Can the need for FDA authorization of a tool to find infectious people be bypassed by labeling? Background. OTC (over-the-counter, i.e. not requiring a prescription) rapid antigen covid-19 tests are the tests which detect pieces of viral proteins using lateral flow paper strips. Infected individuals with high viral load (i.e. individuals likely to spread the disease to others) are likely to get a positive result, while individuals without covid-19 are likely to get the negative one. The main roadblock for most companies trying to offer rapid antigen OTC at-home tests in the US is the struggle with getting FDA approval, caused by the &quot;diagnostic&quot; perspective of FDA. FDA has &quot;OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality&quot; called IVD office for short below but no office which looks at the tests from public health perspective, i.e. at the tests which can be used to prevent the spread to others. Given the existence of that roadblock, it is interesting to see that in this video at 1:59 a box of rapid antigen &quot;tool&quot; is shown labeled as &quot;NOT-A-TEST&quot;. That motivates the following question. The question. Assume a company wants to sell or give for free rapid antigen &quot;tools&quot; to regular US citizens in the US. These &quot;tools&quot; are intended to detect individuals more likely to spread covid-19 to others. The company does not have (such as approval or EUA) from FDA IVD office to do so. Can it still legally sell or give these &quot;tools&quot; (possibly by the virtue of modifying the labeling of such product)? My research. I am not a lawyer, TINLA. Below I cite 21 USC section numbers, the correspondence between them and FD&amp;C section numbers can be found here. It appears that the requirement to obtain the approval or EUA follows from the following: Such &quot;tool&quot; a device under 21 USC §321 (h) since it is intended for use in diagnosis, mitigation, or prevention of covid-19 in humans. Such &quot;tool&quot; is a class III device under 21 USC §360c (a),(f), since FDA/HHS did not issue any notices to the contrary and covid-19 tests did not exist before May 28, 1976. Such &quot;tool&quot; is in vitro diagnostic device, as defined in 21 CFR 809.3 (see also FDA's IVD FAQ and Congressional Research Service FAQ on covid-19 tests). Thus, my guess is that a company intending to prove they do not need an approval / EUA from FDA's IVD office may want to do one of the following. Argue that the &quot;tool&quot; is intended to warn individuals to be more cautious regarding the spread of the disease to others, and not to improve their own health outcomes. Hence the &quot;tool&quot; is not intended for use in diagnosis, mitigation, or prevention of covid-19, and thus does not fall under the definition of 'device' in 21 USC §321 (h) and FDA's authority. Convince FDA to issue the De Novo classification of the &quot;tool&quot; as class I or class II device excepted from the requirements previously applied to covid-19 tests. Argue that, while the &quot;tool&quot; is a class III device, it is not an IVD device since it is intended to reduce the spread of covid-19 to others, not for the diagnosis or treatment of the person using the &quot;tool&quot;. Thus, it should be excepted from the requirements previously applied to covid-19 tests. I am not sure whether one of the above is a valid legal way to bypass the requirement, or whether there is some other way I am missing.
This is a duck You can label it a chicken if you like but you won’t fool anyone who knows about ducks. The FDA knows about diagnostic devices; calling it something else isn’t going to fool them.
ICE has a degree of authority to deport without court hearing, via an expedited process. The legal framework for such deportations are explained here, and rely on 8 USC 1225. The Secretary of DHS has authority to establish rules, and has recently done so here. The current regulations pertaining to expedited removal are at 8 CFR 253.3. There is no exemption for people being medically treated, for covid-19 or any other reason, but "parole" is available (at the discretion of the attorney general) to "parole" an immigrant if it is "is required to meet a medical emergency". Thus an illegal immigrant in the ICU might be exempt from immediate deportation, but that is at the discretion of the AG. State and local officials do not have the authority to interfere in the enforcement of federal law, even if the state or municipality has declared itself a "sanctuary". The criminal penalties for interference are spelled out here; no law compells cooperation, the law simply prohibits forcible interference.
