August 2011 Posts

Take the Lead when It Comes to Compliance

Mark Crawford

Even though it’s easy to complain about regulatory agencies, without them things tend to get worse, not better (the financial industry, for example). There will always be companies that, when regulatory agencies aren’t looking over their shoulders, are tempted to slack off a bit, especially when the economy is tough, money is tight, and there are plenty of fires to put out.

So resist the temptation to slide (it’s always rough at the bottom). Be your own regulatory cop, whether you are being watched or not. Invest in whatever is necessary to fully understand compliance regulations, meet them, and even exceed them—for the simple reason that it is the best thing to do to protect yourself and your customers. (more…)

FDA Wants Four-Star Reviews

Mark Crawford

The FDA is tired of being the rate-determining step when it comes to the medical device approval process. In the field of chemistry, the rate-determining step is the slowest step in a chemical reaction—the reaction cannot go faster than the rate-determining step. To speed up their game, the FDA recently announced its medical device reviewers will undergo more extensive training, starting in September 2011.

The medical device review process of the FDA’s Center for Devices and Radiological Health (CDRH) has been heavily criticized over the years for being cumbersome and slow. A major factor in these complaints, especially for 510(k) and Premarket Approval Application (PMA) procedures, is high FDA reviewer turnover. (more…)

FDA Upgrades Human Factors and Usability Expectations

Mark Crawford

Less uncertainty from the FDA, and a smoother 510(k) submission process, is always a good thing. That’s why most medical device manufacturers (MDMs) support the new FDA guidance document released on June 22 that will improve the safety of medical devices by conducting more human factors engineering.

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Make Risk Work for You

Mark Crawford

Risk is everywhere—from the time you get up to the time you go to bed, and even while you sleep (earthquake, fire, carbon monoxide poisoning, sleep apnea, alien landing, etc.). The question always is: How much risk is tolerable, or reasonable? What kinds of risk need to be controlled the most? What is the cost benefit in doing so? Where is the trade-off? (more…)