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)...
CDRH Qualifies 3rd Medical Device Development Tool

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...
FDA suggests letting more patients with viral infections into cancer clinical trials

USA – FDA issues draft guidance on non-binding feedback on inspections

The FDA has issued draft guidance for medical device makers on how to request nonbinding feedback on certain kinds of Form 483 deficiencies noted during on-site...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...
CDRH Qualifies 3rd Medical Device Development Tool

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...
TGA Proposes 5 Medical Device Classifications in Line With EU MDR

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...
Combo Product Reviews: FDA Drafts Guidance

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The US Food and Drug Administration (FDA) on Tuesday released high-level draft guidance explaining the principles for premarket review of combination products, including how...
CDRH Qualifies 3rd Medical Device Development Tool

USA – CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions

The US Food and Drug Administration (FDA) on Monday published final guidance on the FD&C Act’s least burdensome provisions for the regulation of medical devices, highlighting...
US FDA Pushes 510(k) Performance Criteria, Predicate Device Policy Changes

USA – US FDA Pushes 510(k) Performance Criteria, Predicate Device Policy Changes

US FDA finalizes Safety and Performance 510(k) registration route; Performance criteria to play greater role in substantial equivalence for qualifying devices; 510(k) predicate...

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