The Medpoint Blog

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Learn best practices and gain new insights on quality assurance, regulatory strategy, and clinical affairs.
What does the FDA Consider Data Integrity and Why Does It Matter

What does the FDA Consider Data Integrity and Why Does It Matter

For FDA (U.S. Food and Drug Administration)-regulated industries, organizations, and projects, the importance of data integrity is extremely high. Besides being a requirement for compliance reasons, data integrity is the foundation of a top-notch quality management system and paramount for ensuring patient safety.  Read More

The Importance of Picking the Right Predicate Device

The Importance of Picking the Right Predicate Device

Medical devices undergo a strict and rigorous evaluation by the Food & Drug Administration (FDA) to obtain approval for the US market. Suppose you want a Class II medical device cleared for sale in America. In that case, you need to be familiar with predicate devices (predicates) and how to support your substantial equivalency claims with carefully crafted documentation.  Read More

5 Regulatory Tactics to Improve 510(k) Clearance Results

5 Regulatory Tactics to Improve 510(k) Clearance Results

Your regulatory strategy determines whether your 510(k) submission clears the FDA or dies on the vine. It is the deciding factor in how long clearance takes: from 90 days to over six months. Lost months mean lost revenue and re-tasking resources that could be spent on other revenue-generating activities.  Read More

The Largest Medical Device Market in the World: Do You Need Help?

The United States of America is the largest medical device market in the world. A population’s age is a good indicator of how high the need for medical devices will be in the coming years. As the United States’ “Baby Boom” population(those born in the years 1946-1964) continues to age, the medical market is projected to steadily increase.  Read More

A Lesson in the Importance of Premarket Approval

Recently, the FDA ordered that all sales and distribution ofsurgical mesh for transvaginal repairs be stopped. Both companies still sellingthe mesh have 10 days to submit plans to remove the mesh from the market. Theruling is the latest in a series of FDA actions targeting the escalating safetyrisks associated with the mesh. The FDA’s order garnered mass attention nationwidein large part because... Read More

FDA Announces Changes to 510(k) Process

The last several years have brought many changes to the medical device quality and regulatory industries, and recent FDA announcements promise even more in the near future. As announced in late November 2018, there are significant updates planned for the 510(k) submission process, specifically related to the use of predicates.  Read More