JD Supra

Can What the Supreme Court Said About Device Clearance in Lohr, a “Derelict on the Waters of the Law,” Finally Be Sunk?[1]

[2] Even though they are still quoted, statements in Medtronic v. Lohr[3], which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no ...
MD&M East

Curiouser and Curiouser… Petitioner on Class III Devices Gets an Answer from FDA

When I was writing last month’s column about former CDRH engineer Leroy Hamilton’s down-the-rabbit-hole quest for a better Form FDA-3429 for guiding device classifications at CDRH, I had no way of ...
JD Supra

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary JANUARY 15 HHS NOTICE RECONSIDERED BY ...
Government Technology

Study Links Digital Device Distractions With Lower Grades

(TNS) — A majority of teenagers in the United States reported becoming distracted when using digital devices in class, and it has some correlation with their academic performance, according to results ...
WIBC

Bill To Restrict Wireless Device Use In Class

STATEHOUSE–A bill that would restrict when students can use cell phones and other devices in the classroom is another step closer to becoming law in Indiana. That bill passed unanimously out of the ...