To obtain FDA registration and certification in the United States, several conditions must be met depending on the type of product. Here’s an overview of key requirements for different categories:

1. Medical Devices:

   • 510(k) Notification:

     • Substantial Equivalence: The device must be substantially equivalent to an already legally marketed device.
     • Performance Testing: Provide evidence of safety and effectiveness through performance testing and/or clinical studies.
     • Labeling: Ensure that labeling meets FDA requirements, including instructions for use, indications, and warnings.
     • Quality System Regulation (QSR): Comply with FDA’s QSR, which includes design controls, manufacturing processes, and recordkeeping.

   • Premarket Approval (PMA):

     • Clinical Data: Provide clinical evidence demonstrating the safety and effectiveness of the device.
     • Manufacturing Information: Submit detailed information on manufacturing processes and facilities.
     • Labeling: Meet FDA labeling requirements.
     • Quality System Regulation (QSR): Adhere to QSR standards.

   • De Novo Classification:

     • Novel Device Evidence: Demonstrate that the device is novel and does not have a substantially equivalent device.
     • Safety and Effectiveness: Provide data supporting the safety and effectiveness of the device.
     • Labeling: Ensure that labeling complies with FDA standards.
     • Quality System Regulation (QSR): Comply with QSR requirements.

2. Drugs:

   • New Drug Application (NDA):

     • Clinical Trials: Submit data from clinical trials demonstrating the drug's safety and efficacy.
     • Manufacturing Information: Provide details on manufacturing practices, controls, and facilities.
     • Labeling: Ensure that the drug labeling is accurate and complies with FDA requirements.
     • Good Manufacturing Practices (GMP): Adhere to GMP regulations.

   • Abbreviated New Drug Application (ANDA):

     • Bioequivalence Data: Demonstrate that the generic drug is equivalent to the branded drug in terms of safety, efficacy, and quality.
     • Manufacturing Information: Provide information on manufacturing processes.
     • Labeling: Meet FDA labeling requirements.
     • Good Manufacturing Practices (GMP): Comply with GMP regulations.

3. Biologics:

   • Biologics License Application (BLA):
     • Clinical Data: Submit data showing the safety and efficacy of the biologic.
     • Manufacturing Information: Provide detailed manufacturing processes and controls.
     • Labeling: Ensure labeling meets FDA requirements.
     • Good Manufacturing Practices (GMP): Adhere to GMP standards.

4. Food Products:

   • Generally Recognized as Safe (GRAS) Notification:
     • Safety Data: Provide evidence that the substance is safe for its intended use.
     • Labeling: Ensure that labeling complies with FDA requirements if applicable.
     • Compliance: Follow any relevant FDA regulations for food safety and manufacturing.

In all cases, submissions must be complete, accurate, and in compliance with FDA regulations. Maintaining clear and ongoing communication with the FDA throughout the process can also be crucial for meeting requirements and addressing any issues that arise.

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