The process for applying for FDA certification of Class I medical devices in the United States is generally straightforward due to their low-risk nature. Most Class I devices are subject to general controls rather than the more stringent premarket approval processes that apply to higher-risk devices. Here’s a step-by-step overview of the process:

1. Verify Device Classification

• Class I Classification: Confirm that your device falls under Class I by checking the FDA’s Device Classification Database. Most Class I devices are exempt from premarket notification requirements (510(k)), but you should verify this for your specific product.
• FDA Regulations: Review the specific regulatory requirements for your device category to ensure compliance with applicable standards.

2. Register the Establishment with the FDA

• FDA Registration: Manufacturers of Class I devices must register their establishment with the FDA before they can market their device in the U.S.
• Registration is completed through the FDA’s Unified Registration and Listing System (FURLS).
• Annual Renewal: Registration must be renewed each year, and an annual fee may apply, depending on the size and type of your business.

3. List the Device with the FDA

• After registering the establishment, you must list the device with the FDA in the Device Registration and Listing section of FURLS.
• The device listing includes basic information about the device, such as its intended use and classification.
• No 510(k) Notification: Most Class I devices are exempt from the 510(k) premarket notification requirement unless they are subject to specific regulations.

4. Comply with FDA General Controls

Even though Class I devices don’t require premarket approval or 510(k) submission, they must meet the FDA’s general controls, which include:

• Quality System Regulations (QSR): Compliance with 21 CFR Part 820 to establish and maintain a quality management system (QMS) for manufacturing.
• Labeling: Devices must meet FDA labeling requirements under 21 CFR Part 801, which include providing clear, accurate instructions and safety warnings.
• Medical Device Reporting (MDR): Manufacturers are required to report adverse events or defects associated with their device as per 21 CFR Part 803.
• Manufacturing Facility Inspections: The FDA may conduct inspections to ensure compliance with QSR and other regulations.

5. Post-Market Surveillance

• Monitoring: Once the device is marketed, the manufacturer must ensure the device remains safe and effective. This involves:
  • Monitoring for adverse events and complaints.
  • Reporting incidents and recalls as necessary.
• Device Recalls: If defects are identified or the device poses a risk to public health, the manufacturer must cooperate with the FDA in recalling the device.

6. Annual Registration Renewal

• Renewal: The establishment registration must be renewed annually. Manufacturers must ensure that their device listing and registration are up to date with the FDA.

7. Device-Specific Requirements (if applicable)

• Exemptions and Special Cases: Some Class I devices are subject to special requirements, such as performance standards or labeling regulations. Review the specific regulations for your device category to determine if additional requirements apply.

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