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.
Looking to register your medical device in the United States? Contact us today!