Tools

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

Benefits of a QMS

Benefits of a QMS

Many companies do not understand the benefits of having a structured Quality Management System (QMS). A QMS is a system that documents procedures, processes, and responsibilities to achieve quality objectives and policies1. Quality management systems can be utilized in many industries especially the pharmaceutical and medical device industries, to provide structure for all processes at a facility.

What is a Fishbone Diagram?

What is a Fishbone Diagram?

A Fishbone diagram is a risk management tool used to visualize cause and effect to analyze the root cause of a product or quality problem in the pharmaceutical and medical device industry. The fishbone diagram is additionally known as the Ishikawa diagram, created by Kaoru Ishikawa in the 1940s.

When To Write A CAPA

When To Write A CAPA

A Corrective and Preventative Action (CAPA) is a tool utilized in order to address an issue or a potential issue with a product or process. According to the FDA “The purpose of the corrective and preventive action subsystem is to collect information,…

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