Get the free 21 CFR Part 860 -- Medical Device Classification Procedures
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SectionField Name regulation_numberType stringDescription The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified
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How to fill out 21 cfr part 860
How to fill out 21 cfr part 860
01
Review the purpose of 21 CFR Part 860, which outlines the requirements for the classification of medical devices.
02
Identify the product category that applies to your medical device.
03
Gather necessary information about your device, including its intended use, indications for use, and any relevant scientific data.
04
Determine the classification regulation that corresponds to your device according to the device classification system.
05
Complete the form or template provided by the FDA, ensuring all sections are filled out accurately.
06
Submit your completed classification request to the FDA, following the submission guidelines outlined in the regulations.
07
Respond to any additional requests for information from the FDA during the review process.
Who needs 21 cfr part 860?
01
Manufacturers of medical devices seeking to understand the classification requirements for their products.
02
Regulatory affairs professionals involved in the submission and maintenance of medical device registrations.
03
Healthcare providers and institutions that need information about the regulatory status of devices they use.
04
Legal experts and consultants working with medical device companies.
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What is 21 cfr part 860?
21 CFR Part 860 outlines the criteria for classification of medical devices and the process by which the Food and Drug Administration (FDA) evaluates these devices.
Who is required to file 21 cfr part 860?
Manufacturers and developers of medical devices are required to file information under 21 CFR Part 860 to classify their devices and ensure regulatory compliance.
How to fill out 21 cfr part 860?
Filling out 21 CFR Part 860 involves submitting a detailed classification request that includes device description, intended use, and information on safety and effectiveness.
What is the purpose of 21 cfr part 860?
The purpose of 21 CFR Part 860 is to provide a regulatory framework for the classification and evaluation of medical devices to ensure they meet safety and effectiveness standards.
What information must be reported on 21 cfr part 860?
Information required includes device name, classification, intended use, details of any studies conducted, and any pertinent safety and effectiveness data.
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