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This document summarizes the premarket notification for the safePICO arterial blood sampler, detailing its design, intended use, and comparability to predicate devices.

How to fill out 510k premarket notification k043143

How to fill out 510(k) Premarket Notification K043143; safePICO

1. Gather necessary information about your device and its intended use.
2. Identify the predicate device that is most similar to your device.
3. Prepare a cover letter that includes the submission details.
4. Complete the 510(k) application form provided by the FDA.
5. Include a detailed description of the device's design and specifications.
6. Provide performance testing data demonstrating substantial equivalence.
7. Include any labeling information that will accompany the device.
8. Submit the 510(k) application electronically or via mail as per FDA guidelines.
9. Pay the appropriate filing fee if applicable.
10. Await clearance from the FDA before marketing the device.

Who needs 510(k) Premarket Notification K043143; safePICO?

1. Manufacturers of medical devices that are similar to existing devices already on the market.
2. Companies looking to market a device intended for the same use as an existing device.
3. Organizations involved in producing modified or improved versions of existing devices.

People Also Ask about

What is the difference between premarket notification and 510k?

Premarket Approval (PMA) The PMA process is the most involved as scientific evidence, typically in the form of a clinical trial, is needed to prove the safety and effectiveness of your device. The FDA will either approve or reject the application within 180 days.

What is the difference between premarket notification and 510k?

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or

When to submit a 510 K premarket notification?

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 is an exemption from the 510k premarket notification requirements?

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 FDA premarket submission?

A 510(k) is a premarket notification (a type of US regulatory submission) made to FDA to demonstrate that the device to be marketed/distributed is at least as safe and effective (substantially equivalent) to a legally marketed device that is not subject to PMA.

What is premarket notification or 510 K?

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 FDA premarket number?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

What is an FDA premarket submission?

Pre-Submissions (Pre-Subs) The main purpose of the Pre-Sub Program (previously known as the Pre-IDE Program) is to provide the opportunity for a sponsor to obtain FDA feedback prior to an intended submission of an IDE or marketing application.

For pdfFiller’s FAQs

What is 510(k) Premarket Notification K043143; safePICO?

510(k) Premarket Notification K043143; safePICO is a regulatory submission to the FDA for medical devices, indicating that the device is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Premarket Notification K043143; safePICO?

Manufacturers or importers of the safePICO device who wish to market it in the United States must file the 510(k) Premarket Notification.

How to fill out 510(k) Premarket Notification K043143; safePICO?

Filling out the 510(k) requires providing information about the device, including its intended use, description, substantial equivalence to predicate devices, labeling, and performance testing results.

What is the purpose of 510(k) Premarket Notification K043143; safePICO?

The purpose of 510(k) is to demonstrate that the safePICO device is safe and effective for its intended use, ensuring compliance with FDA regulations.

What information must be reported on 510(k) Premarket Notification K043143; safePICO?

The 510(k) must report device identification, intended use, description of technology, labeling samples, summary of safety and effectiveness data, and any relevant performance testing results.