New FDA import computer system.

The FDA will this fiscal year implement a new computer system for importing of FDA-regulated goods, including medical devices. The system is called PREDICT and relies heavily on the completeness and accuracy of the data provided by the importer. For instance, the foreign manufacturer and the foreign exporter must be known to the FDA through their registration numbers. Of course, so must the importer and the device. Read the FDA's presentation PREDICT.pdf.

Tax incentives in Canada

I recently attended a seminar by Canadian government representatives detailing tax incentives given to companies who are willing to invest in Canada. These incentives are substantial (but too complex to repeat here). A new medical device company is apparently "hooked" as read in The Chronicle Journal.

CDRH's document developments

CDRH has published a list of documents that they will be developing this (fiscal) year. Typically, these documents will be open for public comment before they're finalized, so if you are interested, check it out!

How about some good news?

Angels are investing in more companies this year, with health care/medical devices receiving 28% of total investments, according to the Pittsburgh Business Times. Congrats!

"Device Tax"

I must admit that I have not followed the details of the "medical device tax" in the various proposals for healthcare reform. Medical Device Link posted this article about a new proposal to halve that tax. How is this going to work out? One thing seems to be certain: the industry will have to pay more for what exactly??? Ever since the FDA got the first MDUFMA approved (instituting fees for services we don't want but are mandated by law) the idea of industry sectors to pay for oversight seems to gain more and more traction. As long as the US controls the biggest medical device market in the world, that'll work, but has nobody noticed how much that position is eroding?

Warning letters for lack of MDR procedures

The FDA wrote warning letters to 16 laser eye centers (probably all under the same ownership) throughout the country for the lack of written MDR procedures. The MDR procedures are part of 21CFR803, whereas the Quality System Regulation (QSR) is codified in 21CFR820; that might be a reason that the MDR procedures are often overlooked. In my experience, the FDA is now actively checking for those procedures, but a few years ago they were not that keen. So make sure that you have these MDR procedures!

Neither pretty nor pink: musings on cancer

I want to share this article with you, not because it has anything to do with BesTech (or Regulatory Affairs) but because the author has an interesting take on how our society treats "cancer" in general. I picked it up from Medical Device Daily Perspectives, and couldn't find a link to the article so I just copied and pasted the whole thing.


Neither pretty nor pink: musings on cancer
By ROXANNA GUILFORD-BLAKE
Medical Device Daily Contributing Writer
This is not the column I had planned. But I've had reason to think a lot about cancer lately. The older I get, the more friends I have who are coping with it.
But while the reality of cancer reminds me of how devastating it can be, the marketing of breast cancer suggests it's a mere inconvenience – and a sweetly empowering one at that.
Perhaps because it's Breast Cancer Awareness Month, I'm encountering all sorts of efforts to make breast cancer pretty or noble or sexy. It isn't. Breast cancer has killed one friend and inflicted misery on several others.
Attempts to "perkify" breast cancer with pink ribbons, pink tops on yogurt, pink magnetic ribbons, pink ad nauseam can distract us from this: Cancer is an ugly, insidious disease.
In the interest of full disclosure, many of my breast-cancer survivor friends do wear the ribbons. And they have every right to do so – and if they asked me to, I'd don one. But breast cancer has become a marketing tool. Everyone wants a piece of the action, and breast cancer moves merchandise. (I don't even have time to address the latest trend – sex appeal. Newsweek blogger Kate Dailey asks "Sexy Breast–Cancer Ads: Provocative or Patronizing?" My answer: Yes – and hell, yes.)
I'm not the first curmudgeon to be pinked off at the whole thing. Barbara Ehrenreich tackled this almost a decade ago, after her own battle with breast cancer. Her essay "Welcome to Cancerland" excoriates all things pink and perky. She writes: "In the harshest judgment, the breast-cancer cult serves as an accomplice in global poisoning – normalizing cancer, prettying it up, even presenting it, perversely, as a positive and enviable experience."
Declawing cancer
I can't help thinking Ehrenreich is right. We may be raising awareness – and even money – but we're also declawing cancer. Especially breast cancer.
I don't object to cause marketing. It can raise awareness of all sorts of issues. And I suppose if you're going to buy yogurt, choosing the one with pink top does some tiny bit of good – you're tossing a few pennies toward research. (Just keep in mind that, regardless of what you buy, most companies have a cap on what they will contribute. The Breast Cancer Action's "Think Before You Pink" campaign offers questions to ask before buying pink.)
Of course, making a big, warm-and-fuzzy deal over breast cancer does raise awareness, which promotes increased screening, which decreases the mortality rates, right?
Maybe.
Maybe not.
New – controversial – questions are emerging about screening for breast (and prostate) cancer. In summarizing a JAMA commentary, New York Times' Gina Kolata suggests researchers noted that early detection of cancers thought incurable should lead to a decline in late–stage incidence. That's true, she says, for colon and cervical cancers – but not for cancers of the breast and prostate cancer.
Pink and green
What is true is that raising awareness raises money for research and treatment.
This is the tricky part: I do not begrudge breast cancer one cent of its funding or one second of its coverage. And pitting one disease against another is a nasty, no-win business. But breast cancer does receive a disproportionate amount of attention. Perhaps rather than shining a spotlight on one or two cancers, we need to flood the entire stage with light?
Look at how we treat lung cancer: According to Lung Cancer Alliancedata, it kills more people than all the other major cancers combined. This year, it's expected to kill nearly twice as many women as breast cancer. But it only receives a fraction of the funding. (Some of that is due to the "they brought it on themselves" mentality. But more than 60% of new lung cancer patients are former smokers – or people who never smoked at all. In fact, 20% of women being diagnosed now with lung cancer have never smoked.)
Esophageal and pancreatic cancers also have high mortality rates and limited funding. In May, CBS reported that cancers receiving the most funding are seeing the steepest declines. And – perhaps not coincidentally – some of the fastest growing cancers are those with little publicity or funding.
Breast cancer has a high survival rate. That makes it an attractive investment and provides a strong cadre of advocates. Low survival rates for pancreatic and lung cancer mean there aren't lot of folks left to do the lobbying.
Not a popularity contest
I realize my position is unrealistic: Don't take money from breast cancer; just provide adequate funding for all those other cancers. So be it. I am deeply uncomfortable with the notion that somehow, breast cancer is more palatable – and fundable – because it's prettily packaged.
I do want to "save the ta-tas," as one campaign so elegantly puts it. But I'm far more interested in saving lives, regardless of the cancer type. I want to see technology advance to the point where cancer is merely an inconvenience. Sweet or otherwise.