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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 existing devices, such as 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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Click ‘Get Form’ to open the DEPARTMENT OF HEALTH and HUMAN SERVICES Public - FDA document in the editor.
Begin by filling out the applicant information section. Enter the name, telephone number, email, and date prepared for the contact person listed.
Proceed to the device description section. Clearly state the proprietary name, common/usual name, classification, device class, and product code as required.
In the indications for use section, specify that the Voyager Peritoneal Dialysis System is intended for adult renal failure patients undergoing peritoneal dialysis therapy.
Complete any additional sections regarding assessment of non-clinical data and clinical data as applicable. Ensure all fields are filled accurately.
Review your entries for accuracy before saving or exporting your completed form directly from our platform.

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What is the relationship between the FDA and the HHS?

The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.

What is the difference between HHS and FDA?

HHS has special subparts relating to vulnerable populations, e.g., children, prisoners, pregnant women, etc. FDA does not have comparable provisions for these populations. 5. The HHS regulations require assurances and certifications from the grantee institution.

Which department would the FDA be under?

The U.S. Food and Drug Administration is a federal regulatory agency in the Department of Health and Human Services.

Can HHS overrule FDA?

Further, the HHS Secretary generally has the authority to overrule decisions and recommendations of the FDA Commissioner and CDC Director, though this has happened only rarely in the past.

Is health and human services federal, state, or local?

The Department of Health and Human Services (HHS) is a sweeping federal department covering everything from health research, disease prevention, food and drug safety, and Medicare and Medicaid distribution.

Is the Department of health Human Services HHS is the only federal agency in the United States that contributes to the nations health?

The Department of Health and Human Services is the only entity under the federal government that plays a role in our nations health. False.

DEPARTMENT OF HEALTH and HUMAN SERVICES Public - FDA 2025

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