Recent warning letters have shed light on common mistakes companies make when responding to 483 findings. Here are a few best practices for addressing FDA’s concerns and mitigating the risk of further regulatory action. 

By Kristen Grumet


In 2014, FDA conducted 527 medical device compliance inspections in the United States, almost half of which resulted in the issuance of an FDA Form 483. 

The window for ensuring that FDA will consider a response before taking further regulatory action is a mere 15 business days after the close of an inspection. As such, companies are expected to correct all deficiencies within that timeframe—a difficult and highly...

January 28th, 2015

The repeal of the 2.3% medical device tax seems more possible now than in the preceding two years because of a Republican Congress and strong bipartisan support.

To take advantage of the wind beneath its sails, AdvaMed, the industry trade group and lobbyist, announced results of a new survey of its membership on Wednesday about what it describes as the damaging effects of the device tax. The Washington, D.C.-based association found that the tax will resulted in 39,000 fewer jobs over the next five years.

Another survey shows a much less dire view of the impact.

AdvaMed's email survey was sent to its more than 300 members between Nov. 20 and Dec. 12 eliciting a grand total of 55 responses. The responding companies...

January 28th, 2015

In October, there was love in the air in Chicago.

At the annual conference of AdvaMed, the medical devices industry's largest lobby group, you couldn't go two steps in McCormick Place without hearing how great the Food and Drug Administration was. This was in marked contrast to the barbs that has been thrown at the agency over the years from device makers citing charges that the agency was slow in responding, burdensome and inconsistent in its requests for data and profoundly mercurial.

In response to a question from this reporter at the conference about this "love fest" FDA's Jeffrey Shuren remarked that the agency had listened to industry and made changes to become more collaborative, more efficient and less...

January 26th, 2015

For wearables to catch on, designers need to consider how they will affect the people who use them. 

By T. Grant Leffingwell

Jins Meme, wearable, smart glasses

Jins Meme smart glasses were one of many wearables on display at CES.


If the 2015 CES consumer technology show is any indication, wearable computing has entered the mainstream. Wearables aren’t just for wrists anymore. The hottest buzz at CES surrounded gadgets that track us from head to toe, from things like headbands that measure brain waves to slippers that stimulate blood circulation.

Yet for all this consumer demand, the year didn’t start off well for wearables...

January 23rd, 2015

The agency should have gone for a notice of proposed rulemaking instead of a draft guidance when it comes to its oversight of laboratory-developed tests.

By Jim Dickinson

In its pending Framework for Regulatory Oversight for Laboratory Developed Tests (LDTs), FDA is making an audacious and potentially futile power grab.

Futile because however justified by public health concerns, the vehicle the agency has chosen is the legally vulnerable guidance document. Like anything FDA says publicly as an institution, the content of guidance documents is there to be weighed, interpreted, and tested in diverse forums (including courtrooms).

Moreover, the content is currently devoid of regulatory force. Every FDA guidance bears on its first page a boldly boxed statement saying it...

January 23rd, 2015
[Image Credit: user Nerthuz]


January 22nd, 2015
TAVR, Lotus heart valve, Boston Scientific Lotus
Boston Scientific's Lotus TAVR Valve System


Transcatheter aortic valve replacement (TAVR) therapy, while expensive, has come to be accepted as a viable and desirable alternative to invasive open-heart surgery to treat patients with diseased heart valves.

Two names dominate the market - Medtronic and Edwards Lifesciences. Various generations of both companies’ products - Edwards' Sapien and Medtronic's CoreValve - are available in the U.S. and physicians have become trained in the choices available.

That means that companies like Boston Scientific may be too late to the party.

"Boston Scientific will be...

January 21st, 2015

Alex Gorsky sounded a positive note in J&J's 2014 year-end earnings call today. Is it blind optimism or a sign of good things ahead for medtech? 


Johnson & Johnson CEO Alex Gorsky knows how to start the year off on a positive note. Although the company's worldwide medical device sales dipped 4.7% in 2014, he seems to already be looking to the future with rose-colored glasses.

According to a Seeking Alpha transcript of the company's fourth-quarter 2014 earnings call today, Gorsky—who also...

January 20th, 2015

Repealing the 2.3% medical device tax has taken on new urgency.

There are bipartisan bills from both the Senate and the House aimed at killing this tax that many in the industry find unpalatable. The tax has been collected for two years.

January 20th, 2015