Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
Posts published in “USA”
US – Updated Guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug…
FDA issues a Final Rule to Require Medical Device Submissions in Electronic Format
FDA Qualifies MRI Compatibility and Safety Software as a New Medical Device Development Tool
Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway
Statement on new steps to advance innovation in medical device sterilization with ethylene oxide
FDA approves first contact lens indicated to slow the progression of nearsightedness in children
FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection
Devices used for the condition of temporomandibular disorders (TMD), including temporomandibular joint (TMJ) implants.
Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices