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Digital21 Pilot Program Spring 2020 Training Workshops College of SciencesThank you for your interest in the Digital21 pilot program. Please complete the information below and submit to cristina.villalobos@utrgv.edu

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How to fill out wwwfdagovmedical-devicesdigital-healthdigital health software precertification

01

Visit the FDA website at www.fda.gov

02

Navigate to the medical devices section

03

Select the digital health category

04

Click on the digital health software precertification link

05

Follow the instructions provided on the website to fill out the precertification form

Who needs wwwfdagovmedical-devicesdigital-healthdigital health software precertification?

01

Companies or individuals developing digital health software products that require precertification from the FDA

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What is wwwfdagovmedical-devicesdigital-healthdigital health software precertification?

The wwwfdagovmedical-devicesdigital-healthdigital health software precertification is a program established by the FDA to streamline the review process for digital health software. It aims to pre-certify companies that demonstrate a commitment to quality and excellence in software development.

Who is required to file wwwfdagovmedical-devicesdigital-healthdigital health software precertification?

Companies developing digital health software products are required to file for wwwfdagovmedical-devicesdigital-healthdigital health software precertification.

How to fill out wwwfdagovmedical-devicesdigital-healthdigital health software precertification?

The wwwfdagovmedical-devicesdigital-healthdigital health software precertification form can be filled out online on the FDA's website. Companies need to provide information about their software development processes, quality control measures, and previous products.

What is the purpose of wwwfdagovmedical-devicesdigital-healthdigital health software precertification?

The purpose of wwwfdagovmedical-devicesdigital-healthdigital health software precertification is to expedite the review process for digital health software products by pre-certifying companies that have demonstrated a commitment to quality and excellence.

What information must be reported on wwwfdagovmedical-devicesdigital-healthdigital health software precertification?

Information such as software development processes, quality control measures, previous products, and evidence of commitment to quality and excellence must be reported on wwwfdagovmedical-devicesdigital-healthdigital health software precertification.

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