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.

Preemption: a blessing or a curse?

A Minnesota judge dismissed a lawsuit against Medtronic over defective defribillator leads because the FDA had approved the leads. The argument is, that if the FDA approves a product, it's approved under Federal law, which would preempt State law. See this article in Mass Device for details.

What is your opinion, is this kind of ruling "good" or "bad"? Obviously, the families of the over 100 patients who died as a result of the bad leads won't be overly joyed. On the other hand, medical device companies now find an (unlikely) ally in the FDA: if a product has inherent defects but is approved anyway, the company goes scott-free. I think there is something wrong with this picture, although I admit that sometimes it is difficult for a company to test a product exhaustively enough to prevent all failures. But then, I've been around long enough to know that companies have a tendency to stick their head in the sand with product "issues" that might affect the bottom line.

Follow your SOP's!

Every week some unfortunate company in the US receives a warning letter from the FDA for not having or not following procedures. Today I picked up this report, which is all too common. The lesson: have procedures, follow them!!

Warning: Devicemaker Can't Prove It Reviewed Sterility Results
Connecticut-based devicemaker Gaven Medical has received an FDA warning letter for manufacturing violations related to its Punctur-Guard winged sets for blood collection. The FDA maintains there is no documentation showing the company reviewed sterility results for one lot of the device prior to its distribution, according to the June 26 letter recently posted to its website. The letter stems from an inspection conducted April 27 through May 8.
The GMP Letter

Want to live "forever"?

I found this interesting article on Medical Device Link about research into regenerative therapies that may help people to regenerate body parts that are damaged or worn out. Do you think that'll be applicable to the human brain also?? And if one were able to regenerate one's brain, would that change one's personality?

FDA's "reduction of paperwork"...

I can't help but being skeptical when the FDA announces another initiative to reduce paperwork. This time it's about collection of information from third party QSR inspectors; see http://edocket.access.gpo.gov/2009/E9-25395.htm. The weird part of these "initiatives" is that they are always accompanied by a mountain of paperwork...

Isn't there another way to curb bureaucracy's appetite for red tape? Please, politicians, step up to the plate and help society to be more effective and less wasteful. We're strangling our own industries by adding more and more rules but forgetting to delete old ones and streamlining processes that are based on 50- or 100-year-old business models.

More power cord failure details

The FDA has already published a detailed report on the power cord failure reported yesterday. You can find the report here.

Power cords are sparking unrest

It seemed surreal to me that something as banal as power cords would cause the FDA to issue a warning, but here it is! Some power cords used with medical devices seem to be unsafe, and the FDA has issued a warning on their website. Happy reading!

GMP for Combination Products

QMN Weekly Bulletin wrote:

Proposed Rule for Combo Products Offers Streamlined GMP Option
Makers of components in co-packaged or single-entity combination products would have two options for showing compliance with quality system requirements for devices and cGMPs for drugs or biologics under a new proposed rule.

For co-packaged or single-entity combination products, the rule proposes that companies demonstrate compliance with all cGMP regulations for each part of the product. Alternatively, companies could develop written procedures for a "streamlined system," which could show compliance with the regulations for either devices or drugs plus certain provisions of the rules for the other component.

"What will be critical for industry to do is to document their revised manufacturing procedures to assure they are fulfilling the supplementary requirements and be able to provide objective evidence of compliance," Steven Niedelman, senior consultant with Crowell & Moring, said. Comments are due by Dec. 22.
The GMP Letter

Small business scams in California

Have you received (a) letter(s) about LLC's and S-Corps needing to file various reports with the State? If so, you're not alone. There are scams out there offering to file these reports for you at an outrageous cost. Read Jan Norman's article about this issue at scams.

Design Control

The attached article by Master Control (a manufacturer of medical device quality control software) is a good reference for companies that design medical devices. In particular, if your quality system is weak, you may want to read this. Keep in mind that quality control procedures are not "computer dependent" in the sense that you need a computer software system to comply with the FDA's requirements. In fact, BesTech offers a comprehensive FDA-compliant quality control system that includes design control. This system is paper-based, keeping the cost low. Read Quality By Design and also check out BesTech's download page for additional information on Design Control.

FDA Warning letters

One of my client's distributors recently got a warning letter from the FDA for illegal claims on his websites. If you advertise your medical device for intended uses that are not included in your 510(k) clearance, your device is "adulterated". The FDA has an array of sanctions available that they can impose, from just "clean up your act" to "recall all products". Things get worse, of course, if your device causes unsafe situations or patient injuries. The FDA is very active researching websites and advertising materials for exaggerated claims, but many of these FDA investigations result from competitors or unhappy customers complaining. So be careful!

OCRA's new website

OCRA, the Orange County Regulatory Affairs Discussion Group, has recently revamped its website. This organization is more than a "Discussion Group": there are now 716 members! OCRA organizes many meetings throughout the year, with a joint FDA-OCRA meeting usually scheduled for June. Check out the OCRA website

FY 2010 registration with the FDA

Yes, it's that time again, and you probably know all about it already: between now and the end of the year, all medical device companies must renew their registration. Not only that, but also pay the new and increased fee of $2,004. The FDA has completely overhauled its website, and it looks different but has not improved. Most of the bookmarks you have collected over the years don't work anymore. Compatibility with any other browser but Internet Explorer for Windows is non-existing. Our taxdollars hard at work!

The FDA found it necessary to publish a 12-page guidance of how to register your company - not a moment too soon, seeing how complex that process has become! Check it out at FDA's website.

Enjoy!