info@wiselink.com.au
1300 76 80 90
Medical Device Registration Services - United States
Regulatory Department
The Center for Devices and Radiological Health (CDRH) under the Food and Drug Administration (FDA)
Regulation
21 CFR Part 800-1299
Regulatory Classification & Registration Process
Class I – Lowest Risk
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510(k) Premarket Notification (Exemptions may apply)
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De Novo Classification Request required for novel medical devices
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Timeframe: 1 month
Class II
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510(k) Premarket Notification (Exemptions may apply)
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De Novo Classification Request required for novel medical devices
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Timeframe: 9-12 months
Class III – Highest Risk
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Premarket Approval Application (PMA)
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Humanitarian Device Exemption (HDE) may apply to certain humanitarian use medical devices
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Timeframe: >12 months
* An American representative is required to represent overseas medical device manufacturers. We will be able to manage this for you.
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Looking to register your medical device in the United States? Contact us today!
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