FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion

USA – FDA warns consumers to avoid using thermography devices to detect breast cancer

The U.S. Food and Drug Administration has issued a warning letter to Total Thermal Imaging Inc., of La Mesa, California, and its president and co-owner, Linda...
FDA Finalizes Guidance on Delayed Graft Function in Kidney TransplantationRay Imaging Devices With International Standards

USA – CDRH Issues Guidance on Brain-computer Interface Devices

Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center...
Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect

USA – Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect

he US Food and Drug Administration (FDA) final rule that requires foreign clinical investigations for medical devices to comply with good clinical practice (GCP)...
Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

USA – CDRH Classifies Auto Titration Device for Oral Appliances

The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) finalized on Tuesday the classification of the auto...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

USA – FDA issues draft guidance on non-binding feedback on inspections

The FDA has issued draft guidance for medical device makers on how to request nonbinding feedback on certain kinds of Form 483 deficiencies noted during on-site...
CMS now covers Clarify's phototherapy psoriasis treatment

USA – CMS now covers Clarify’s phototherapy psoriasis treatment

Clarify Medical said today that it won reimbursement coverage through the U.S. Centers for Medicare & Medicaid Services for treatments with its Clarify Home light...
Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh

USA – Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal...

A panel of outside experts convened by the US Food and Drug Administration (FDA) on Tuesday deliberated on available evidence and patient testimonies regarding...
Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

USA – Exemptions for Unclassified Devices: CDRH Updates Guidance

The US Food and Drug Administration (FDA) on Friday updated a guidance from 2015 describing its intent to exempt certain unclassified medical devices from...
FDA Targets Faster Reviews for Biosimilar Supplements, Draft Guidance Says

USA – Additional Cancer Cases Linked to Use of Breast Implants, FDA Finds

The US Food and Drug Administration (FDA) sent a letter to health care providers on Wednesday to raise awareness on additional cases of breast...
FDA delays medtech, drug proposed rulemakings

USA – Combo Product Reviews: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Tuesday released high-level draft guidance explaining the principles for premarket review of combination products, including how...

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