FDA and cloud-based medical device

Digital Health Criteria – FDA

Sep 22, 2017 – Software run on a hardware medical device is a SaMD when not part of the intended use of the hardware medical device. … A picture archiving and communications system consists of cloudbased, web-accessible software that analyzes cardiovascular images acquired from magnetic resonance (MR) …

Medical Device Data Systems – FDA

Jun 9, 2017 – The 21st Century Cures Act (12/13/2016) clarified FDA’s regulation of medical software. The new law amended the definition of “device” in the Food, Drug and Cosmetic Act to exclude certain software functions. The FDA is currently developing draft guidance for public comment to help industry and FDA …

Medical Devices / Radiation-Emitting Products | FDA Voice

Our science-based and patient-centered regulatory approach also extends to medical devices, where we’ve focused on a life-cycle approach to product development. This has allowed us to streamline clinical development protocols without compromising on our commitment to rely on rigorous evidence. By carefully …

Medical Devices > General Principles of Software Validation … – FDA

Jun 14, 2017 – This document is based on generally recognized software validation principles and, therefore, can be applied to any software. For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) …

[PDF]Final Guidance on Medical Device Accessories: Describing … – FDA

Feb 2, 2017 – Final Guidance on Medical Device Accessories: Describing Accessories and Classification. Pathway for New Accessory … therefore also for software as a medical device or SaMD, this guidance is applicable to the …… based or cloudbased software uses support a service activity or a workflow, to support a …

Precision Medicine – FDA

Dec 21, 2017 – The Precision Medicine Initiative seeks to identify genetically-based drivers of disease in order to develop new, more effective treatments. … The FDA created precisionFDA, a cloudbasedcommunity research and development portal that engages users across the world to share data and tools to test, pilot, …

First FDA Approval For Clinical Cloud-Based Deep Learning In …

Jan 20, 2017 – The FDA approval of a cloud based machine learning application to be used in a clinical setting to help physicians understand how a heart is functioning signals a major breakthrough. Cutting examination time from up to an hour to just 15 seconds paves the way for more AI algorithms inhealthcare.

Arterys Receives FDA Clearance For The First Zero-Footprint Medical …

Jan 9, 2017 – SAN FRANCISCO, Jan. 9, 2017 /PRNewswire/ — Arterys, a pioneer in cloudbased medicalimaging software, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Arterys Cardio DLTM application. Arterys Cardio DLTM is the first technology to be cleared by the FDA …

The Impact of Cloud Computing on FDA’s Regulation of Medical …

Feb 14, 2013 – Given the complexity with using cloud computing services in FDA regulated medical products, it is critical to carefully consider the regulatory impact of incorporating such services. Sheppard Mullin has expertise in the legal and regulatory issues surrounding cloud based services, including when using …

Leveraging Cloud-based VDI for Medical Devices – ClearDATA

https://www.cleardata.com › knowledge hub › Blog

Medical devices improve and save lives, but security risks around them are increasing, putting patients and providers at risk. Medical devices help improve patient outcomes and can save lives, and dozens of new technologies are approved by the U.S. Food and Drug Administration (FDA) each year. However, the …

FDA and telehealth

Digital Health – FDA

Dec 7, 2017 – The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devicestelehealth and telemedicine, and personalized medicine. Providers and other stakeholders are using digital health in their efforts to: Reduce inefficiencies,; Improve …

Mobile Medical Applications – FDA

Jump to Does the FDA regulate mobile devices and mobile app stores? – FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers.FDA’s …

Press Announcements > FDA approves first telehealth option to …

Nov 17, 2017 – “Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants. Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatly reduce the burden to …

FDA regulates telemedicine on smart phones : CAMLAW …

http://www.camlawblog.com › New Regulation

As one law firm explains in Is Your Smart Phone An FDA-Regulated Medical Device? – FDA Announces Plans To Regulate “Mobile Medical Applications:”. The FDA views handheld computers loaded with these apps to be medical “devices” subject to extensive FDA regulation. The FDA’s draft guidance sets out its current …

FDA clears telehealth option to remotely program cochlear implants …

Nov 27, 2017 – FDA regulations · Telehealth · Mobile technology. print reprint. The Food and Drug Administration has approved the first telehealth option to remotely program electronic hearing devicescalled cochlear implants, rather than having audiologists make programming adjustments to them at specialized centers …

Thirty-six connected health apps and devices the FDA cleared in 2016 …

Dec 30, 2016 – While connected blood glucose monitors and devices incorporating heart rate sensors dominate the list, we also saw more apps and software … Medtronic received FDA clearance for its AVIVO Mobile Patient Management System, which continuously measures, records and periodically transmits data for …

FDA Establishes New Digital Health Unit « Center for Telehealth and e …

ctel.org › Telehealth Buzz

May 12, 2017 – On the new unit’s agenda: topics like wireless medical devicesmobile apps,telemedicine, software as a medical device, and interoperability, among others. The overall focus will be on bringing “regulatory clarity” to the relatively new and continually evolving industry. In particular, theFDA is seeking to …

FDA OKs Telemedicine Platform for Programming Cochlear Implants

Nov 20, 2017 – The announcement continues a string of FDA approvals over the past month of innovative telemedicine and mHealth devices. This one is designed to help the 58,000 adults and 38,000 children who have received cochlear implants since 2012. The implant is designed to electrically stimulate the nerves …

Remote Patient Monitoring Technologies Addressed by FDA

Jul 31, 2015 – Among the many mobile apps and devices that the FDA does consider under the definition of a medical device but does not pose any serious danger to patients … Another remote patient monitoring solution that’s made an impact is Authentidate’s telemedicine service, which has helped monitor the health of …

Why Mobile Health Applications Require FDA Regulation

Aug 5, 2015 – August 05, 2015 – If a medical device like a pacemaker was to be installed through surgery and hadn’t been thoroughly vetted by the proper agency, what patient would ever allow their doctor to go through with the surgery? It’s likely no such patient exists and healthcare advocates expect all medical …

$50k Humira drug costs per year in the USA

Adalimumab (trade names Humira and Exemptia) is a medication used for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, moderate to severe chronic psoriasis, moderate to severe hidradenitis suppurativa, and juvenile idiopathic arthritis. In rheumatoid arthritis, adalimumab has a response rate similar to methotrexate, and in combination nearly doubles the response rate of methotrexate alone.[1]

Adalimumab is a TNF inhibiting anti-inflammatory biologic medication. Adalimumab binds to tumor necrosis factor-alpha (TNFα). TNFα normally binds to TNFα receptors, which leads to the inflammatory response of autoimmune diseases. By binding to TNFα, adalimumab reduces this inflammatory response. Because TNFα is also part of the immune system that protects the body from infection, treatment with adalimumab may increase the risk of infections. Adalimumab was the first fully human monoclonal antibody drug approved by the FDA. It was derived from phage display,[2] and was discovered through a collaboration between BASF Bioresearch Corporation (Worcester, Massachusetts, a unit of BASF) and Cambridge Antibody Technology as D2E7,[3] then further manufactured at BASF Bioresearch Corporation and developed by BASF Knoll (BASF Pharma) and, ultimately, manufactured and marketed by Abbott Laboratories after the acquisition of BASF Pharma by Abbott. On January 1, 2013 Abbott split into two companies, one retaining the Abbott name and the other named AbbVie. Humira is now owned by AbbVie.

Humira costs approximately $3,100 per month, like the TNF-alpha inhibitor etanercept. In 2012, Humira had $4.3 billion of sales in the US,[4] and $9.3 billion worldwide.[5] In 2014, in India the first adalimumab biosimilar at a price of $200 a dose came to market. Humira’s U.S. patent will expire in 2016.[6] In 2016, another Indian drugmaker Torrent Pharmaceuticals launched a generic biosimilar.


My 80 yr old mother who has aches and pains from being over worked as caregiver uses turmeric and ginger, sulfur rich whole foods, veggies, vinegar, fish and massage of coconut oil with fresh ginger for her arthritis.

What is pharmacogenetics?

Overview: What is pharmacogenetics?

Some of us respond differently than others to the same medications that we take, or we may experience different side-effects from drugs. The way we respond can be due to the genes we have inherited. With respect to drugs, our unique genetic make-up and our individual response may mean that a drug that is effective for one person may be less effective for another or that a drug that is safe for one person may be less safe for another person—even at the same dosage.

Most drugs are broken down (metabolized) in the body by various enzymes. In some cases, an active drug is made inactive (or less active) through metabolism. In other cases, an inactive (or less active) drug is made more active through metabolism. The challenge in drug therapy is to make sure that the active form of a drug stays around long enough to do its job. However, some people have variable enzyme action so that they may metabolize the drug too quickly or too slowly or not at all — meaning that the drug may not produce its intended effect or it may remain in a person’s system too long and may lead to side effects.

Individual response to a drug may also be related to variability in the drug target, for example a protein that the drug binds to in order to produce its specific effect. Furthermore, individuals may experience side-effects (known as hypersensitivity reactions) from certain medications due to variability in proteins involved in the immune response.

Pharmacogenetics is the study of genetic variability that causes individual responses to medications. By analyzing the genes that produce the specific drug targets or enzymes that metabolize a medication or are associated with immune response, a doctor may decide to raise or lower the dose or even change to a different drug. The decision about which drug to prescribe may also be influenced by other drugs the person is taking, in order to avoid drug-drug interactions.

The terms “pharmacogenetics” and “pharmacogenomics” are sometimes used interchangeably. There are subtle differences in the meaning of the two terms and there is no consensus on the exact definitions. In general, pharmacogenomics refers to the overall study of the many various genes that contribute to drug response. Pharmacogenetics is the study and evaluation of the inherited differences (genetic variations) that affect drug metabolism and an individual’s response to medications. For the purposes of this article, the term pharmacogenetics will be used.

 Why is pharmacogenetics important?

When initiating drug therapy to treat a particular condition, doctors typically prescribe one of several appropriate drugs. Dosages and timing of drugs are usually based upon the anticipated rate of metabolism and clearance from the body in the average person. They prescribe a “standard” dose based on factors such as weight, sex, and age. Clinically, however, each person responds uniquely to treatment and doctors must make adjustments. For example, the doctor may adjust the drug dose or switch to a different therapy, depending on whether the person’s condition is responding to the medication and whether the individual is experiencing unpleasant or dangerous side effects. Sometimes a person may find that a treatment that has been working well for them suddenly causes symptoms when they start taking an additional drug.

The concentrations or effects of some drugs are monitored with blood tests and the drug dosages may be increased or decreased to maintain the drug level in an established therapeutic range. Follow-up of drug concentration is called “Therapeutic Drug Monitoring.” If changing the drug dose is not effective in treating or controlling the person’s condition, or the person still has side effects, then the person may be given a different drug.

In contrast, pharmacogenetics offers physicians the opportunity to individualize drug therapy for people based on their genetic make-up. Testing people prior to initiating drug therapy to determine their likely response to different classes of drugs is a key emerging area of testing. Such genetic information could prove useful to both the doctor and patient when choosing current and future drug therapies and drug doses. For certain medications, pharmacogenetics is already helping physicians predetermine proper therapies and dosages to have a better chance of achieving the desired therapeutic effect while reducing the likelihood of adverse effects.


How does pharmacogenetic testing work?

Genes are the basic units of genetic material, the segments of DNA that usually code for the production of specific proteins, including the proteins known as enzymes. Each person has two copies of most genes: one copy is inherited from their mother and one copy is inherited from their father. Each gene is made up of a specific genetic code, which is a sequence of nucleotides. Each nucleotide can be one of four different nucleotides (A, T, G, or C). For each nucleotide position in the gene, one of the four nucleotides is the predominant nucleotide in the general population. This nucleotide is usually referred to as “wild type.” If an individual has a nucleotide that is different from “wild type” in one copy of their genes, that person is said to have a heterozygous variant. If an individual has the same variant nucleotide in both copies of their genes, that person is said to have a homozygous variant.

Nucleotide or genetic variants (also called polymorphisms or mutations) occur throughout the population. Some genetic variants are benign — do not produce any known negative effect or may be associated with features like height, hair color, and eye color. Other genetic variants may be known to cause specific diseases. Other variants may be associated with variable response to specific medications.

Pharmacogenetic tests look for genetic variants that are associated with variable response to specific medications. These variants occur in genes that code for drug-metabolizing enzymes, drug targets, or proteins involved in immune response. Pharmacogenetic tests have the ability to determine if a variant is heterozygous or homozygous, which can impact an individual’s response or reaction to a drug.

 When are the tests ordered?

A doctor may test a patient’s genes for certain variations that are known to be involved in variable response to a medication at any time during treatment (for example, prior to treatment, during initial phase of treatment, or later in the treatment). The results of the testing may be combined with the individual’s clinical information, including age, weight, health and other drugs that they are taking, to help tailor therapy. Sometimes, the doctor may use this information to adjust the medication dose or sometimes to choose a different drug. Pharmacogenetic testing is intended to give the doctor additional information but may not replace the need for therapeutic drug monitoring.

Pharmacogenetic testing for a specific gene is only performed once since a person’s genetic makeup does not change over time. Depending on the medication, a single gene may be ordered or multiple genes may be ordered. An example of a medication for which multiple genes are usually evaluated is warfarin, which can be affected by genetic variation in CYP2C9 and VKORC1.

Testing may be ordered prior to starting specific drug therapies or if a person who has started taking a drug is experiencing side effects or having trouble establishing and/or maintaining a stable dose. Sometimes a person may not experience such issues until other medications that affect the metabolism or action of the drug in question are added or discontinued.

The Pharmacogenetic Tests

There are currently a variety of pharmacogenetic tests that can be ordered on a clinical basis. Some tests may only be applicable to specific ethnic groups. The following are some drugs for which pharmacogenetic tests are available:

Drug      Associated Diseases/Conditions  Gene(s) Tested

Warfarin (see Warfarin Sensitivity Testing)

Excessive clotting disorder            VKORC1 and CYP2C9

Thiopurines (azathioprine, mercaptopurine, and thioguanine) (see TPMT)

Autoimmune/Childhood leukemia              TPMT

Clopidogrel (see Clopidogrel (CYP2C19 Genotyping))

Cardiovascular   CYP2C19

Irinotecan           Cancer  UGT1A1

Abacavir              HIV         HLA-B*5701

Carbamazepine, phenytoin           Epilepsy               HLA-B*1502

Some antidepressants, some antiepileptics             Psychiatric, Epilepsy         CYP2D6,CYP2C9, CYP2C19, CYP1A2, SLC6A4,HTR2A/C

Is there anything else I should know?

For most medications, pharmacogenetic tests are generally not widely ordered for a variety of reasons. However, they may be indicated when the medication of interest has a narrow therapeutic range and/or is associated with a high rate of adverse events.

Pharmacogenetic tests are intended to provide the doctor and patient with additional information when selecting drug treatments and dosages. For a better understanding, patients may want to consult with a genetic counselor prior to and after having a pharmacogenetic test performed. Genetic counseling and informed consent are recommended for all genetic testing.

To learn more about the role of pharmacogenetics in personalized medicine, visit the Personalized Medicine Coalition website.

Common Questions

  1. Should everyone have pharmacogenetic tests performed? Currently they are only indicated if a person is going to take, or is taking, a drug that has an accepted pharmacogenetic test associated with it.
  2.  Is pharmacogenetic testing required before taking certain drugs? No. The FDA may recommend this testing, as in the case of irinotecan, but it is not required.
  3.  Why am I only tested once? Your genetic make-up does not change over time. You may, however, have other pharmacogenetic tests performed if you take a different drug with a different associated pharmacogenetic test.
  4.  Does this mean my drug levels do not have to be monitored? No. Since there are other factors that affect drug levels besides your genetics, therapeutic drug monitoring may still be necessary.
  5.  What type of sample is used? A blood sample is obtained by inserting a needle into a vein in the arm. Saliva samples and buccal swabs, collected by brushing the inner side of the cheek with a swab, can also be used.
  6.  How do pharmacogenetic tests differ from genetic tests? Pharmacogenetic tests are performed to evaluate a person’s potential response to a drug therapy. Most genetic tests have been developed to help diagnose or predict the development of a genetic disease, or to detect bacteria and viruses, for forensic medicine purposes, and in establishing parentage.
  7.  Will I be monitored differently after the test? You may be monitored differently depending on the results of the test, especially when starting the medication, changing the dose, or when adding or discontinuing another medication.
  8.  Should other family members be tested? This is a question to discuss with your doctor and your family members. In some cases it may be useful; in others it may only be relevant if they are going to be taking the same drug or a drug in the same class. Pharmacogenetic test results are useful information for a family member to share with the doctor along with the family’s medical history.
  9.  How do I know whether or not I should have testing done? You and your doctor should consider the condition that you have, your history of drug-related side effects and/or adverse drug reactions, the drug therapies that are available, and the uses the test is intended for. Pharmacogenetic tests are not meant to stand alone but are meant to be used in conjunction with your other clinical findings.

Source: http://labtestsonline.org/understanding/analytes/pharmacogenetic-tests/start/4


General Questions

Q: What is genetics? What is genomics?

A: Genetics is the study of inheritance, or the way traits are passed down from one generation to another. Genes carry the instructions for making proteins, which in turn direct the activities of cells and functions of the body that influence traits such as hair and eye color. Genomics is a newer term that describes the study of all the genes in a person, as well as interactions of those genes with each other and with that person’s environment.     Learn more

Q: What does genomics have to do with my health?

A: Genomics plays a part in nine of the Ten Leading Causes of Death in the United States. All human beings are 99.9 percent identical in genetic makeup, but differences in the remaining 0.1 percent may hold important clues about the causes of disease.

We hope that the study of genomics will help us learn why some people get sick from certain infections, environmental factors, and behaviors, while others do not. Better understanding of the interactions between genes and the environment will help us find better ways to improve health and prevent diseases.

 Q: What is the Human Genome Project?

A: The Human Genome Project (HGP) identified all of the genes in human DNA. The project was completed in 2003 by the U.S. Department of Energy and the National Institutes of Health with input from other countries around the world. More information about this project can be found at the HGP Information Web siteExternal Web Site Icon.

 Q: What is stem cell research?

A: Stem cell research is a hot topic in science and the media. Stem cells renew themselves for long periods of time through cell division. When a stem cell divides, it can either remain a stem cell or become another type of cell with a more specialized function such as a blood cell, a muscle cell, or a brain cell. Scientists are investigating using cell- based therapies to treat diseases. To find out more about stem cell research, visit the National Institutes of Health Web siteExternal Web Site Icon.

Q: What is gene therapy?

A: Gene therapy is a technique for correcting faulty genes responsible for disease development. To learn more about gene therapy visit the Human Genome Project Web siteExternal Web Site Icon.

Q: Where can I find out about cloning?

A: The term cloning that you might have heard or read about in the news usually refers only to one type called reproductive cloning. There are actually three types of cloning technologies and they include (1) recombinant DNA technology or DNA cloning, (2) reproductive cloning, and (3) therapeutic cloning. To get more in-depth, reliable information about cloning, visit the Human Genome Project Information Web siteExternal Web Site Icon.

Q: For additional FAQs about Genomics, visit the following Web sites:

A: Genetic Research: Frequently asked questions about genetics research.

Understanding Gene Testing:External Web Site Icon Frequently asked questions about genetic testing.

The Department of Energy (DOE) presents FAQs on the following topics:

  • PharmacogenomicsExternal Web Site Icon
  • Gene TestingExternal Web Site Icon
  • Gene Therapy External Web Site Icon
  • Genetic CounselingExternal Web Site Icon
  • Human Genome Project External Web Site Icon

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Examples of Mobile Apps For Which the FDA Will Exercise Enforcement Discretion

This list provides examples of mobile apps that MAY meet the definition of medical device but for which FDA intends to exercise enforcement discretion. These mobile apps may be intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.  Even though these mobile apps MAY meet the definition of medical device, FDA intends to exercise enforcement discretion for these mobile apps because they pose lower risk to the public.

The FDA understands that there may be other unique and innovative mobile apps that may not be covered in this list that may also constitute healthcare related mobile apps. This list is not exhaustive; it is only intended to provide clarity and assistance in identifying the mobile apps that will not be subject to regulatory requirements at this time.

Appendix B in the guidance includes examples of mobile apps for which the FDA intends to exercise enforcement discretion at the time the guidance was finalized.  As part of FDA’s ongoing effort to provide clarity to mobile app manufacturers this page includes all examples in Appendix B as well as updates with additional examples.

  • Mobile apps that help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing a “Skill of the Day” behavioral technique or audio messages that the user can access when experiencing increased anxiety;
  • Mobile apps that provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women;
  • Mobile apps that use GPS location information to alert asthmatics of environmental conditions that may cause asthma symptoms or alert an addiction patient (substance abusers) when near a pre-identified, high-risk location;
  • Mobile apps that use video and video games to motivate patients to do their physical therapy exercises at home;
  • Mobile apps that prompt a user to enter which herb and drug they would like to take concurrently and provide information about whether interactions have been seen in the literature and a summary of what type of interaction was reported;
  • Mobile apps that help asthmatics track inhaler usage, asthma episodes experienced, location of user at the time of an attack, or environmental triggers of asthma attacks;
  • Mobile apps that prompt the user to manually enter symptomatic, behavioral or environmental information, the specifics of which are pre-defined by a health care provider, and store the information for later review;
  • Mobile apps that use patient characteristics such as age, sex, and behavioral risk factors to provide patient-specific screening, counseling and preventive recommendations from well-known and established authorities;
  • Mobile apps that use a checklist of common signs and symptoms to provide a list of possible medical conditions and advice on when to consult a health care provider;
  • Mobile apps that guide a user through a questionnaire of signs and symptoms to provide a recommendation for the type of health care facility most appropriate to their needs;
  • Mobile apps that record the clinical conversation a clinician has with a patient and sends it (or a link) to the patient to access after the visit;
  • Mobile apps that are intended to allow a user to initiate a pre-specified nurse call or emergency call using broadband or cellular phone technology;
  • Mobile apps that enable a patient or caregiver to create and send an alert or general emergency notification to first responders;
  • Mobile apps that keep track of medications and provide user-configured reminders for improved medication adherence;
  • Mobile apps that provide patients a portal into their own health information, such as access to information captured during a previous clinical visit or historical trending and comparison of vital signs (e.g., body temperature, heart rate, blood pressure, or respiratory rate);
  • Mobile apps that aggregate and display trends in personal health incidents (e.g., hospitalization rates or alert notification rates);
  • Mobile apps that allow a user to collect (electronically or manually entered) blood pressure data and share this data through e-mail, track and trend it, or upload it to a personal or electronic health record;
  • Mobile apps that provide oral health reminders or tracking tools for users with gum disease;
  • Mobile apps that provide prediabetes patients with guidance or tools to help them develop better eating habits or increase physical activity;
  • Mobile apps that display, at opportune times, images or other messages for a substance abuser who wants to stop addictive behavior;
  • Mobile apps1 that are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness, such as those that:
    • Provide tools to promote or encourage healthy eating, exercise, weight loss or other activities generally related to a healthy lifestyle or wellness;
    • Provide dietary logs, calorie counters or make dietary suggestions;
    • Provide meal planners and recipes;
    • Track general daily activities or make exercise or posture suggestions;
    • Track a normal baby’s sleeping and feeding habits;
    • Actively monitor and trend exercise activity;
    • Help healthy people track the quantity or quality of their normal sleep patterns;
    • Provide and track scores from mind-challenging games or generic “brain age” tests;
    • Provide daily motivational tips (e.g., via text or other types of messaging) to reduce stress and promote a positive mental outlook;
    • Use social gaming to encourage healthy lifestyle habits;
    • Calculate calories burned in a workout.
  • Mobile apps for providers that help track or manage patient immunizations by assessing the need for immunization, consent form, and immunization lot number [Added March 12, 2014];
  • Mobile apps that provide drug-drug interactions and relevant safety information (side effects,  drug interactions, active ingredient) as a report based on demographic data (age, gender), clinical information (current diagnosis), and current medications [Added March 12, 2014];
  • Mobile apps that enable, during an encounter, a health care provider to access their patient’s personal health record (health information) that is either hosted on a web-based or other platform [Added March 12, 2014];
  • Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record. [Added June 11, 2014].

1 When these items are not marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or do not otherwise meet the definition of medical device, FDA does not regulate them.  When they are marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or otherwise meet the definition of medical device, FDA intends to exercise enforcement discretion.