The timeline for FDA registration can vary depending on the type of product and the specific registration or approval process. Below is an overview of typical timelines:

1. FDA Establishment Registration (Medical Devices, Drugs, and Food Facilities):

• Medical Devices:
  • FDA establishment registration for medical devices is generally valid for one year and must be renewed annually. The registration itself is a relatively quick process and can typically be completed within a few weeks if all required information is provided.
• Drugs:
  • Drug establishment registration is also an annual process, and the initial registration can be completed in a few weeks. However, more complex drug approval processes (e.g., New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA)) can take several months to years depending on the complexity of the drug and the review process.
• Food Facilities:
  • For food facilities, registration is generally quick and can be completed online. However, like other FDA registrations, it needs to be renewed every two years.

2. FDA 510(k) Premarket Notification (Medical Devices):

• 510(k) Submission Process:
  • The FDA review of a 510(k) submission typically takes 3 to 6 months, but it can take longer if additional information or testing is required. The timeline depends on the completeness of the submission and the complexity of the device.
  • After the FDA clears the device, the manufacturer must maintain its registration and keep the device listing up to date.

3. Premarket Approval (PMA) for Medical Devices:

• PMA Process:
  • The FDA’s review of a PMA submission is a much longer process and can take 1 to 3 years, depending on the complexity of the device and whether additional clinical data is required.
  • The timeline can be affected by the type of review (e.g., standard or expedited), the need for inspections, and the completeness of the application.

4. New Drug Application (NDA) and Abbreviated NDA (ANDAs):

• NDA Review Process:
  • The NDA process typically takes about 10 to 12 months for the FDA to review, but can be longer if the FDA requires additional clinical trials or information. Priority review or fast-track designations may reduce the timeline to around 6 months.
• ANDA Review Process:
  • ANDA submissions generally take 12 to 18 months for FDA review, but this timeline can vary based on the complexity of the generic drug being reviewed.

5. FDA Registration for Food and Dietary Supplements:

• For food products and dietary supplements, FDA registration is primarily focused on facility registration and product listing, which typically takes a few days to a few weeks. However, the FDA does not approve individual food products before they are marketed (except for certain claims or ingredients), so the registration process is generally quicker than for drugs or medical devices.

6. Other FDA Certificates (e.g., Export Certificates, CFSAN):

• Export Certificates: These are usually processed within a few weeks to months, depending on the complexity and completeness of the request.

Overall, while initial FDA registration (such as establishment registration) can be done relatively quickly (within a few weeks), more complex approval processes (like 510(k) or PMA for medical devices or NDA for drugs) can take anywhere from several months to years. The timeline can also vary based on the completeness of the submission, the type of product, and the FDA’s workload.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn