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The fees for FDA registration depend on the type of product and the specific registration or listing required. Below are some general fees related to FDA registration:

1. Medical Device Registration:

   • For medical devices, manufacturers must register their establishment with the FDA and list their devices.
   • FDA Establishment Registration: The registration itself is free for medical device manufacturers, but there is an annual user fee for certain device categories under the Medical Device User Fee Amendments (MDUFA).
   • MDUFA Fees: As of 2024, the user fees for medical devices vary depending on the type of submission (e.g., 510(k), PMA). For example:
     • 510(k) Submission Fee: Approximately $21,800 (this is the fee for submitting a 510(k) premarket notification).
     • PMA (Premarket Approval) Application Fee: Approximately $380,000 for a standard application (subject to changes annually).
     • Annual Establishment Registration Fee: There is a fee for establishments involved in the manufacturing of devices, which was about $5,500 in 2023. This fee is required annually.

2. Drug Registration:

   • Drug Establishment Registration: Registration fees for drug establishments under the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) can vary based on the manufacturer’s size and product types.
     • Annual Registration Fee for drug manufacturers was around $19,000 (for large manufacturers) in 2023.
     • Abbreviated New Drug Application (ANDA) or New Drug Application (NDA) fees also apply and vary depending on the application type.

3. Food Facility Registration:

   • Food Facility Registration: For food manufacturers, FDA registration fees are not required, but facilities must register with the FDA if they are involved in manufacturing, processing, packing, or holding food for consumption in the U.S.

4. Other FDA Registration Fees:

   • Cosmetic Products: Registration for cosmetics with the FDA is voluntary, and there is no fee.
   • Biological Products: There are separate registration fees for biologics, including vaccines and blood products, under the Public Health Service Act (PHS). The fees can be significant, often in the range of hundreds of thousands of dollars for product approvals.

The specific fee structure is updated annually, and it’s essential to check the latest fee schedule on the FDA’s website or consult with an FDA compliance expert to get the most accurate and up-to-date information.

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