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DEPARTMENT OF HEALTH and HUMAN SERVICES Public - FDA

DEPARTMENT OF HEALTH and HUMAN SERVICES Public - FDA 2025

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The document is a 510(k) summary for the Voyager Peritoneal Dialysis (PD) System, submitted by DEKA Research & Development Corporation. It outlines the device's intended use for automatic control of dialysate solution exchanges in adult renal failure patients undergoing peritoneal dialysis. The Voyager system is deemed substantially equivalent to predicate devices, including the HomeChoice Automated Personal Cycler and Fresenius Liberty Cycler. The document details the device's classification, testing results for safety and efficacy, and concludes that it meets all design requirements for market approval.

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What is the FDA equivalent for Canada?

Health Canada : Health Canada is responsible for protecting human and animal health and the safety of Canadas food supply.

How do you check if its FDA approved?

To find out if a drug is approved by FDA, consumers can use two different Internet sites: Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. The FDA Orange Book contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).

Who approves pharmaceuticals in Canada?

Regulatory approval Before a drug product is authorized for sale in Canada, the drug manufacturer must submit scientific evidence of the products safety, efficacy, and quality to Health Canada for review and approval.

What does the FDA do for the economy?

The Food and Drug Administration conducts objective economic analyses of all important proposed and final regulations, which includes the Regulatory Impact Analysis (RIA) as well as other analyses mandated by various statutes and executive orders.

What is the drug regulatory agency of Canada?

Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

Does the FDA apply in Canada?

Health Canada is the federal body that regulates the drug approval process under the Food and Drugs Act (FDA) and its regulations (FDR), its related policies and guidance.

What does the FDA stand for in Canada?

HTMLFull Document: Food and Drugs Act (Accessibility Buttons available) | XMLFull Document: Food and Drugs Act [275 KB] |

Who regulates food in Canada?

Health Canada establishes policies and standards governing the safety and nutritional quality of all food sold in Canada. They carry out food-borne disease surveillance for early detection and warning.

DEPARTMENT OF HEALTH and HUMAN SERVICES Public - FDA 2025

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