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23andMe Testing Shut Down by FDA

I’ll admit that I’m not an expert on FDA clearance, but I found this notice from the FDA to 23andMe really interesting. As stated in the notice, “23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”

The letter does specify that 23andMe has been working with the FDA since July 2, 2012, but something has gone wrong in 23andMe’s clearance process. It does offer the following explanation of the issues the FDA has:

This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.

Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.

The 23andMe website doesn’t say anything about the FDA letter, but the company did put a statement for the media on their Facebook page. I guess Facebook is the new media hub for organizations (although, I found it from this tweet)

We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

That’s a pretty vague statement. It is interesting that they chose to acknowledge that they haven’t met the FDA’s expectations. You can be sure there’s a whole lot more to this story and 23andMe’s interactions with the FDA.

Considering the big name people behind 23andMe, it will be really interesting to see this battle play out. It could certainly set precedent for many other healthcare applications in the future.

November 25, 2013 I Written By

John Lynn is the Founder of the blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of and John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Possible Office of Mobile Health Proposed to Regulate mHealth

We’ve talked about the FDA regulating mobile apps several times here on Smart Phone Health Care.

And now, a new debate on this topic has surfaced — Who should regulate mHealth apps?

Currently, the question is should the FDA’s Center for Devices and Radiological Health be in charge of regulation, or should an entirely new department be created? Some believe that special attention needs to be given to mHealth, including Rep. Mike Honda. He is introducing a bill called “Healthcare Innovation and Marketplace Technologies Act,” which proposes creating the “Office of Mobile Health.” Several sources state that this bill will “ensure that competition, innovation, and entrepreunership in the mobile app market” won’t be subject to the “regulatory issues” that are usually applied to “traditional, non-software device types.”

As is expected, there are mixed feelings on this, but according to The FDA Law Blog, this “proposed bill is likely to be welcome by many mobile app developers – in particular the same or startup ones who still wonder why their products would be subject to FDA regulatory oversight at all.”

The article finishes with this:

So the question still remains as to whether medical mobile apps should be regulated by FDA’s CDRH, another office independent CDRH, or simply an office separate from FDA altogether.”

They option they failed to mention though, is the possibility of no regulation at all. Regulating mHealth apps could very well stifle creation. If there are a whole bunch of rules and regulations put in place, many would-be app creators may not want to go to the effort of getting approved, and some ideas may never go further. It’s definitely something to think about. Personally, if the only options are to be regulated by the CDRH, or have an mHealth office created, the mHealth office would be more preferable. Then there would be more focus on getting apps and devices regulated quickly and efficiently, and hopefully more willingness to work with app creators. And, if it is true that competition and innovation won’t be affected negatively, it might not the worst thing ever. We’ll see.

October 25, 2012 I Written By

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.

Regulating mHealth Apps: Does it Limit Creativity?

Last year, the FDA announced plans to regulate some smart phone apps that involve medicine or health. The specific apps that would be regulated “are used as an accessory to medical device already regulated by the FDA [or] transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.” In addition, apps that suggest potential diagnoses or treatments for the person using it.

As I was perusing comment boards for various articles about this, the feelings were mixed. Some think that the FDA already has too much control. Others think it totally makes sense. A comment from someone on a Washington Post article sums up how I feel:

Yes, some software that turns a smartphone into medical use has to follow the same rules as developing a medical device — from the first moment you think about it. It’s not hard, but you had better know what you are doing because what the FDA gives you is basically the right to market the device and if you don’t follow the rules, you could end up with is a really neat program that you can’t even talk about to your customers.

I think it definitely makes sense to regulate these things. I mean, there are quack doctors out there that we don’t know about, who seem legitimate; how are we supposed to discern between a quack health app, and one that can actually be trusted? There needs to be some kind of regulation, but the question is — how much?

The issues I find with certain apps, is that if they get too advanced (such as an x-ray), people might start avoiding the doctor because they diagnose themselves. Basically, I think that without regulation, certain apps may seem awesome, but in reality, they have fatal flaws that could be just that — fatal. There shouldn’t be a chance that bad apps could possibly act as an authoritative source.

In the Washington Post article I previously referenced, Bakul Patel, a FDA adviser was interviewed. I thought he made a good point when he said:

We wanted to make sure that we are consistent in regulating medical devices so nothing has changed. If somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.

I mean, that totally makes sense. Just because something is digital doesn’t mean it should be able to bypass requirements. A stethoscope is a stethoscope. End of story.

Overall, I agree with the regulation. If medical and health apps are going to actually be taken seriously, we should be able to see right of the bat if it can actually be trusted as a medical device. I’m not a huge fan of the government controlling everything, so there should definitely be regulation on the apps that could actually determine the health status of a person. However, the rules shouldn’t be so strict that people can’t be creative in what they create. That’s my two cents on the issue, what are your thoughts?

May 23, 2012 I Written By

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.