)
●
Special controls
exempted
Sustain or support life PMA
General controls
Implanted devices HDE
●
III ●
highest Special controls
Present potential unreasonable risk Denovo request
of illness or injury. PMA
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STEP 2: Prepare Premarket Submission

The most common types of premarket submissions include:

1. 510(k) (Premarket Notification)

2. PMA (Premarket Approval)

3. De Novo Classification Request

4. HDE (Humanitarian Device Exemption)

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510(k) Submission Is device substantially
equivalent to predicate
device?
In case of class I and II, the new
NO YES
device is "substantially equivalent"
to a predicate device in terms of:
510K exempted Submit 510K
• intended use
• technological characteristics,
• performance testing, as needed.
Clearance to market
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PMA Premarket approval
• De Novo Classification Request
The
• Class III devices De Novo
require process
a PMA. provides
Before theaFDA
pathway to classify
approves novelthe
a PMA, medical devices
sponsor mustforprovide
which general
valid controls alone,
or generaldemonstrating
scientific evidence and special controls, provideassurances
reasonable reasonable assurance
of safetyof and
safetyeffectiveness
and effectiveness
for for
thethe intended use,
but foruse.
device’s intended which there is no legally marketed predicate device.

• This requires the company to apply for an Investigational Device Exemption (IDE) from the FDA.
Once the IDE is obtained, device is approved by FDA.

Humanitarian device exemption

• HDE provides a regulatory pathway for class III devices that are intended to benefit patients with
rare diseases or conditions
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De novo Request submission

Class III PMA

High
risk? Not de
No novo
predicate Low to Medium risk? device
New available
device De novo
device
Predicate 510k
available submission
 Step 4: Regulatory controls 08

Devices in all three classes (Class I, II, and III) are subject to general controls

1. General controls

501 510 Device 516 Banned 519 Records and

Adulteration registration devices reports

502 520 Restricted

misbranding devices

510 Premarket notification 518 Notification, repair, replacement

and refund
 C Special controls omply with
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Applicable Regulatory Controls
Performanc
Special Controls as specific e standards

guidance for Class II devices. Patient Post market

registries surveillance
Additional controls are expected to
“provide reasonable assurance of the
Special
safety and effectiveness” when there
controls Premarket
data
Guidelines requirements
is insufficient evidence to establish
Special
labeling
general controls. requirements
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 FDA REGULATORY PATHWAY
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Lowest risk? Moderate risk?
Class I Class II
Highest risk?
Is device substantially equivalent Class III
to predicate device?

NO YES PMA
HDE
Premarket approval
510 k 510K For rare
For reasonable
exempted Submission diseases
safety

Require general Require both general and special controls

controls only

Device introduced in the market

Premarket requirements in European CE 11
Premarket requirements in European union

Step 1: Determine which EU Medical Device Directives

• In Vitro Diagnostic Medical Devices (IVDMD)
• Medical Devices (MDD)
• Active Implantable Medical Devices (AIMDD)
Step 2: Determine classification:
• Class I (non-sterile, non-measuring),
• Class I (sterile, measuring)
• Class IIa
• Class IIb
• Class III/AIMD.
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Step 3:
Implement Quality Management System (QMS)
Step 4:
• For Classes I, IIa, IIb prepare a Technical File
• For Class III/AIMD devices prepare a Design Dossier.
Step 5:
If you do not have a location in Europe, appoint an Authorized
Representative located in Europe. The representative should be qualified to
handle regulatory issues.
Step 6:
Technical File or Design Dossier must be audited by a Notified Body
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Step 7:
For all devices except Class I (non-sterile, non-measuring), you will be issued a
European CE Marking Certificate for your device and an ISO 13485 certificate.
Step 8:
Prepare a Declaration of Conformity, a legally binding document prepared by
the manufacturer stating that the device is in compliance with the applicable
Directive
Step 9:
All devices must be registered with the Competent Authority
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EU medical device Manufacturer Determine device regulations and directives
Regulatory Pathway
Class I: sterile and measuring, class II a,
Determine classification class II b, class III

Class I :non-sterile and non measuring Quality management system

Prepare technical file for class I, IIa, IIb Prepare design dossier for class III

No Quality management appoint an Authorized Representative located in Europe

system required only PMS
required
Prepare technical file Technical File or Design Dossier must be audited by a Notified Body

European CE Marking Certificate

Declaration of conformity

Device registered
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ANY QUESTIONS?