510(k) viewed from Italy

From Italy comes to us Dr. Maria Donawa, who discusses The Evolving US 510(k) Review Process in a well-wrought, interesting article. The FDA's struggles are followed not only here in the US, but all over the world! I'm just crossing my fingers that the FDA won't succumb to the "runaway bureaucracy" syndrome that is so infectious in government circles. Alas, I'm not optimistic...

FDA's registration and listing: opaque and impossible

I consider myself an "old hand" at registering medical device companies, but I still manage to get myself in trouble. As you probably know, registration must be done on the FDA's website. Recently I tried to register a US subsidiary of a foreign company, and I could not find a way to enter the foreign company's information! Worse, there used to be (albeit in a difficult-to-find place) an email address where one could contact the FDA and get help, but I could not find that anymore! So much for a "customer friendly" and "transparent" FDA.

FDA venturing into medical device design?

What's happening? The FDA announced that they are starting an "External defibrillator improvement initiative" to get industry to improve defibrillators. This is a very interesting development and makes me wonder if we're headed towards government-prescribed "innovation". In my mind this is a slippery slope, and I'd love to hear your comments!

Changes to the 510(k) process - California Healthcare Institute

The California Healthcare Institute has published a white paper titled "Upcoming changes to the 510(k) Process: New Approval Pathways and the impact on Medical Device Development and innovation", available by clicking on the "white paper" link. Interesting reading!

FDA to rescind 510(k) clearance

The FDA is taking steps to rescind the 510(k) clearance of a knee implant because they made errors in the original clearance process. Now we finally know they really are bureaucrats, even though they present themselves as being "scientific". Apparently procedure takes precedence over science. This device has so far been used in over 300 cases over a period of 10 years without any complaints. Read this article in the WSJ and don't forget to go to the Comments tab.

OCTANe's Medical Device & Investor Forum

The annual MDIF will be held this year on 25-26 October in Newport Beach, CA. For more information about the Forum, go to MDIF. Find out who will attend.

FDA's 510(k) process changes: group in Congress is pushing back

A group of 12 lawmakers from the House of Representatives asked the FDA to delay implementation of five proposed changes to the 510(k) process until the FDA provides more details. They did so in a letter to Dr. Hamburg. See the FDA Law blog for more details.

Small gets smaller and smaller...

When I went to college, integrated circuits were "small" and decreasing in size rapidly. Nowadays nanotechnologies work with structures only a few tens of nanometers in size, and researchers turn these into baffling technologies! The latest is depositing fluorescent dyes inside living cells! Even if it's way out of your everyday interest, read this article about Quantum dots.

Is vacation a "right" or a "bonus"?

For Germans (Europeans in general) it's the first, for Americans the second. Read this interesting article about productivity in Germany and the US. As a Dutchman, I can attest that it's true!

Keeping tabs on FDA's performance

Fortunately, the FDA does that for us, and all we need to do is to access the right webpages to find the information. This is how the FDA describes the program: "FDA-TRACK is a new agency-wide program performance management system that monitors over 100 FDA program offices through key performance measures. These measures are developed by the program offices across the FDA and reported on a monthly basis. Each quarter, monthly performance data is analyzed and senior managers present this data to FDA senior leadership." The FDA Track page can be found at the FDA website. Since I am interested in medical devices, I also look at the CDRH Premarket Dashboard.

FDA gets an F for failure to keep its MDUFMA promises

Devicemakers: FDA's Performance Not Meeting MDUFMA Commitment
Even though devicemakers are picking up a growing portion of the tab, the FDA is not holding up its end of the bargain — to be interactive, predictable and timely — that it made under the Medical Device User Fee and Modernization Act (MDUFMA). "We're seeing more and more examples where that interactive collaboration ... may be falling short," Mark Leahey, president of the Medical Device Manufacturers Association, said at a MDUFMA reauthorization meeting last week. "As it currently stands right now, I think our members would be hard pressed to support the continuation of this program."
Devices & Diagnostics Letter

Obesity - how about eating less?

Yes I admit, I'm neither obese nor overweight. But I don't understand why someone who is overweight can't simply eat less? About a decade ago I decided that I needed to lose ten pounds, so I adjusted my diet, lost the ten pounds, and kept them off.

Now sources in the UK are proposing more weight loss surgeries to contain the cost of caring for obese people - is it just me, or is something upside-down here?

