Oversight and accessOver-the-counter glucose sensors changed who can buy a diagnostic
A device class built for diabetes management is now a pharmacy purchase for people with no diagnosis. The clearance covers the sensor, not the interpretation.
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Rules and gaps
Oversight and access
Access to testing expanded faster than the regulatory frameworks around it. This section follows clearance pathways, enforcement, and the categories operating in unresolved territory.
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4
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Over-the-counter clearance
Covers
Laboratory-developed tests
Covers
Supplement regulation
All oversight and access
Newest first. Every piece lists its sources at the foot.
Oversight and access
Oversight and accessWhat gets reviewed before a supplement reaches the shelf
Less than most buyers assume. Understanding the actual framework explains most of the strange things on supplement labels.
Oversight and accessLaboratory-developed tests: the category most consumer diagnostics live in
A large share of the tests sold direct to consumers were never individually reviewed by a regulator. Understanding why explains a lot about the market.
Oversight and accessWho is responsible for a consumer test result
A clinical laboratory report sits inside a chain of professional responsibility. A wellness report frequently does not, and the terms of service usually say so.