What 21cfr 820?

21 CFR Part 820 is a set of regulations from FDA that outlines the current good manufacturing practice (CGMP) requirements that medical device manufacturers in the United States must follow with regards to their quality system.

What is the code in FDA?

An FDA product code describes a specific product and contains a combination of five to seven numbers and letters. The product code submitted with each FDA line item should match the actual product name and/or invoice description of the product.

What is FDA Class 2?

The FDA defines Class II devices as “devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.” Examples of Class II Medical Devices: Catheters. Blood Pressure Cuffs.

What goes into a DHF?

The DHF documentation must include identification of the design, methods of production, date, and individuals performing the validation. Design transfer: The process of transferring design into production, distribution, and installation specifications.

What is CGMPs?

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

What is FDA classification?

The FDA generally classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device’s safety and effectiveness. Devices are classified into one of three regulatory classes: class I, class II, or class III.

What are FDA device classes?

There are 3 classes of medical devices:

  • Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.
  • Class II devices are intermediate-risk devices.
  • Class III devices are high-risk devices that are very important to health or sustaining life.

What does FDA registered Class 1 mean?

Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.

What is FDA Class 2 performance?

FDA classifies into class II devices for which general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.

What is a DHR?

The FDA mandates that medical device companies produce a device history record (DHR) that contains all documentation related to manufacturing and tracking the device, and demonstrates that the device was manufactured according to the information in the device master record.

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