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DE B R DAIELOASOCAMENTOLEIRA DRDIODACADEPRTSICASBCCARDEICAEIGIINSUFICCIAOriginal ArticleENDADe Novo Versus Upgrade Cardiac Resynchronization Therapy in Patients with Heart Failure: A Cohort Study

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How to fill out de novo versus upgrade

01

Determine the purpose of the application (new project or upgrade).

02

For de novo: Gather all necessary documentation for a new application.

03

Complete the initial submission form with relevant project details.

04

Attach any required certifications and supporting documents.

05

For upgrade: Identify existing application details and required updates.

06

Fill out the upgrade form indicating the current application and changes needed.

07

Submit additional documentation that outlines the upgrade's impact.

Who needs de novo versus upgrade?

01

Startups or new businesses launching a product or service require de novo.

02

Companies looking to enhance or expand existing products should consider an upgrade.

03

Organizations that are introducing significant changes to a previously approved application need an upgrade.

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What is de novo versus upgrade?

De novo refers to a new application for a product that has not previously been approved or cleared, while an upgrade refers to modifications or improvements made to an existing product that is already on the market.

Who is required to file de novo versus upgrade?

Manufacturers seeking to introduce a new product that does not have a predicate device must file for de novo, whereas existing product manufacturers looking to enhance or improve their device must file for an upgrade.

How to fill out de novo versus upgrade?

For de novo, complete the De Novo Request form detailing the product's intended use and safety, while for upgrades, manufacturers must submit a 510(k) premarket notification indicating the changes made and demonstrating substantial equivalence to the predicate device.

What is the purpose of de novo versus upgrade?

The purpose of de novo is to provide a pathway for novel devices that do not have a predicate, ensuring they meet safety and effectiveness standards; the purpose of an upgrade is to allow existing devices to incorporate improvements while maintaining compliance.

What information must be reported on de novo versus upgrade?

For de novo, information about device design, intended use, clinical data, and risk analysis must be reported; for upgrade, data on the specific modifications, performance testing results, and labeling changes must be submitted.

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