SBS - The Best Value in QMS software

FDA News USFDA Final Report – MDUFA IV Independent Assessment of FDA’s Device Review Process Management

Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Informational USFDA final guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Unique Device Identification: Convenience Kits Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Rule – Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Guidance – Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 2
M Informational USFDA Final Guidance – Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – The Least Burdensome Provisions: Concept and Principles Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Breakthrough Devices Program final guidance Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Guidance – Manufacturing Site Change Supplements: Content and Submission Medical Device and FDA Regulations and Standards News 1
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
bio_subbu USFDA issues final guidance on "Reprocessing Medical Devices in Health Care Settings" Other US Medical Device Regulations 1
bio_subbu USFDA issues final guidance on Global Unique Device Identification Database (GUDID) Other US Medical Device Regulations 1
bio_subbu USFDA issues Final Guidance Document on InVitro Diagnostic Device (IVD) Studies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational Several revised or updates USFDA guidance - 9/9/2019 Medical Device and FDA Regulations and Standards News 12
M Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Medical Device and FDA Regulations and Standards News 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab ISO 17025 related Discussions 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab US Food and Drug Administration (FDA) 6
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Considerations for Non- Clinical Assessment of Medical Devices containing Nitinol Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph Medical Device and FDA Regulations and Standards News 0
M Informational The USFDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Review framework for artificial intelligence-based medical devices Medical Device and FDA Regulations and Standards News 1
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Ethylene Oxide Sterilization for Medical Devices website Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Guidance – Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Refuse to Accept Policy for 510(k)s Medical Device and FDA Regulations and Standards News 1
M Informational USFDA draft guidance – Nonbinding Feedback After Certain FDA Inspections of Device Establishments Medical Device and FDA Regulations and Standards News 0
M Informational The USFDA Announces General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on March 25-26, 2019 Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL) – Letter to Health Care Providers Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA draft guidance – Principles of Premarket Pathways for Combination Products; Draft Guidance for Industry; Availability Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Safety and Performance Based Pathway Guidance Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Digital Health Update – New actions and documents Medical Device and FDA Regulations and Standards News 0
M FDA News Safety Alert – USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation Medical Device and FDA Regulations and Standards News 0
M FDA News Statement from USFDA on steps to strengthen the long-term safety oversight of the Essure device Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Reclassification of Electroconvulsive Therapy Devices Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Proposes to End Temporary Extension of GUDID’s Grace Period Medical Device and FDA Regulations and Standards News 3
M FDA News USFDA – Announcement of Safer Technologies Program (STeP) Medical Device and FDA Regulations and Standards News 0
M FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Draft Guidance – Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment Medical Device and FDA Regulations and Standards News 0
P DMF (Drug Master File) type V for Sterilization Processes for USFDA Submission Other US Medical Device Regulations 3
J Testing in China accepted by the USFDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
bio_subbu USFDA issues draft Guidance on the Acceptance of Medical Device Clinical Data Other US Medical Device Regulations 1
M Listing Exempt Medical Devices with the USFDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom