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FDA Medical Device Approval Process
Step 1
Classify
Device
Class I
• Low risk to
moderate risk
• General controls
Class II
• Moderate to high
risk
• General and special
controls
Class III
• High risk
• General controls and
Premarket Approval
(PMA)
Step 2
Choose correct
premarket
submission
501(k)
• New device is
“substantially
equivalent” to a
predicate
PMA
• Valid scientific evidence
assuring safety and
effectiveness required
De Novo
• Classify new device
without predicate as
Class I or II
HDE (Humanitarian
Device Exemption)
• Class III device for
patients with rare
diseases or conditions
Source: U.S. Food and Drug Administration
Step 3
Prepare
appropriate
information
Step 4
Send premarket
submission and
meet with FDA
Design controls
• In accordance with
Quality System
Regulation
• Include user fee
associated with
510(k) or PMA
submission
Nonclinical testing
• Must comply with
Good Laboratory
Practices
• Complete
Establishment
Registration and
Device Listing
Clinical evidence
• May need to obtain
approval of an
Investigational
Device Exemption
(IDE)
Labeling
• Must be written
according to labeling
regulations
Device approved
Postmarket
requirements
• Include tracking
systems
• Report
malfunctions,
serious injuries
or deaths
• Register
establishments
where devices
are produced or
distributed