What type of PMA supplement is required when a new analyzer for total PSA testing is developed, with no changes to the technology?

What type of PMA supplement is required when a new analyzer for total PSA testing is developed, with no changes to the technology?

• A. Special PMA Supplements Changes Being Affected
• B. 30-day Notice
• C. Real Time Supplement
• D. 180-Day Supplement

Answer: (D)

When a new analyzer for total PSA testing is developed without changes to the underlying technology, the appropriate type of PMA supplement required is the 180-Day Supplement. This type of supplement is typically used for modifications that may not require extensive validation or clinical data, such as updates in label claims or changes in the manufacturing process that don't affect the device's intended use or safety and effectiveness. In the context of a new analyzer, if the technological basis remains unchanged, the 180-Day Supplement allows for the introduction of updates to labeling or packaging, among other modifications, while still adequately demonstrating that the product's safety and efficacy are preserved. This approach reflects the FDA's intention to streamline the process for devices that don't introduce significant new risks or changes.

When a new analyzer for total PSA testing is developed without changes to the underlying technology, the appropriate type of PMA supplement required is the 180-Day Supplement. This type of supplement is typically used for modifications that may not require extensive validation or clinical data, such as updates in label claims or changes in the manufacturing process that don't affect the device's intended use or safety and effectiveness.

In the context of a new analyzer, if the technological basis remains unchanged, the 180-Day Supplement allows for the introduction of updates to labeling or packaging, among other modifications, while still adequately demonstrating that the product's safety and efficacy are preserved. This approach reflects the FDA's intention to streamline the process for devices that don't introduce significant new risks or changes.