To obtain FDA registration and certification in the USA, several key requirements must be met, depending on the type of device and the regulatory pathway. Here’s an overview of the general requirements for both the 510(k) premarket notification and the Premarket Approval (PMA) process:

1. 510(k) Premarket Notification:

• Device Classification: The device must be classified into one of three categories: Class I, II, or III. Class I and II devices generally require a 510(k) submission, while Class III devices usually require a PMA.

• Substantial Equivalence: The device must be shown to be substantially equivalent to a legally marketed device (predicate device). This means it must have the same intended use and similar technological characteristics as the predicate device.

• Pre-Submission Requirements: Although not always required, engaging in a pre-submission meeting with the FDA can help clarify requirements and expectations.

• Documentation and Data: The application must include detailed documentation, such as device descriptions, labeling, performance data, and any other relevant information that demonstrates substantial equivalence.

• Testing and Standards: Provide evidence of compliance with relevant FDA-recognized standards, including performance testing and safety data.

• Quality System Regulations (QSR): Compliance with QSR (21 CFR Part 820) is required. This includes establishing and maintaining a quality management system for manufacturing the device.

• Fees: Pay the required user fees associated with the 510(k) submission.

2. Premarket Approval (PMA):

• High-Risk Classification: The device must be classified as Class III, which typically requires a PMA submission.

• Clinical Data: Submit comprehensive clinical data demonstrating the safety and effectiveness of the device. This may include results from clinical trials.

• Pre-Submission Requirements: A pre-submission meeting with the FDA is highly recommended to discuss the data requirements and review process.

• Documentation: The PMA application must include detailed documentation such as device descriptions, manufacturing processes, clinical study protocols and results, labeling, and any other pertinent information.

• Quality System Regulations (QSR): Similar to the 510(k) pathway, compliance with QSR is necessary for PMA submissions.

• Fees: Pay the required user fees associated with the PMA process.

• FDA Review: The FDA will review the submission, which may involve additional requests for information or modifications before approval.

In both cases, it is crucial to ensure that all submissions are complete, accurate, and meet the FDA’s regulatory requirements. Engaging with the FDA early in the process through pre-submission meetings can help address any potential issues and streamline the approval process.

Contact Us：

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