The Medical Futurist

JUNE 17, 2025

Smart toothbrush While AI helps dental professionals provide better treatments, smart toothbrushes enable all of us to take better care of our teeth. These provide real-time feedback via a companion app warning you if you are applying too much pressure, where you are brushing and even coach the user as to how to brush properly.

Patients 126

Patients Treatment Plan Healthcare Medical Specialty 126

FDA Law Blog

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection.

Telehealth 72

Telehealth Patients Manufacturing Transportation 72

FDA Law Blog

JUNE 22, 2023

To obtain clearance of an OTC home IVD, a sponsor must provide the usual suite of analytical and clinical validation that would be required for any IVD, demonstrating adequate repeatability, stability, sensitivity, specificity, and so on. seeking treatment). This makes seeking clearance of an OTC home test a risky business endeavor.

Manufacturing 59

Manufacturing Clinic IT Transportation 59

FDA Law Blog

DECEMBER 8, 2022

In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq): Jawless fish (e.g., All packaged foods served or sold on transportation carriers (e.g., 1, 2023, sesame. lampreys); Bony fish (e.g., trout); and.

Engineering 59

Engineering Transportation Manufacturing Education 59

FDA Law Blog

NOVEMBER 22, 2022

In an effort to correct some of the bottlenecks in traceability efforts, the final rule imposes additional recordkeeping requirements on domestic and foreign firms who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) for U.S. Some examples of KDEs include: Location descriptions (e.g., Traceability lot code (TLC).

Supply Chain 52

Supply Chain Illness Families Family 52

FDA Law Blog

AUGUST 3, 2021

Although the bipartisan bill largely deals with the nation’s transportation infrastructure, Section 90006 delays the so-called “rebate rule,” a Trump-era rule finalized by the Office of the Inspector General (OIG) of the U.S. See 42 C.F.R. 1001.952(h). See bipartisan bill summary at 5.

Manufacturing 52

Manufacturing Transportation Government Management 52