In the 3rd edition of this series, I’ll spend a little more time examining the regulatory picture. More specifically, I’ll review FDA 510(k) process, which is the regulatory path for market clearance for most medical devices in the U.S. and obviously affects more than just the Midwest. I’ve been planning to write this post for a few weeks. Timing makes sense. FDA recently announced changes to the 510(k) process. And there have been MANY articles and blog posts on the topic. I’ll do my best to summarize.

In a letter from the director of FDA CDRH:

To facilitate innovation in medical devices, the FDA will:

• Streamline the review process for innovative, lower-risk products, called the “de novo” process;
• Publish guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency;
• Develop a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies; and
• Establish a new Center Science Council of senior FDA experts within the agency’s medical device center to assure more timely and consistent science-based decision making.

To bolster the safety of medical devices, the FDA will:

• Establish a public database of important device information, such as medical device labeling and summaries of the basis for the FDA’s decision to clear specific devices; and
• Require a brief description of scientific information regarding the safety and effectiveness known to the manufacturer for select higher-risk devices on a case-by-case basis through device-specific guidance.

The FDA outlines 25 specific actions and timelines for completion in 2011 to make the 510(k) process a blueprint for “smarter medical device oversight”: FDA 510(k) Implementation Timeline.

FDA’s timeline is very aggressive. Good news (or bad): Impact to industry will be understood soon. As I mentioned, there is plenty of information, opinions, articles, etc. on this topic. While most of the articles state the same information, I’m providing some links for you to review:

Medtech Industry Reacts to 510(k) Modifications

FDA to Improve Most Common Review Path for Medical Devices

FDA Releases Plan Intended to Improve the 510(k) Program

FDA Decides on Changes to its 510(k) Program

FDA Rolls Out Aggressive 510(k) Revision Plan

FDA Announces 510(k) Changes

CDRH Chief Shuren: 510(k) Changes Help Close the Innovation Gap

FDA Punts Tough 510(k) Moves