Center for Devices and Radiological Health

Does the FDA clearance process need an overhaul?

There’s been a lot of talk lately about how the FDA clearance process is doing, and whether it is working or not, depending on who you talk to.

Emergo Group did a study in which they found that application times jumped 37% from 2006 to 2010. In 2006 510(k) applications cleared by the FDA took about 96 days, but that number soared to 132 days in 2010.

But, why are the reviews at FDA taking longer? As part of the MDUFMA/FDAAA reauthorization in 2007, FDA made a promise for interactive review process in a commitment letter to Congress. The Agency stated that it “will continue to incorporate an interactive review process to provide for, and encourage, informal communication between FDA and sponsors to facilitate timely completion of the review process based on accurate and complete information.” The purpose of the interactive review process is to prevent unnecessary delays in the completion of the review, to avoid surprises to the sponsor at the end of the review, and to minimize the number of review cycles. This process would benefit both FDA and 510(k) sponsors, but are reviewers using this process? According to a presentation made by FDA in March 2011, FDA reviewers utilized the interactive review process less in 2010 than they had in previous years.

Technology is rapidly changing – and diverging further from current technology, thus making SE (Substantially Equivalent)decisions harder to prove and review. As new technology becomes more ever more divergent from the predicate device, it becomes all the more difficult for the FDA reviewer to agree with the sponsor’s proposed SE strategy, resulting in longer review times. Quite often the 510(k) submitters aren’t providing FDA with adequate scientific data (performance data) and/or SE strategies (appropriate predicate devices). The bottom line result of these trends is longer review times.

Sen. Al Franken (D-Minn.) sent a letter to Dr. Jeffrey Shuren, director at the Center for Devices & Radiological Health at the U.S. Food & Drug Administration, that urged the agency to include industry input on any recommendations the Institute of Medicine makes about changes to the 510(k) process.

CDRH director Jeffrey Shuren said seven new guidelines are now in preparation, covering the following subjects:

Device modifications that will trigger a 510(k) (expected in June).
Preparing 510(k) submissions (this will include a flow chart indicating what constitutes a new intended use and when clinical data are needed).
Emerging technologies (with device-specific guidance).
How to conduct clinical studies, including the application of least burdensome principles (due in July).
Conducting first-in-human studies.
Conditional approvals (due in late October).
Factors in making benefit and risk determinations (including a discussion of such issues as disease severity and relation to patients’ tolerance of risk).

I, for one, will be interested to see where the whole process leads us.

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