2011 Posts

SOPs: What You Need to Know

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

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…)

Medical Technology Is Hot in Germany

Medical Technology Is Hot in Germany

Mark Crawford

There is no question that Germany is one of the most prosperous countries in the EU—especially when it comes to medical technology products. According to Germany Trade and Invest, Germany ranks third in the world for medical technology behind the U.S. and Japan; in terms of new patents, Germany is second only to the U.S. About one-third of Germany’s medical technology output consists of products that are less than three years old—especially imaging systems, implants, operational and interventional devices and systems, and in-vitro diagnostics.

Innovation is driven by the Medical Technology Action Plan, which pools various federal funding sources to focus on three main categories: medical technology in rehabilitation and care (intelligent implants), molecular imaging, and medical technology for regenerative medicine. (more…)

Pre-IDE Meetings Can Be Helpful in Understanding FDA Expectations

Pre-IDE Meetings Can Be Helpful in Understanding FDA Expectations

Mark Crawford

There are many pressures on medical device companies today—reduced venture capital investment, changing health-care reform, smaller and more complex devices, advanced materials, and the ever-present push from OEMs to keep costs down but get products to market faster, to name a few—all while increasingly managing their supply chains and meeting FDA regulations. (more…)

Mobile Medical Applications Are a Challenge for the FDA

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…)

Q&A with Bill McLain on Internal Audits

Q&A with Bill McLain on Internal Audits

Mark Crawford

Bill McLain is an American Society on Quality (www.asq.org) expert on auditing. He is a member of Regulatory Affairs Professional Society (RAPS) and ASQ’s Biomedical Division. McLain has earned the Regulatory Affairs Certification and holds a Bachelor of Science degree in mechanical engineering from Grove City College.

Q: What is the purpose of doing internal audits? Keeping the FDA from knocking on the door? Keeping clients and end users safe? Saving on operational costs? Being competitive?

There are two main reasons for conducting internal audits. A mature organization will conduct audits because it truly believes in the “plan-do-check-act” cycle. Those organizations realize that internal auditing is one of the best tools available to check what has been implemented. These organizations may be further along in their auditing experience to entrust the auditors with auditing for business improvement, efficiency, and overall effectiveness. (more…)

FDA and CMS Team up to Review Innovative Medical Devices

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…)

Are You Ready for the EU’s New e-Labeling Rules?

Are You Ready for the EU’s New e-Labeling Rules?

Mark Crawford

In June 2011 the European Commission released a draft regulation on e-labeling (http://ec.europa.eu/enterprise/tbt/). The comment period is over and the final version is expected to be adopted on December 14, with activation starting in March 2013. This gives medical device companies about a year to catch up on the details—of which there are many. (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.

Their hope is to reverse the 2007 law that bans experts with financial ties to companies from serving on advisory panels without a waiver. Currently individuals are barred if they have potentially conflicting financial interests exceeding $50,000. (more…)

Beware: Annex 11 Has Implications for Medical Devices

Beware: Annex 11 Has Implications for Medical Devices

Mark Crawford

In January 2011 the European Medicine Evaluation Agency (EMEA) released an updated version of the European Union’s GMP Annex 11 for computerized systems (Annex 11), as well as an expanded version of Chapter 4 on document management.

These are significant changes for the pharmaceutical industry—the new Annex 11, for example, is about four times larger than the older version

EMEA decided to overhaul Annex 11 to keep up with the increased use of computerized systems in all aspects of good manufacturing practice (GMP), as well as their increased complexity. Annex 11 now addresses the regulatory needs of modern IT systems and imparts extensive requirements for compliance at all levels—for example, it dictates how computer printouts of critical records must indicate if any data has been changed since the original entry. Other key topic areas include business continuity, incident management, electronic signatures, migrating and archiving documents, and more comprehensive security controls. (more…)