Off-label usage

Off-label usage (of drugs and devices) has long been a hot topic. Companies are forbidden to market off-label uses of their products, and Allergan launched a lawsuit to object to that regulation. Unfortunately, they've dropped that lawsuit, see the excerpt below.

Allergan Drops Suit Challenging FDA’s Off-Label Enforcement
The device industry may have lost its best shot at challenging how the FDA regulates off-label use when Allergan agreed to drop its First Amendment lawsuit seeking the right to tell physicians how to safely use a product off label. The company dropped the suit against the FDA last week as part of a $600 million settlement with the Justice Department over its promotion of Botox for off-label uses. Had Allergan successfully pursued the case, device companies would be able to discuss off-label uses as long as they did so honestly and had safety and efficacy data to support the uses, James Beck, an attorney at Dechert, said.
Devices and Diagnostics Letter

We're from the government, we are here to help you...

CDRH Touts Proposed 510(k) Changes as Good News for Device Industry
CDRH is trying to sell devicemakers on suggested changes to the 510(k) process, saying the changes would increase regulatory predictability. “It is not our intent to turn the world upside down for device manufacturers,” Christy Foreman, acting director of CDRH’s Office of Device Evaluation, said during an agency webinar last week. CDRH officials promoted the upsides of a Class IIb process for 510(k) devices that are more likely to require additional clinical information, touting it as a step toward global harmonization. Having such harmonization could lead to devices being simultaneously cleared domestically and abroad, CDRH Director Jeffrey Shuren said.
Devices & Diagnostics Letter

Heather Rosecrans to retire later this month

Director of 510(k) Office Will Retire This Month
A major player in CDRH’s 510(k) process is stepping down just as the agency begins to revamp the device clearance program. Heather Rosecrans, director of CDRH’s 510(k) Office of Device Evaluation, is retiring Sept. 15, FDA spokesman Dick Thompson said. Her departure could be another example of the ongoing turnover at CDRH, John Romans, CEO of BioMedix Vascular Solutions, said, adding that the turnover has resulted in a loss of institutional memory, contributing to the lack of predictability in the clearance process.
Devices & Diagnostics Letter


Hmm, I don't know. I know Ms Rosecrans and she always was rather bureaucratic and inflexible in her dealings with me. Maybe a change would be for the better?

Do you understand this logic?

Unfortunately I don't subscribe to Devices & Diagnostics Letter, but the excerpt below doesn't make sense! I agree that the current 510(k) process is arbitrary and opaque, but surely that will hurt foreign firms more than US firms, I'd think. What is your opinion?

Lawmakers: Better 510(k) Process Key to Keeping Device Jobs in US
Trying to keep devicemakers, and the jobs they provide, in the U.S., lawmakers are urging the FDA to be more transparent and predictable in its review of 510(k)s. Delays in review times and the agency’s unpredictability in reviewing 510(k)s are hurting U.S. devicemakers trying to compete in the global market, as more countries, including China, require devices to be approved in their home country before granting them marketing authorization. As a result, some devicemakers have moved their headquarters to the EU where they can get more timely marketing approval, Sen. Amy Klobuchar (D-Minn.) said.
Devices & Diagnostics Letter

Cooling therapy for heart attack patients

I came across a very interesting article in The Vancouver Sun about cooling the body of heart attack victims to increase their chance of survival.

Batteries

Li-ion batteries have a much higher energy density than most other types of batteries. In addition, their operating temperature range is larger. But now the requirements for these batteries are even notched up higher; see this article in Electronic Design.

More about tubes misconnections

A week ago I blogged about Luer locks misconnections, and today there was an article in the New York Times about this issue. The author of this article blames the FDA for allowing these situations to continue to exists. International efforts are hindered by politics and probably a lack of focus and/or funding. Oh well...

Al Franken gets involved in the 510(k) process

Al Franken, the senator from MN, is talking with industry and FDA about the proposed changes to the 510(k) process, see The Hill/Healthwatch blog.


The FDA's 510(k) process, used to clear medical devices for sale in the US, is no longer suited to the sheer volume of new ideas and new technologies developed to help the medical community to diagnose and treat diseases. In one word, the process is broken. However, fixing it is extremely difficult: on one hand it should not become so cumbersome that innovative small and startup companies cannot afford to develop new products; on the other hand the process needs to be robust enough to protect the public's health. I am glad that politicians weigh in and hopefully provide viewpoints that may balance the discussions. But I also think that nobody will "get it right" because there is no one right answer that covers all situations adequately.

