CDRH

Medical Device Companies – Get Ready for FDA

Are we dealing with a new FDA? I posed this question last summer. In the past couple years, CQ has had quite a few engagements to help medical device companies during FDA inspections and to correct FDA 483 and warning letter observations. Data also supports my anecdotal experience as reported in a recent post on the AssurX blog:

2005: FDA CDRH inspected 2,304. 2011: 3,369. I’m guessing the number was higher still in 2012
2008: CDRH issued 152 warning letters. 2010: 200 issued.
2008: CDRH issued ~4,000 483 observations. 2010: ~5,000.

Sometimes we have a chance to engage prior to a FDA inspection. In these situations, the process is usually a little smoother and calmer and a whole lot less stressful. These are the medical device companies who have enough clairvoyance to realize their shortcomings and are interested in developing an action plan to correct issues. These are the medical device companies who are doing their best to prepare for a visit by FDA.

And other times we don’t get involved until the FDA inspection is over and 483 observations (and sometimes a warning letter) have been issued. There has been a case or two when a medical device company has reacted with a bit of shock and awe after a FDA inspection. Reactions of real surprise. Sorry – but there really shouldn’t be that much of a surprise after a FDA inspection. Okay, the FDA quality system regulations are not entirely black and white. But the QSR is published–has been for quite some time. And a medical device company should have implemented policies and procedures to address the regulations and be active in keeping company procedures current. However, the companies which are suddenly surprised after the inspection did not do a good job of keeping policies and procedures up to date.

Has it been a while since your medical device company has had a FDA inspection? Don’t think FDA will come visit your company? You might be right. I suggest, though, that you get prepared–just in case.

Life Sciences in the Midwest (510K Reform) – January 2011

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