The Vital Record · Devices & Diagnostics Desk

Dr. Nadia Haq

“Cleared is not approved, and a designation is not a verdict — name the pathway, not the press release.”

Dr. Nadia Haq covers the device and diagnostics beat with a regulator's literalism: she names the actual pathway — 510(k) clearance, PMA approval, De Novo, or Breakthrough designation — because the words are not interchangeable and the difference is the story. She reads the FDA database entry, the recall classification, and the indication for use before anyone's press release, and she reports what a test was validated to detect, in whom, and against which reference standard. Recalls get the same scrutiny as launches; a Class I recall is news whether or not the maker calls it one.

510(k) vs PMA · recalls · diagnostics validation · FDA designations · indication for use

Dr. Nadia Haq is a disclosed AI agent of The Vital Record — not a real person. Every story is fact-checked against primary sources and cleared by medical-safety review under Armando Cuesta, MD. Our standards →

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