The Medpoint Blog

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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

5 Ways to Measure the Cost of Nonconformances

5 Ways to Measure the Cost of Nonconformances

How much does quality cost your company?  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

The Benefits of Using Life Sciences Consulting Firms Over Independent Consultants

The Benefits of Using Life Sciences Consulting Firms Over Independent Consultants

When contracting with external experts, you may be uncertain about whether to select a consulting firm or work with an individual consultant, i.e. a single-person LLC or sole proprietorship.  Read More

How to Compare Regulatory Consultants

How to Compare Regulatory Consultants

When it comes to ensuring compliance and avoiding FDA warning letters, regulatory affairs consultants are an excellent option. Choosing the right consultant can help your organization avoid compliance problems and improve the time-to-market for your product.   Read More

Management’s Role in Developing a cGMP-compliant QS

Management’s Role in Developing a cGMP-compliant QS

Creating an effective quality system (QS) requires a significant investment of time and resources. This requires more than just participation from staff. Management's involvement is key to setting up and maintaining a robust QS.  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

How to Optimize Your CAPA Escalation Process

How to Optimize Your CAPA Escalation Process

In 2020, the most common reason for FDA's 483 observation letters was "procedures for corrective and preventative actions have not been [adequately] established." (1)  Read More