The text is for the following question. Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21 - Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299. Bringing a device to the market in the United States may appear complex. Following these four steps may assist you to navigate the process. Step one: Classify your device and understand applicable regulatory controls. The first step in preparing a device for marketing in the United States is to determine how the FDA has classified your device. Step two: Select and prepare the correct premarket submission. For most medical devices, the appropriate submission type is identified within the product classification, which may be obtained from the public Product Classification database. Step three: Prepare the appropriate information for the premarket submission. Once you have prepared the appropriate premarket submission for your device, you need to send your submission to the FDA and interact with FDA staff during its review. Step four: Comply with applicable regulatory controls, including the establishment registration and device listing. Regulatory controls are risk-based requirements that apply to medical devices and give FDA the oversight to ensure the reasonable safety and effectiveness of medical devices. (fda.gov. 2020. “How to Study and Market Your Device”. Accessed on 5 April 2020. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device) Which of the following statements agrees with the information given in thepassage?

Question

The text is for the following question.

Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21 - Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299. Bringing a device to the market in the United States may appear complex. Following these four steps may assist you to navigate the process.

Step one: Classify your device and understand applicable regulatory controls.

The first step in preparing a device for marketing in the United States is to determine how the FDA has classified your device.

Step two: Select and prepare the correct premarket submission.

For most medical devices, the appropriate submission type is identified within the product classification, which may be obtained from the public Product Classification database.

Step three: Prepare the appropriate information for the premarket submission.

Once you have prepared the appropriate premarket submission for your device, you need to send your submission to the FDA and interact with FDA staff during its review.

Step four: Comply with applicable regulatory controls, including the establishment registration and device listing.

Regulatory controls are risk-based requirements that apply to medical devices and give FDA the oversight to ensure the reasonable safety and effectiveness of medical devices.

(fda.gov. 2020. “How to Study and Market Your Device”. Accessed on 5 April 2020. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device)

Which of the following statements agrees with the information given in the passage? $\;\;\;$

Jawaban

jawaban yang benar adalah B.

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