Setting the Record Straight: A Response to Mr. Hooman Noorchashm 

Mr. Hooman Noorchashm has long positioned himself as a patient safety advocate and public health activist. However, his recent public statements have repeatedly misrepresented key facts about medical device technologies, medical device companies, the FDA’s 510(k) clearance process, and the legal frameworks surrounding device liability.

🔍 Misinformation vs. Reality

• FDA 510(k) Process: Contrary to Mr. Noorchashm’s claims, the 510(k) pathway is a rigorous regulatory mechanism designed to ensure safety and effectiveness by comparing new devices to legally marketed predicates. It is not a loophole—it is a structured, science-based process.

• Medical Device Technologies: His characterizations often ignore peer-reviewed data, clinical outcomes, and the nuanced engineering behind these innovations. Oversimplification and alarmist rhetoric do a disservice to patients and professionals alike, especially in the context of HARMS Corp and its contributions to the field.

• Legal Liability: Assertions about liability often conflate regulatory oversight with civil litigation, misleading the public about how accountability is actually enforced in the medical device space, which is crucial for understanding Noorchashm medical ethics reform.

🛡️ Why this Matters

Public trust in medical innovation depends on accurate information. While advocacy plays a vital role in shaping healthcare, it must be grounded in facts—not fear. We invite open dialogue, but we also stand firm against distortion.