FDA Posts

SOPs: What You Need to Know

Mark Crawford

According to the FDA, the problem cited in 60 percent of all warning letters is SOP—standard operating procedures.

That’s actually a good thing because it is relatively straightforward (but not always easy) to fix SOPs. Identifying them is one thing—they also need to be concise, clearly written, well-communicated, monitored, and enforced. Taking the time to meet or exceed FDA SOP expectations will not only bring you into compliance but also improve operations and productivity in every department—leading to higher quality, improved profits, lower costs, faster delivery to market, and improved customer satisfaction. (more…)

Supply Chain Management Is a Big Target for the FDA

Mark Crawford

According to Alan Schwartz of mdi Consultants Inc., a former supervisor of field operations for the FDA, supply chain oversight is the FDA’s next big area of concern.

About a year ago the FDA indicated plans to expand its enforcement reach over foreign device suppliers through consent decrees. The FDA also asked manufacturers and importers to assume a bigger role in managing their supply chains. An FDA spokesperson, compliance officer Carmelo Rosa, further stated that “currently the agency only has authority to establish import alerts for foreign companies with good manufacturing practice violations, but is looking at other options.” (more…)

Mobile Medical Applications Are a Challenge for the FDA

Mark Crawford

In July 2011 the FDA released its draft guidance on the use of mobile medical applications. This first effort is regarded by many as long overdue; it also only addresses a restricted segment of the applications market. The comment period ended October 21 (view the guidance at Draft Guidance for Industry and Food and Drug Administration Staff–Mobile Medical Applications). (more…)

FDA and CMS Team up to Review Innovative Medical Devices

On October 7 the FDA and the Centers for Medicare & Medicaid Services (CMS) on announced a “parallel review” pilot program for reviewing medical devices for FDA approval and Medicare coverage.

Both organizations have agreed on guiding principles that are designed to streamline the processes and reduce the time span between marketing approval or clearance decisions and national coverage/payment determinations.

“By reducing the interval between FDA marketing approval and Medical coverage, this process will facilitate the development of innovative products and shorten the time it takes to bring these important products to patients,” states the FDA. (more…)

Will the Medical Device Regulatory Improvement Act Be a Game-Changer?

Mark Crawford

Three years ago the FDA enacted tougher measures to reduce the potential conflicts of interest for medical device experts advising the U.S. Food and Drug Administration (FDA).

Claiming that these rules are strangling the timely advance of new medical devices to the market, U.S. Senators Amy Klobuchar (D-Minnesota), Richard Burr (R-North Carolina), and Michael Bennet (D-Colorado) have introduced the “Medical Device Regulatory Improvement Act” in an effort to streamline the FDA regulatory process. (more…)

Root Cause Analysis and Human Factors

Mark Crawford

In its new white paper, “How to Reduce Human Error by Managing Human Factors,” the FDA indicates the “typical response to a human error is retraining. But studies have now shown that training —or lack thereof—is responsible for only about 10 percent of the human errors that occur. Despite [an increased] awareness of human errors, companies still frequently fail to substantively and correctly address errors.”

Companies often turn to training, or retraining, as a quick and easy solution for a human error, when the real cause may be a deeper, systemic issue that could be revealed through root cause analysis (RCA). (more…)

New Guidance on Postmarket Surveillance from the FDA

Mark Crawford

The FDA continues to roll out new guidance documents for medical device regulations—this time presenting updated rules for postmarket surveillance.
The draft entitled “Postmarket Surveillance under Section 522 of the Federal Food, Drug and Cosmetic Act,” released by the FDA on August 16, provides a summary of the revised postmarket surveillance program, including new modifications. (more…)

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.