Warning Letter — 3B Medical, Inc. dba Reach Health, Inc.
The FDA issued a Warning Letter to 3B Medical, Inc. (doing business as Reach Health, Inc.) following an evaluation by the Center for Devices and Radiological Health.
This notice affects 3B Medical, Inc., its subsidiary Reach Health, Inc., and their internal departments responsible for regulatory compliance, quality management, and medical device distribution.
A Warning Letter from CDRH indicates that the FDA has identified significant violations of regulatory requirements. While the specific nature of the violations is not detailed in the provided excerpt, such letters typically involve issues related to Quality System Regulations (QSR), marketing unauthorized devices, or failure to follow post-market reporting requirements. This represents a heightened level of enforcement that necessitates formal remediation to avoid further legal action or seizure of products.
Regulatory and Quality teams should review all device marketing and manufacturing status to ensure that current distribution aligns with active FDA clearances and registrations. Conduct an internal audit of existing product portfolios to verify that no devices are being marketed without the necessary pre-market authorizations.
FDA Warning Letter issued to: 3B Medical, Inc. dba Reach Health, Inc.. 05/20/2026 — Center for Devices and Radiological Health. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/3b-medical-inc-dba-reach-health-inc-725108-05202026
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