Regulatory Language Discussion

There is no statu­to­ry def­i­n­i­tion of Med­ical Device. 21 U.S. Code § 321 defines only a device. The phrase med­ical device is used to dis­tin­guish a med­ical from non-med­ical device — but statu­to­ry lan­guage only enables an indi­vid­ual to dis­tin­guish a med­ical from a non-med­ical device using con­fus­ing linguistics.

Normal Person

A nor­mal per­son is one of rea­son­able edu­ca­tion and skill. A nor­mal per­son is not:

• Schooled in law
• Skilled to find detailed legal research
• Skilled enough to under­stand case law
• Skilled enough to under­stand poor­ly writ­ten laws
• Sus­pi­cious that Con­gress inten­tion­al­ly write laws intend­ed to confuse.

The Vague­ness Doc­trine requires laws to be under­stand­able by a nor­mal per­son. It pro­tects all peo­ple from all pros­e­cu­tion for poor­ly writ­ten or unclear laws. The use of trick­ery in writ­ing laws that inten­tion­al­ly or acci­den­tal­ly con­fuse an audi­ence overt­ly vio­lates the vague­ness doc­trine. See Rules for Statu­to­ry Construction

Intent

The statute is vague because uses the word intent. In the def­i­n­i­tion, the word “intent” is unclear­ly asso­ci­at­ed with a par­ty involved in the device usage. Does the intent apply to:

• The user of the device?
• The man­u­fac­tur­er of the device?
• Both man­u­fac­tur­er and the user as intent for user on behalf of the manufacturer?

Since intent broad­ly deter­mines the applic­a­bil­i­ty of FDA reg­u­la­to­ry author­i­ty over devices, the asso­ci­a­tion of the intent to a spe­cif­ic par­ty is crit­i­cal to under­stand­ing the statute. 

Absent this infor­ma­tion it is impos­si­ble for an aver­age cit­i­zen to deter­mine what devices are to be deemed by man­u­fac­tur­ers, users, or reg­u­la­tors, as med­ical devices, as non-med­ical devices, or when. This gross uncer­tain­ty invites the chal­lenge that ALL statutes that rely on the def­i­n­i­tion of med­ical device may be void for vagueness

Who has intent?

In the dumb­bell exam­ple, the statu­to­ry lan­guage con­founds whether the def­i­n­i­tion of med­ical devices depends on the intent of the user, the intent of the man­u­fac­tur­er, or the intent of the man­u­fac­tur­er on behalf of the user.

Statute writ­ers are oblig­ed to write clear­ly. The legal stan­dard for statutes is that they must be under­stand­able by an aver­age cit­i­zen. In the bar­bell exam­ple, one must pre­sume the per­son who man­u­fac­tures a bar­bell is an aver­age cit­i­zen; and that the user is an aver­age citizen.

Inso­far this per­son, an aver­age cit­i­zen, will be con­fused and will be unable to deter­mine whether or his device, and thus he, is reg­u­lat­ed — by read­ing a reg­u­la­tion — then the courts would seem like­ly to deem the reg­u­la­tions that rely on this def­i­n­i­tion void for vagueness.

Vagueness Doctrine

The vague­ness doc­trine com­pels law­mak­ers to be clear. Courts deem unclear laws void. Void means there is no law what­so­ev­er; unen­force­able means a law does not apply a par­tic­u­lar case. Were a court to deem the statu­to­ry def­i­n­i­tion of med­ical device void for vague­ness — no device could be deemed a med­ical device.

From Wikipedia:

In American constitutional law, a statute is void for vagueness and unenforceable if it is too vague for the average citizen to understand or if a term cannot be strictly defined and is not defined anywhere in such law, thus violating the vagueness doctrine. There are several reasons a statute may be considered vague; in general, a statute might be called void for vagueness reasons when an average citizen cannot generally determine what persons are regulated, what conduct is prohibited, or what punishment may be imposed. For example, criminal laws which do not state explicitly and definitely what conduct is punishable are void for vagueness. A statute is also void for vagueness if a legislature's delegation of authority to judges and/or administrators is so extensive that it would lead to arbitrary prosecutions.[1] Related to the "void for vagueness" concept is the "unconstitutional vagueness" concept (see below).

The Quandry for Enforcement Officials

Applic­a­bil­i­ty of law is not a mat­ter of opin­ion. Law enforce­ment offi­cials are oblig­ed to clear­ly and com­plete­ly under­stand the laws they enforce. This means they must clear­ly and con­cise­ly understand:

• Juris­dic­tion: To whom the law applies
• Pro­hi­bi­tion: The actions the law prohibits
• Appli­ca­tion: The spe­cif­ic by a per­son that con­sti­tutes a vio­la­tion of the law.

An unclear law puts an enforce­ment offi­cial in an impos­si­ble posi­tion. The bar­bell exam­ple above com­pels an enforce­ment offi­cial to decode the appar­ent intent of the law­mak­ers who failed to adhere to clear­ly estab­lished lin­guis­tic stan­dards for leg­isla­tive clar­i­ty when writ­ing laws.

The enforce­ment offi­cial is placed in a trap. If a statute is so poor­ly writ­ten that an expert enforce­ment per­son strug­gles to under­stand the mean­ing, then it clear­ly falls short of the clar­i­ty stan­dards estab­lished by the vague­ness doctrine.

When an enforce­ment offi­cer, a pre­sumed expert, has dif­fi­cul­ty under­stand­ing a statute — then he can­not expect to apply it to an aver­age cit­i­zen. Imag­ine the con­fused offi­cer argu­ing to a con­fused jury why they should hold a con­fused aver­age cit­i­zen account­able to com­ply with a law that nobody understands.

