The Top 10 Do’s and Don’ts When Undergoing an FDA Inspection (MedTech Download)

Kelly Springs-Kelley
January 06, 2021

Key Takeaways

  • When it comes to an FDA inspection, there are things you can do – and things you can avoid – to achieve a better result for your company.
  • Point-of-care diagnostics have gotten a boost from the post-pandemic world. Experts are weighing in on both opportunities and challenges for the industry as we move into 2021.
  • In 2020, infusion pumps appeared most frequently on the FDA’s recall list. But, this is not uncommon, as the devices are widely used across the medical system.

FDA 2020 Recall Roundup: A Rough Year for Infusion Pumps

FDA inspections and recalls

As technology advances, so too does the development and adoption of new medical devices. And while receiving FDA approval is standard protocol for the majority of MedTech, that green light doesn’t guarantee smooth sailing once the device gets into the hands of users. In fact, “on average, about 4,500 drugs and devices are pulled from U.S. shelves each year.” 

Last month the FDA published its 2020 recall roundup, and MedTech Dive reported that infusion pumps appeared most frequently. The article said that “while the number of Class I recalls involving infusion pumps is higher than in previous years, the devices in general tend to make the list annually.” It went on to explain that this is in large part due to the wide use of these devices in hospitals.

AACC 2020: COVID-19 Paved Way For ‘Retailization,’ Innovation In Point-Of-Care Testing, Now What?

Last year, Jaunt developed an analysis of the point-of-care diagnostics market, uncovering that the sector has grown rapidly year-over-year. In fact, we reported that “In 2018, the global market was valued at $22.3 billion, with POC diagnostic sales projected to grow at a compound annual growth rate of 5.9% from 2019 to 2024.” There are several reasons for this growth, including technological advancements, expanding indications for use, the increasing burden of disease, and increased patient accessibility. 

Now that 2020 has come and gone, there is one more clear reason why POC has boomed. As MedTech Insight puts it, “the pandemic has ushered in a new era in point-of-care (POC) testing in which technologies are increasingly becoming more accessible, more affordable and more convenient, putting the consumers’ needs first.” The article covers a recent panel discussion in which experts debated POC’s opportunities and challenges.

The 10 Best – And 10 Worst – Things You Can Do During an FDA Inspection

Dos and donts during an FDA inspection.

While FDA recall is high on the avoidance list for MedTech manufacturers, so too is a poor FDA inspection. And while the pandemic has slowed and challenged the FDA when it comes to conducting in-person checks, they are still taking place. In fact, the FDA is currently designing virtual workarounds that will allow them to continue their work.

MedTech Insight recently published an article authored by several industry experts, including David Elder, executive VP for consulting firm Greenleaf Health and former director of the FDA’s Office of Regional Operations within the Office of Regulatory Affairs (ORA). The panel offers 10 of the best and worst things companies can do when it comes to FDA site inspections, demonstrating how companies can be better prepared to achieve a positive outcome.

Taking the Guesswork Out of Tracking High Blood Pressure

In the diabetes world, the technology behind blood sugar monitoring has evolved quickly. It wasn’t until the 1980s that home blood glucose tests became commonplace. Since then, continuous glucose monitors, complete with smartphone apps, automated alerts, and predictive algorithms have become a new norm in care, significantly improving patient safety and quality of life. 

Like diabetes, those suffering from cardiovascular disease also benefit from consistent monitoring. In both cases, the variability in both blood pressure and blood sugar can be dramatic, so occasional monitoring still leaves patients vulnerable to the repercussions associated with dangerous swings. However, unlike diabetes, continuous monitoring for hypertension has not been available – until now. Aimee Garza of MedTech startup CoraVie Medical is creating an implantable, continuous blood pressure monitor that can notify physicians if a patient has abnormal readings.

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