The US FDA’s Case for Quality: What It Is and Why You Should Care

FDA's Case for QualityFor decades, the medical device industry has largely viewed the US Quality System Regulation (QSR) as a regulatory speedbump on the path to market access. Despite the regulation’s name, product quality has typically taken a back seat to regulatory compliance for manufacturers.

That’s understandable, since FDA’s inspection-oriented approach has rigorously emphasized compliance with specific aspects of 21 CFR Part 820. In recent years, FDA has had an epiphany of sorts. FDA inspectors had been seeing a high volume of the same issues year after year and, after talking with numerous industry stakeholders, FDA concluded that the regulations simply were not sufficient on their own to ensure high product quality and patient safety.…

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Yes it’s true – the US FDA is shifting toward ISO 13485. But how much and how soon?

Earlier this month, the US FDA officially announced their intention to shift toward international harmonization of the US Quality System Regulation (QSR). The medical device industry is likely to give a collective thumbs-up to the proposal, although its impact is unlikely to be felt anytime soon.

Known more formally as 21 CFR Part 820, the FDA QSR took effect in late 1978 and predates ISO 13485, which was introduced in 1996. The fact that FDA is nixing a regulation that has been around for nearly 40 years is FDA’s acknowledgment of three things:

  • The medical device industry – like many others – is a global business.
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FDA Proposes Expanding the List of 510(k)-Exempt Devices:
What You Need to Know

FDA List of 510k Exempt Medical Devices.

What: On March 14, 2017, FDA published a formal notice proposing to make hundreds of Class II medical devices exempt from premarket notification requirements that necessitate a 510(k) submission.* Note that there are a few exceptions for specific indications of medical devices. All devices will still need to meet other FDA requirements, such as 21 CFR 820 Quality System Requirements.

We view this shift as allowing FDA to focus its limited resources on higher-risk products in the 510(k) premarket notification pathway as well as the increasing number of 510(k) and de novo submissions being received.…

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