January 2012 Posts

Do You Know Where Your Documents Are?

Mark Crawford

According to the FDA, six words not to utter on FDA inspection day are: “Now, where is that darn document?” (It’s nice the FDA has a sense of humor, at least on paper).

Kidding aside, this is a big-enough issue that the FDA recently offered a seminar to alleviate problems such as:

  • Unscanned paper documents
  • Confusing naming conventions
  • E-mails as documentation
  • Non-functional or non-existent SOPs
  • Missing documents

(more…)

Chinese Market Gets Hotter for Medical Devices

Mark Crawford

Citigroup Global Markets recently surveyed nearly 400 Chinese hospitals (about two percent of the country’s total) from 29 provinces and cities about attitudes toward the medical equipment market, medical consumable market, hospital construction cycle, and county-level hospital market.

Among the key findings:

“We estimate the total market size of the 11 medical equipment segments we surveyed to be about U.S. $5 billion in 2012, and expect the Chinese medical device market to grow about 17% in 2012 on 12% annual growth in medical equipment and 25% annual growth in medical consumables, largely driven by: 1) purchasing budget growth in Class-3 hospitals; 2) county-level hospital upgrade and expansion driven by government investments; and 3) a solid hospital construction cycle in 2012-15,” wrote Citigroup. (more…)

How to Reduce Premarket Review Times

By: Mark Crawford

Medical device manufacturers (MDMs) know all too well how the FDA 510(k) review process of premarket applications for devices can seem to take forever. Although it’s easy to blame the FDA, there is a lot MDMs can do to expedite the process.

According to a new FDA guidance, total review time—the time it takes FDA to review an application and for companies to respond to the FDA’s questions—has increased, primarily due to companies taking more time to respond to requests for additional information. In addition, the number of Additional Information (AI) letters per submission the FDA sends out (“cycles”) has also increased. (more…)

FDA Proposes Guidelines for Improving Representation of Women in Clinical Studies

Mark Crawford

On December 19 the FDA released a new draft guidance recommending improvements to medical device manufacturers’ clinical study designs that do a better job of evaluating the effectiveness of their products for women. The draft guidance can be read at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm283453.htm.

Entitled “Draft Guidance for Industry and Food and Drug Administration Staff Evaluation of Sex Differences in Medical Device Clinical Studies,” the document aims to correct the historic underrepresentation of women in clinical studies. A 2001 report by the U.S. Government Accountability Office (GAO) on FDA-reviewed drug studies found that while women represented 52 percent of study enrollees, 30 percent of study documents did not report outcomes by sex and nearly 40 percent did not report enrollment demographics. A 2009 study of cardiovascular device pre-market applications showed that pivotal studies that reported sex enrolled an average of 33.9 percent women. (more…)