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FDA Classifies New Medical Devices Under Special Controls

The FDA has classified several new medical devices into Class II, impacting compliance for manufacturers. This includes devices for sleep apnea testing and Alzheimer's disease assessments.

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FDA Classifies Alzheimer's Disease Pathology Assessment Test

The FDA has classified the Alzheimer's disease pathology assessment test into Class II, requiring compliance with special controls. This classification, published on April 22, 2026, mandates manufacturers to adhere to specific regulatory standards to ensure safety and effectiveness.

Why it matters. Manufacturers of Alzheimer's diagnostic tools must now comply with FDA's Class II standards, affecting market entry timelines and operational costs.

Our readExpect increased scrutiny on Alzheimer's diagnostics as the FDA tightens regulations.

Source · Federal Register

FDA Classifies Sleep Apnea Testing Device Based on Mandibular Movement

The FDA's classification of the sleep apnea testing device into Class II, effective April 22, 2026, introduces special controls that manufacturers must follow. This move underscores the agency's commitment to ensuring the safety of devices used in diagnosing sleep disorders.

Why it matters. Companies developing sleep apnea devices must adapt to new regulatory requirements, impacting product development timelines.

Our readRegulatory compliance for sleep apnea devices is tightening, which may slow innovation in this sector.

Source · Federal Register

Alabama Enacts Comprehensive Privacy Law

Alabama's Governor signed HB 351, the Alabama Personal Data Protection Act, into law on April 17, 2026. This law aligns closely with Connecticut's privacy statute but omits certain requirements like data protection impact assessments, marking Alabama as the second state to pass comprehensive privacy legislation this year.

Why it matters. Businesses operating in Alabama must prepare for compliance with the new privacy law, affecting data handling practices.

Our readAlabama's privacy law could set a precedent for other states considering similar legislation.

Source · InsidePrivacy (Covington)

FTC Alleges OkCupid Data Sharing Violated Consumer Privacy

The FTC announced a settlement with OkCupid and Match Group Americas, alleging violations of Section 5 of the FTC Act for undisclosed data sharing practices. This settlement highlights the agency's ongoing focus on enforcing consumer privacy protections.

Why it matters. Companies must review their data sharing policies to ensure compliance with FTC regulations, especially in light of increasing scrutiny.

Our readExpect heightened enforcement from the FTC regarding data privacy practices across digital platforms.

Source · InsidePrivacy (Covington)

Quick Hits

Also on the desk.

Watch for comments on the FTC's food delivery pricing proposal by May 18, 2026, to gauge regulatory shifts.

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