You can request in advance that you get only a half-dose: there is certainly no law prohibiting making a request. They may refuse or they may agree. If they refuse, you can go elsewhere, but you cannot compel them to do what you ask for, given current law. You can also yell anything you want, or flail about however you want, at your peril. You could seriously hurt yourself by jumping around, and you would not be able to sue them for your stupid actions. Nor could you sue them for assault, since to get the ball rolling, you have to consent to getting the shot. Although consent can be withdrawn, there is the practical matter that you almost certainly cannot effectively communicate withdrawal of consent in the time needed to finish administering the job. If it took 5 minutes to administer the shot, you might be able to say &quot;I changed my mind&quot;, and they would be required to end the treatment, against medical advice.
The use may constitute trademark infringement if it implies sponsorship or endorsement I'm going to assume US jurisdiction for this question, because you've not provided one, and you haven't provided enough car manufacturer names to suggest that this wouldn't apply to the US. I'll also only cover Federal law (the cases were tried in state courts), so be aware that there may be additional responsibilities under state law that I don't examine here. 15 U.S. Code § 1114: (1) Any person who shall, without the consent of the registrant— (a) use in commerce any reproduction, counterfeit, copy, or colorable imitation of a registered mark in connection with the sale, offering for sale, distribution, or advertising of any goods or services on or in connection with which such use is likely to cause confusion, or to cause mistake, or to deceive; or (b) reproduce, counterfeit, copy, or colorably imitate a registered mark and apply such reproduction, counterfeit, copy, or colorable imitation to labels, signs, prints, packages, wrappers, receptacles or advertisements intended to be used in commerce upon or in connection with the sale, offering for sale, distribution, or advertising of goods or services on or in connection with which such use is likely to cause confusion, or to cause mistake, or to deceive, shall be liable in a civil action by the registrant for the remedies hereinafter provided. Under subsection (b) hereof, the registrant shall not be entitled to recover profits or damages unless the acts have been committed with knowledge that such imitation is intended to be used to cause confusion, or to cause mistake, or to deceive. 15 U.S. Code § 1125: (1) Any person who, on or in connection with any goods or services, or any container for goods, uses in commerce any word, term, name, symbol, or device, or any combination thereof, or any false designation of origin, false or misleading description of fact, or false or misleading representation of fact, which— (A) is likely to cause confusion, or to cause mistake, or to deceive as to the affiliation, connection, or association of such person with another person, or as to the origin, sponsorship, or approval of his or her goods, services, or commercial activities by another person, or (B) in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person’s goods, services, or commercial activities, shall be liable in a civil action by any person who believes that he or she is or is likely to be damaged by such act. These actions - the use of the trademarked manufacturer logo within the app - is likely to constitute trademark infringement, if the trademark owner's permission is not sought prior to publication, and the use of the trademark is likely to cause confusion as to the source, sponsorship or approval of the goods. What this means, is that if the trademarks are used in such a way that a reasonable person is likely to think that: The product is an official product from the owner/brand associated with the trademark; The product is sponsored by the owner/brand associated with the trademark; or The product is approved or endorsed by the owner/brand associated with the trademark. Then an action in trademark infringement may be brought by the trademark owner. Consider the following two cases: Polaroid Corp. v. Polarad Elect. Corp., 287 F.2d 492 (2d Cir. 1961) In this case, judgement was made for the defendant, as the defendant's field was not considered close enough to the plaintiff's for there to be a likely chance of confusion. AMF, Inc. v. Sleekcraft Boats, 599 F.2d 341 (9th Cir. 1979) In this case the trial judge decided that the trademarks Slickcraft and Sleekcraft were unlikely to cause confusion. This ruling was overturned on appeal and an injunction was ordered by the court. Possible defenses Nominative use of a mark When a mark is used solely to identify a product, this use is privileged. A descriptive mark used for its primary purpose Descriptive marks are a subtype of trademarks, which are descriptive in nature but have acquired a secondary meaning. Here, using a descriptive mark for its primary purpose has been found not