Get the free 510(k) u mr Summary This 510(k) summary information is being submitted in accordance...

MAY 15, 2014, K(133752 50k Section 7 1. 510(k) u Mr Summary This 510(k) summary information is being submitted in accordance with the requirements of SODA 1990 and 21 CFR 807.92. APPLICANT: Rosendo,

How to fill out 510k u mr summary

How to fill out a 510k UMR summary:

1. Gather all necessary information: Before starting to fill out the 510k UMR (User Medical Device Report) summary, make sure you have all the required details and documentation related to the medical device in question. This includes information such as device specifications, intended use, indications for use, manufacturing processes, and labeling.
2. Understand the regulatory requirements: Familiarize yourself with the regulations outlined by the Food and Drug Administration (FDA) for submitting a 510k UMR summary. Ensure that you have a clear understanding of the specific sections that need to be completed and the information that needs to be provided.
3. Start with device identification: Begin filling out the summary by providing detailed information about the medical device. This typically includes the device name, model or catalog number, manufacturer's contact information, and any unique identifiers associated with the device.
4. Describe the intended use: Clearly explain the purpose of the medical device and its intended use. This includes specifying the patient population that will benefit from using the device, the medical conditions it is designed to address, and any specific limitations or contraindications.
5. Provide a technical description: Describe the device's design and technical specifications in detail. Include information about its components, materials, dimensions, and any other relevant technical characteristics. In this section, you may also need to address any similarities to or differences from previously cleared devices in the market.
6. Demonstrate substantial equivalence: Compare your medical device with a legally marketed device(s) that is already cleared by the FDA. Highlight the similarities and explicitly state how your device is substantially equivalent to the predicate device(s) in terms of safety and effectiveness.
7. Detail the sterilization and biocompatibility: Explain the methods and processes used for device sterilization, ensuring that they are in compliance with FDA requirements. Additionally, provide information about the device's biocompatibility, including any testing performed and the results obtained.
8. Include any clinical data or performance testing: If you have conducted any clinical studies or performance testing demonstrating the safety and effectiveness of your device, include this information in the summary. Provide a detailed description of the methodology, study design, and results obtained.
9. Discuss labeling and packaging: Explain how the device is labeled, including the instructions for use, warnings, and precautions. Additionally, describe the device's packaging and provide any information regarding potential environmental impacts or disposal considerations.
10. Complete any applicable declarations: Depending on the specific device and its intended use, you may need to complete certain declarations, such as a declaration of conformity or a radiation safety report. Ensure that you accurately fill out and sign these declarations if required.

Who needs a 510k UMR summary:

1. Medical device manufacturers: It is primarily the responsibility of the medical device manufacturers to fill out the 510k UMR summary. This applies to companies or individuals seeking FDA clearance for their medical devices.
2. Regulatory affairs professionals: Regulatory affairs professionals who work within medical device companies are often responsible for preparing and submitting the required documentation to the FDA. They play a crucial role in ensuring compliance with regulations and gathering all the necessary information for completing the 510k UMR summary.
3. FDA reviewers: FDA reviewers, who assess the submitted 510k UMR summaries, need them to determine the substantial equivalence of the new medical device with previously cleared devices. They rely on the information provided in the summary to evaluate the safety and effectiveness of the device before granting clearance for marketing.

For pdfFiller’s FAQs

What is 510k u mr summary?

The 510k u mr summary is a summary of a medical device submission that demonstrates the safety and effectiveness of the device.

Who is required to file 510k u mr summary?

Medical device manufacturers or distributors who want to market a new medical device in the United States are required to file a 510k u mr summary.

How to fill out 510k u mr summary?

To fill out a 510k u mr summary, you must provide detailed information about the medical device, its intended use, any clinical data supporting its safety and effectiveness, and a comparison to a legally marketed device.

What is the purpose of 510k u mr summary?

The purpose of a 510k u mr summary is to demonstrate to the FDA that a new medical device is substantially equivalent to a legally marketed device and is safe and effective for its intended use.

What information must be reported on 510k u mr summary?

Information such as device description, intended use, preclinical and clinical data, labeling, and a comparison to a legally marketed device must be reported on a 510k u mr summary.

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