To obtain FDA registration and certification in the USA, medical devices must meet several key requirements:
Device Classification:
- 510(k) Premarket Notification: For devices that are substantially equivalent to existing ones. Requires proving equivalence to a predicate device already on the market.
- Premarket Approval (PMA): For high-risk devices needing comprehensive clinical data to demonstrate safety and effectiveness.
Pre-market Submission:
- 510(k) Submission: Includes device description, intended use, and substantial equivalence data.
- PMA Submission: Requires detailed clinical studies, data on device performance, and evidence supporting safety and efficacy.
Quality System Regulations (QSR):
- Compliance with FDA’s Quality System Regulations (QSR) is necessary. This involves establishing and maintaining a quality management system for manufacturing and testing devices.
Labeling Requirements:
- Devices must meet FDA labeling requirements, including clear instructions for use, warnings, and device specifications.
Registration and Listing:
- Facilities must register with the FDA and list their devices. This involves submitting the necessary forms and paying applicable fees.
Compliance with FDA Standards:
- Devices must adhere to relevant FDA standards and guidelines, which can vary based on device type and risk class.
Post-market Surveillance:
- Ongoing reporting of adverse events and device performance is required once the device is on the market.
Meeting these requirements ensures that a device is approved for marketing and distribution in the U.S.
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