to constitute infringement. General First Amendment protection Satire and parody are generally recognized as defenses if the primary purpose of the use is not directly commercial. If the products are not similar enough to be likely to cause confusion; and The use does not imply endorsement, sponsorship or approval of the product by the trademark owner then it should be fine. It seems that the situation in the question above would not give rise to confusion (unless the car manufacturer also develops an app, for instance), the second issue - endorsement - should be avoided. Many programs will have a legal section that includes ownership information and disclaims any association with the trademark owner(s). I have not been able to locate any cases where the effect of these sections have been tested. Further reading Overview of Trademark Law
There's nothing to cancel. Your employer has made an exception for you, because of the ADA: you are not required to be vaccinated. That doesn't mean you can't be vaccinated. Once your doctor advises you that it's safe to be vaccinated, and once you are vaccinated, you no longer need the exception, but there's no need to cancel it. As far as the weekly tests, they are required as an alternative measure because you aren't vaccinated. Once you are vaccinated, there should be no more need for weekly testing. You may of course inform your employer that your doctor's advice changed that you were vaccinated, and that you therefore no longer require the accommodation that they offered. That should allow you to stop the weekly testing regime, but otherwise it should be the end of it, since at that point everyone should be satisfied.
The COVID restrictions are new enough that there are few court decisions on how to interpret them. There are frequent requests for court injunctions seeking temporary relief. Some pass, some are denied. The website might accuse locations listed there of breaking the restrictions. Making such an accusation in public sounds like a very bad idea, especially if there is no solid documentation. But the aggrieved party would be any location falsely listed. The site may or may not be hosted in Germany. If it is not, it becomes a really interesting question which law applies. You might inform the authorities, but beyond that, forget it.
Read the TOS (Terms of Service) for each DNA service you are considering. Each service will clearly outline the privacy of submitted samples, security of the process of analysis of samples, the storage and distribution (and possible destruction) of the resulting data, and linking of personal names (or the granting of anonymity, if available) to the data. The TOS will give you enough information to determine if you are comfortable with the privacy of the service. The TOS is a legal document; both you and the service are bound by that contract once you submit a sample and pay the fee. The TOS may outline any legal recourse you have against the company for violating the TOS. Each service is bound by the laws of the country where it is located and the countries where it might outsource the analysis, as well as relevant EU law - since you're looking at EU based-services - to provide security and privacy. Those laws will be outlined in the TOS. As an example, read https://dna.ancestry.com/en/legal/us/privacyStatement at ancestry.com about their DNA testing. It's an extensive TOS, and outlines US and EU law, including the Swiss Safe Harbor Framework https://en.wikipedia.org/wiki/International_Safe_Harbor_Privacy_Principles The DNA service, of course, can't guarantee the security of the data - or your personal information - in perpetuity. Companies are sold, TOS documents change (which would have to be subsequently approved by you), data storage systems "leak" information (by insiders and hackers), and on and on. ...but I don't mind doing a lot of research on my own to classify it if I get raw results. And, any kind of site that allows you to compare your DNA profile with others - if it is a different site/service than one that does the DNA analysis - will have its own TOS regarding the privacy of your data and the resulting metadata from comparisons to other DNA profiles.
Summary from comments. (Hat tip @jqning) Daniel Nathan Ballard writes here: [It] is not only improper it is UNLAWFUL and may result in serious repercussions... Such a misuse may constitute false advertising... (“It is no doubt true” that affixing the ‘Trade Mark Registered U.S. Patent Office” notice on goods that are not protected by a federally registered trademark creates “a prima facie case of fraud against the public… .”). ... Such use is also a form of “unclean hands” that can bar the user’s registration of the mark. ... Such a use may also bar the maintenance of an infringement case. ... And the fraudulent use of the trademark registration symbol DOES provide other marketplace participants with standing to oppose the user’s registration of the mark. http://www.avvo.com/legal-answers/use-of---symbol-but-not-federally-registered-1125746.html