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Learn best practices and gain new insights on quality assurance, regulatory strategy, and clinical affairs.
Why the FDA Withdrew Dozens of Proposed 510(k) Exemptions

Why the FDA Withdrew Dozens of Proposed 510(k) Exemptions

In March and April 2020, the Food and Drug Administration (FDA) issued guidance aimed at expanding the availability of certain medical devices that were critical in fighting COVID-19, such as ventilators, respiratory devices, sterilizers, disinfectants devices, air purifiers, gowns, hoods, and gloves. The guidance, which would remain in effect only for the duration of the pandemic public... Read More

FDA Remote Interactive Evaluations Part 2: What to Expect

FDA Remote Interactive Evaluations Part 2: What to Expect

Due to the limitations inflicted by the pandemic, Remote Interactive Evaluations (RIEs) are becoming an important part of regulatory decision-making. Specifically, the FDA is using RIEs to limit unnecessary contact.   Read More

FDA Remote Interactive Evaluations Part 1: What You Need to Know

FDA Remote Interactive Evaluations Part 1: What You Need to Know

Since the start of the COVID-19 pandemic, the FDA has had to adjust its approach to in-person inspections. The agency is now taking advantage of the available technologies to maintain high-level regulatory oversight remotely.  Read More

Why AI Poses a Problem for Traditional Regulatory Pathways

Why AI Poses a Problem for Traditional Regulatory Pathways

The medical device industry is already feeling the effects of the Artificial Intelligence (AI) revolution. However, most advanced AI algorithms are not well-suited for the current regulatory landscape. Fortunately, the FDA has released an action plan on how they plan to handle the challenges brought on by AI/ML-based software for medical devices.  Read More

5 Labeling Changes that Require a New 510(k)

5 Labeling Changes that Require a New 510(k)

Medical device labeling changes are made for a wide array of reasons. When a manufacturer makes changes to the labeling for a medical device, they must assess the impact of the change against their 510(k) clearance.  Some changes may require a new 510(k) submission.  Others don't require a new 510(k) submission but will require thorough documentation of the changes.   Read More

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