In the United States, a distributor cannot directly apply for FDA certification for a medical device. The FDA certification process is primarily the responsibility of the manufacturer of the device. However, distributors do play an important role in the FDA regulatory process, and there are certain steps they must take to comply with FDA regulations.

Here's the distinction:

1. Manufacturer’s Responsibility:

• FDA certification or approval is required for medical devices to be legally marketed in the United States. The manufacturer is the entity that applies for this certification or approval (either through 510(k) premarket notification or PMA for Class III devices).
• The manufacturer must provide all the necessary documentation, such as device descriptions, labeling, performance testing, and clinical data (for PMA) to the FDA for review.

2. Distributor’s Role:

• While distributors are not responsible for obtaining FDA approval or certification, they must comply with certain FDA regulations:
  • FDA Establishment Registration: Distributors may need to register their establishments with the FDA, especially if they are involved in the distribution of devices.
  • Device Listing: Distributors may need to ensure that the devices they sell are listed with the FDA by the manufacturer.
  • Compliance with Labeling Requirements: Distributors are responsible for ensuring that devices are labeled correctly, in accordance with FDA requirements, before they distribute them.
  • Handling Recalls: If there is a device recall, distributors are obligated to assist the manufacturer in managing the recall and notifying customers.

3. Importers:

• If the distributor is importing medical devices into the U.S., they must ensure that the devices meet FDA requirements and that the manufacturer has the necessary approvals. The importer often needs to provide a responsible official to the FDA and ensure that the devices are compliant before they are distributed.

4. Legal Manufacturer:

• The legal manufacturer is ultimately responsible for ensuring that the device meets FDA regulations, including premarket approval, manufacturing practices, and labeling.

In summary, while a distributor cannot apply for FDA certification directly, they are required to work with the manufacturer to ensure that the devices they distribute are FDA-approved or cleared, properly registered, and compliant with relevant regulations.

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