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FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.

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,…

New Imaging Drug for Ovarian Cancer

New Imaging Drug for Ovarian Cancer

In November of 2021, the Food and Drug Administration (FDA) approved Cytalux. Cytalux is a new imaging drug intended to assist surgeons with the identification of ovarian cancer lesions1. This new drug was designed to assist in locating additional ovarian cancer tissues that can be…

Software as a Medical Device

Software as a Medical Device

Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is….

Decorative Contact Lenses

Decorative Contact Lenses

Decorative contact lenses are a known medical device and are treated with the same standards as corrective contact lenses. Decorative lenses are also known as

Water for Pharmaceutical Use

Water for Pharmaceutical Use

When determining which type of water system is needed for pharmaceutical manufacturing it is important to keep in mind how the water will be applied to the product.

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