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Contains Nonbinding Recommendations Draft Not for ImplementationPostmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act Draft Guidance for Industry and Food and Drug

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Who needs postmarket surveillance under section?

1. Postmarket surveillance under section is typically required by manufacturers, distributors, or sellers of medical devices or pharmaceutical products.
2. Regulatory agencies and authorities may also require postmarket surveillance information from these entities to ensure the safety and effectiveness of the products in the market.
3. Healthcare professionals involved in the use or administration of medical devices or pharmaceutical products may also be interested in postmarket surveillance data for monitoring and reporting purposes.

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What is postmarket surveillance under section?

Postmarket surveillance under section refers to the monitoring and reporting of the safety and effectiveness of a medical device after it has been approved for market.

Who is required to file postmarket surveillance under section?

Manufacturers, importers, and device user facilities are required to file postmarket surveillance reports under section.

How to fill out postmarket surveillance under section?

Postmarket surveillance reports can be filled out electronically through the FDA's online reporting system or submitted via mail.

What is the purpose of postmarket surveillance under section?

The purpose of postmarket surveillance under section is to ensure the ongoing safety and effectiveness of medical devices on the market.

What information must be reported on postmarket surveillance under section?

Information such as adverse events, device malfunctions, and any changes to the device or its labeling must be reported on postmarket surveillance under section.