November 2011 Posts

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In July 2011 the FDA released its draft guidance on the use of mobile medical applications.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 The comment period ended October 21 (view the guidance at Draft Guidance for Industry and Food and Drug Administration Staff–Mobile Medical Applications).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…)