Luer lock misconnections

Luer locks connect medical tubes such as IV tubes and enteral feeding tubes. Sometimes incompatible tubing sets get inadvertently connected, resulting in patient injury or death.

I thought these problems were solved a long time ago, but the FDA does not seem to think so! The FDA has sent a letter to stakeholders to warn them and to ask industry to make these Luer locks incompatible for systems that should not be interconnected.

Colonoscopy made easy

If you've ever had a colonoscopy, you'll know that these procedures are inconvenient and sometimes painful. So you'll be happy to know that the FDA has cleared a virtual colonoscope based on CT techniques, made by iCAD in NH. This technology uses CT to find polyps 6mm in size or larger.

Topsy-turvy: Irish investment in the US.

An Northern-Irish company invests in the US by opening a plant in West Virginia - see this article in the BBC News. Yes, I know Northern Ireland is not the same as the Republic of Ireland, but still one wonders about the timing!

Venture funding up 52% - is there relief in sight for startup companies?

Venture capital investments in the life sciences industry increased by 52% during the second quarter of 2010 compared with the year-prior quarter, with $2.1 billion going toward 234 deals related to biotech and medical devices, according to the MoneyTree report by the National Venture Capital Association and PricewaterhouseCoopers. See this article.

Higher standards for device approval?

Group Calls for Higher Standards for Device Clearances, Approvals
The FDA is being pressured from within to adopt device approval standards similar to those used for drugs. Claiming that weaknesses in the agency’s device approval and clearance process have allowed potentially ineffective devices on the market, a recently published article co-authored by Peter Lurie, a senior adviser in the FDA’s Office of Compliance, asks Congress to raise the approval standards for devices to more closely match those required for drugs. Lurie wrote the article as deputy director of Public Citizen’s Health Research Group before FDA Commissioner Margaret Hamburg hired him last year.
Devices & Diagnostics Letter

Get ready for a slower and more demanding FDA

The FDA has been under fire lately for failures of their oversight processes, and the result is predictable. They're digging in, making the industry pay by demanding more data, more money, and more time. The LA Times has an interesting article about the latest trends.

About OTC (Over The Counter) labeling

An interesting article about OTC labeling argues that shorter labels increase comprehension and reduce resistance to a product. So, if you need to create an OTC label: short is sweet!

Changes to 510(k) process coming

The new CDRH Director, Jeffrey Shuren, has announced major changes to the 510(k) process by the end of the FDA's fiscal year, September 30th. However, he has given no indications of what those changes might be; apparently there will be a public meeting later this month, and the changes are not definite yet. If you are interested in the current 510(k) process, check out the FDA's "simplified" essay and enjoy!

No-Questions-Asked 510(k) OTC-clearance received for Abdominal Toner

One of BesTech's clients, Global Marketing Partners, received OTC-clearance for their abdominal muscle toner. The FDA had no questions or concerns about the 510(k) submission, which reflects very well on the client! They have been very cooperative, made changes to the product at BesTech's request to improve the chance of clearance, and provided all the documentation promptly. Thank you!

510(k) for the Vital Sleep anti-snoring device

The FDA has recently cleared the Vital Sleep anti-snoring device, manufactured by The Snore Reliever Company from Bronx, NY. BesTech wrote and submitted the application. The process took 109 (calendar) days from submission.

Medical errors tending to our young

Sometimes oral medications are administered using parenteral syringes, but these may be accidentally connected to an IV line, even though there are systems to prevent that. The Institute for Safe Medication Practices, in an article  about this subject, again warns against the practice of using parenteral syringes instead of oral syringes.

MDR's must be filed for adverse events overseas!

The FDA called a device "misbranded" in a warning letter to an Italian company because the company failed to file MDR's for adverse events that occurred in Europe. The device is also marketed in the US. The company took the position that non-US adverse events would be exempt from MDR reporting, and the FDA took exception to that, saying "The MDR regulation applies to foreign manufacturers whose devices are in commercial distribution in the US. An adverse event that occurs overseas is reportable under the MDR regulation if the device is one that has been cleared for marketing in the US".
Just so you know!