FDA Issues Draft Guidance on Compliance Policy for Certain NIOSH-Approved Respirators
FDA releases draft guidance proposing reduced regulatory requirements for certain NIOSH-approved respirators. Understand the impact on medical device manufacturers.
New FDA Guidance Clarifies Policy for Low-Risk General Wellness Devices
The FDA has updated its guidance on low-risk general wellness devices, clarifying criteria for software, wearables, and lifestyle technologies that may fall outside device regulation. Effective January 6, 2026.