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A submission to the FDA for premarket notification regarding the Vitascore polysomnography scoring software, including details on its intended use and regulatory compliance.

How to fill out vitascore 510k premarket notification

How to fill out Vitascore (510(k)) Premarket Notification

1. Gather all necessary documentation and materials required for the Vitascore (510(k)) submission.
2. Identify the predicate device that you will be comparing your device against.
3. Fill out the cover sheet, including the name, address, and contact information of the submitter.
4. Complete the Administrative Information section, including device names and intended use.
5. Provide a detailed description of the device, including its components and functioning.
6. Prepare the substantial equivalence section by explaining how your device is similar to the predicate device.
7. Include labeling information, such as instructions for use, packaging, and promotional materials.
8. Submit any performance testing or clinical data that supports the device's safety and effectiveness.
9. Review the entire submission for accuracy and completeness before finalizing it.
10. Submit the Vitascore (510(k)) application electronically or via mail to the FDA.

Who needs Vitascore (510(k)) Premarket Notification?

1. Manufacturers seeking to market a new medical device that is substantially equivalent to a legally marketed device.
2. Companies wishing to introduce devices that require FDA clearance prior to commercialization.
3. Organizations looking to ensure compliance with FDA regulations for medical device marketing.

People Also Ask about

What is premarket notification 510k?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

How long does it take for the 510 K determination in the case of traditional premarket notification?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is the meaning of premarket approval?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

What is an exemption from the 510k premarket notification requirements?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

What are the three types of 510k?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What is a 510k premarket notification?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

What is an exemption from the 510k premarket notification requirements?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

For pdfFiller’s FAQs

What is Vitascore (510(k)) Premarket Notification?

Vitascore (510(k)) Premarket Notification is a submission to the FDA that demonstrates that a medical device is safe and effective, and is substantially equivalent to a device already legally marketed.

Who is required to file Vitascore (510(k)) Premarket Notification?

Manufacturers of medical devices that are not exempt from premarket review must file a 510(k) Premarket Notification to the FDA before marketing their device.

How to fill out Vitascore (510(k)) Premarket Notification?

To fill out the Vitascore 510(k) application, manufacturers must gather required information about the device, including descriptions, intended use, labeling, and performance testing data, and complete the FDA's 510(k) submission forms.

What is the purpose of Vitascore (510(k)) Premarket Notification?

The purpose of the Vitascore (510(k)) Premarket Notification is to provide the FDA with sufficient information to determine whether the device is safe and effective for its intended use and whether it is substantially equivalent to an already marketed device.

What information must be reported on Vitascore (510(k)) Premarket Notification?

The Vitascore (510(k)) Premarket Notification must include information such as device description, intended use, labeling, and results of performance testing, along with information about the predicate device to which it claims substantial equivalence.