For FDA registration in the United States, the following regulations and compliance documents are typically required:

Regulations:

1. 21 CFR Part 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

   • Covers the registration of establishments and the listing of devices for manufacturers and importers.

2. 21 CFR Part 820 - Quality System Regulation (QSR)

   • Outlines requirements for the quality management systems that manufacturers must implement for medical devices.

3. 21 CFR Part 814 - Premarket Approval of Medical Devices

   • Details the process for premarket approval (PMA) of Class III medical devices.

4. 21 CFR Part 801 - Labeling

   • Provides requirements for the labeling of medical devices, including instructions and claims.

5. 21 CFR Part 312 - Investigational New Drug Application (IND)

   • Governs the process for conducting clinical trials for new drugs and biologics.

6. 21 CFR Part 314 - Applications for FDA Approval to Market a New Drug

   • Outlines the process for new drug applications (NDAs) and abbreviated new drug applications (ANDAs).

7. 21 CFR Part 606 - Current Good Manufacturing Practice for Blood and Blood Components

   • Specifies requirements for the manufacture of blood and blood components.

8. 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products

   • Covers the requirements for human cell and tissue products.

Compliance Documents:

1. Establishment Registration Form (FDA Form 2891)

   • Required for registering your facility with the FDA.

2. Device Listing Information

   • Details about the devices being listed, including product codes and descriptions.

3. Quality System Documentation

   • Documentation demonstrating compliance with the Quality System Regulation, including quality manuals, procedures, and records.

4. Premarket Submission Documents

   • Includes premarket notifications (510(k)), premarket approval applications (PMA), or other required premarket submissions.

5. Clinical Trial Data

   • For new drugs and biologics, clinical trial results and data supporting safety and efficacy.

6. Labeling Information

   • Detailed product labeling including instructions for use, warnings, and claims.

7. Good Manufacturing Practice (GMP) Compliance Documentation

   • Evidence that the manufacturing processes meet FDA's GMP standards.

8. Application Fees Payment

   • Proof of payment for application and registration fees.

Make sure to review the specific FDA regulations relevant to your product category and industry for any additional or specialized documentation that may be required.

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