How many breaches of Section 21 US Code have there been - let us count the ways

(Largely) first posted back in August 2022 here:

Covid19 remedies - the legal ones - by Peter Halligan (substack.com)

A regulator is required by law to be aware of, and report on, certain factors in order to fulfil a key function – quality control.

In the US, this quality control is captured by laws like these:

21 U.S. Code § 351 - Adulterated drugs and devices | U.S. Code | US Law | LII / Legal Information Institute (cornell.edu)

21 U.S. Code § 360d - Performance standards | U.S. Code | US Law | LII / Legal Information Institute (cornell.edu)

Definition: device from 21 USC § 321(h)(1) | LII / Legal Information Institute (cornell.edu)

Here are the section headings from Code 351

“A drug or device shall be deemed to be adulterated—

(a)Poisonous, insanitary, etc., ingredients; adequate controls in manufacture

(b)Strength, quality, or purity differing from official compendium

(c)Misrepresentation of strength, etc., where drug is unrecognized in compendium

(d)Mixture with or substitution of another substance

(e)Devices not in conformity with performance standards

(f)Certain class III devices

(g)Banned devices

(h)Manufacture, packing, storage, or installation of device not in conformity with applicable requirements or conditions

(i)Failure to comply with requirements under which device was exempted for investigational use

(j)Delayed, denied, or limited inspection; refusal to permit entry or inspection

There is much verbiage below each of these section headers, each of which must be monitored by the regulator. Evidence of such monitoring and quality assurance? Well, the How Bad is my Batch ? website provides a wealth of evidence that this is not the case.

Now the next one that applies to Class 2 devices and some Class 3:

 21 U.S. Code § 360d - Performance standards | U.S. Code | US Law | LII / Legal Information Institute (cornell.edu)

(a)Reasonable assurance of safe and effective performance; periodic evaluation

(b)Establishment of a standard

(c)Recognition of standard

(d)Pilot accreditation scheme for conformity assessment

Again, there is a lot more detail within each of these section headings that compel the Health Secretary to complete a performance assessment and publish reports on the Federal Register. I have not looked for such reports, but the absence of any reference to such reports leads me to believe that there are none of any consequence.

But wait, I hear you ask. What is a “device”. From here:

Definition: device from 21 USC § 321(h)(1) | LII / Legal Information Institute (cornell.edu)

(1) The term “device” (except when used in paragraph (n) of this section and in sections 331(i) , 343(f) , 352(c) , and 362(c) of this title ) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 360j( o ) of this title.”

So, what is a Class 2 Device? From here:

Class II Device Definition | Arena (arenasolutions.com)

Examples include powered wheelchairs, pregnancy test kits, catheters, blood pressure cuffs and blood transfusion kits.

And a Class 3 device? From here:

What are Class 3 Medical Devices? - Grants for Medical

Examples include breast implants, defibrillators, pacemakers, Cochlear implants, high-frequency ventilators, fetal blood sampling monitors, implanted prosthetics.

I am sure you can determine which of test kits, injections, masks, etc are assigned to which Class of device.

This also:

https://www.law.cornell.edu/uscode/text/21/360bbb-3

(i)Appropriate conditions designed to ensure that health care professionals administering the product are informed—

(I)that the Secretary has authorized the emergency use of the product;

(II)of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and

(III)of the alternatives to the product that are available, and of their benefits and risks.

(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—

(I)that the Secretary has authorized the emergency use of the product;

(II)of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

(III)of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

(iii)Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the product.

Onwards!

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