The enforce­ment offi­cer is in a crim­i­nal trap. Enforce­ment offi­cials are pro­hib­it­ed from both arbi­trary enforce­ment of statutes as well as enforce­ment of arbi­trary statutes per 18 USC 242. An enforce­ment offi­cial who does not under­stand, or feels a reg­u­la­tion would be unclear to an aver­age cit­i­zen, has a statu­to­ry oblig­a­tion NOT to enforce it. 

No statute com­pels enforce­ment offi­cials to seek to clar­i­fy unclear­ly writ­ten laws by engag­ing lawmakers. 

An offi­cial who is uncer­tain of the mean­ing of a statute has de fac­to evi­dence that the law can­not be under­stood by an aver­age cit­i­zen. An offi­cial who is uncer­tain of a statute or law, who sub­se­quent attempts to enforce that statute com­mits a will­ful crim­i­nal act pro­hib­it­ed by 18 USC 242.

Deprivation of rights under Color of Law

Who­ev­er, under col­or of any law, statute, ordi­nance, reg­u­la­tion, or cus­tom, will­ful­ly sub­jects any per­son in any State, Ter­ri­to­ry, Com­mon­wealth, Pos­ses­sion, or Dis­trict to the depri­va­tion of any rights, priv­i­leges, or immu­ni­ties secured or pro­tect­ed by the Con­sti­tu­tion or laws of the Unit­ed States, or to dif­fer­ent pun­ish­ments, pains, or penal­ties, on account of such per­son being an alien, or by rea­son of his col­or, or race, than are pre­scribed for the pun­ish­ment of cit­i­zens, shall be fined under this title or impris­oned not more than one year, or both; and if bod­i­ly injury results from the acts com­mit­ted in vio­la­tion of this sec­tion or if such acts include the use, attempt­ed use, or threat­ened use of a dan­ger­ous weapon, explo­sives, or fire, shall be fined under this title or impris­oned not more than ten years, or both; and if death results from the acts com­mit­ted in vio­la­tion of this sec­tion or if such acts include kid­nap­ping or an attempt to kid­nap, aggra­vat­ed sex­u­al abuse, or an attempt to com­mit aggra­vat­ed sex­u­al abuse, or an attempt to kill, shall be fined under this title, or impris­oned for any term of years or for life, or both, or may be sen­tenced to death.

This pro­tects the rights of mem­bers of the pub­lic against inap­pro­pri­ate reg­u­la­to­ry inter­fer­ence, weaponized reg­u­la­to­ry agen­cies, and enforce­ment offi­cials from oper­at­ing beyond their authority. 

In short enforce­ment offi­cials are oblig­ed to under­stand the statutes they seek to enforce.

Back to the Barbell Example

It is absurd to deem a bar­bell a med­ical device.

The same log­ic applies to all exer­cise equip­ment because absent exer­cise — the equip­ment does not def­i­n­i­tion of a device because it per­forms no function.

The vague­ness doc­trine inflicts a harsh require­ment on law­mak­ers to use clear lan­guage under­stand­able by an aver­age cit­i­zen. Laws that do not meet this clar­i­ty stan­dard are sim­ply void. 

The bar­bell exam­ple scru­ti­nizes the statu­to­ry def­i­n­i­tion of a device. 

How does using a bar­bell fit or not the lin­guis­ti­cal­ly per­plex­ing remain­der of a device definition?

Why this document?

It is rea­son­able to con­clude that no aver­age cit­i­zen, and few experts, could ever hope to under­stand what an FDA-reg­u­lat­ed device is or is not by read­ing the statu­to­ry definition. 

Absent this clar­i­ty the courts are led to con­sid­er all laws that use unclear lan­guage void for vague­ness and thus have no effect at all.

Reliance on the poor­ly word­ed def­i­n­i­tion of a device used by the FDA invites scruti­ny. Even if a law or statute is valid — it must be very clear to an enforce­ment agent as well as under­stand­able by a nor­mal cit­i­zen to be enforceable.

An enforce­ment offi­cer who believes that a device should be reg­u­lat­ed by the FDA must first be able to artic­u­late the detailed intent, par­ties pos­sess­ing intent, and tech­ni­cal and meta­bol­ic attrib­ut­es that cre­ate the statu­to­ry con­di­tions that would cause a device to require regulation. 

Once the offi­cer ful­ly under­stands these cri­te­ria rel­a­tive to a par­tic­u­lar device he may con­clude that man­u­fac­tur­er has a statu­to­ry oblig­a­tion to reg­is­ter the device with the FDA. When an offi­cer makes this deter­mi­na­tion, he must con­sult the statutes that com­pel a man­u­fac­tur­er to reg­is­ter a device and inform the man­u­fac­tur­er of the statutes.

If the man­u­fac­tur­er is unable to under­stand the statute(s) because they are impos­si­ble for an aver­age cit­i­zen to under­stand it becomes the duty of the enforce­ment agent to peti­tion law­mak­ers to write clear laws. 

It is not the duty of the enforce­ment offi­cials to explain the unclear statutes to con­fused aver­age citizens.

An enforce­ment offi­cial who believes that a statute is unclear to him, or who believes a law would be unclear to an aver­age cit­i­zen, has an oblig­a­tion to pur­sue clar­i­fi­ca­tion of the statu­to­ry lan­guage with the law­mak­ers who wrote the law pri­or to attempt­ing to enforce it with an aver­age citizen.

As the last step, with a clear statute in hand, agent may engage the aver­age cit­i­zen to seek FDA device reg­is­tra­tion for a device. An agent who does not fol­low this process risks Col­or of Law Violation.