All "Medical Devices" articles

4 Reasons Overhauling FDA 510(k) is a Great Move

Recent high-profile failures of medical devices have caused harm and injury to patients while damaging the FDA and medical device industry's ...

The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance

In 2017, the FDA issued 218 more warning letters for 21 CFR 820 than they did the previous year. The 21 CFR 820 regulation, which the FDA uses to ...

How to Clear the 21 CFR 820.50 Hurdle in 7 Easy Steps

In 2017, the FDA cited 3,515 observations for 21 CFR 820 and sent 138 warning letter citations for 21 CFR 820.50. That means that somewhere during ...

9 Ways to Ensure Medical Product Compliance Through Quality

In our work with medical device product developers and manufacturers, we know quite well the stress that comes with scrutiny of regulatory ...

FDA issues draft updated recommendations on submitting a new 510(k) for device modifications

Interesting news coming out of the FDA today, where the agency released a rule that amends its regulations on the definition of a custom device so as ...

FDA Provides Wellness Device Testing Guidelines. What's Your Next Move?

Last month, the US Food and Drug Administration (FDA) released a document that provides guidelines and compliance information for companies that ...
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