Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations

You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Clinical Decision Support Software Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational FDA draft guidance – Safer Technologies Program for Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
M Informational US FDA draft guidance. – Clinical Investigations for Prostate Tissue Ablation Devices Medical Device and FDA Regulations and Standards News 2
M Informational US FDA draft guidance – Mouse Embryo Assay for Assisted Reproduction Technology Devices Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Nonbinding Feedback After Certain FDA Inspections of Device Establishments Medical Device and FDA Regulations and Standards News 0
Ronen E FDA releases new draft guidance on when to submit a 510(k) for device modification Other US Medical Device Regulations 10
Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0
Ronen E FDA issues draft guidance on additive manufacturing Other US Medical Device Regulations 1
M New FDA Draft Guidance on 510(k) Ownership and Use Other US Medical Device Regulations 3
R New Draft Guidance Document for FDA's current thinking on De Novo submission Other US Medical Device Regulations 1
S FDA Draft Guidance on HLA Kits 510(k) Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Y New Draft FDA Guidance for Applicability of GLP in Medical Device Submission Other US Medical Device Regulations 2
M FDA issues draft guidance to replace G95-1 (Application of ISO 10993) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Reporting Other US Medical Device Regulations 15
bio_subbu US FDA issues Draft Guidance on Premarket Approval (PMA) Acceptability Other US Medical Device Regulations 0
Ronen E New FDA Draft Guidance on Enteral Connectors Misconnection considerations Other US Medical Device Regulations 0
Ronen E FDA publishes Draft Guidance on Med Dev Pre-Submission Program and Meetings with FDA Other US Medical Device Regulations 0
Ronen E FDA distributes draft guidance related to X-ray Imaging Device 510(k)s Other US Medical Device Regulations 1
Ajit Basrur FDA issues draft guidance on nanotechnology US Food and Drug Administration (FDA) 1
bio_subbu FDA releases draft guidance on Providing Regulatory Submissions in Electronic Format Other US Medical Device Regulations 1
bio_subbu FDA issues draft PMA (Pre-Market Approval) Clinical Study Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
sagai New Draft Guidance from FDA - Factors considered for Risk/Benefit Determination Other US Medical Device Regulations 4
S FDA Draft Guidance on Mobile Medical Applications US Food and Drug Administration (FDA) 1
bio_subbu FDA issues first draft guidance document on Mobile Medical Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
S New draft FDA Classification Guidance US Food and Drug Administration (FDA) 1
S New Draft FDA Guidance - Human Factors & Usability Engineering for Med Device Design US Food and Drug Administration (FDA) 0
S New Draft FDA Guidance on Enforcement of INDs - Safety Reporting Requirements US Food and Drug Administration (FDA) 0
S New US FDA Draft Guidance on Final Disclosure by Clinical Investigators US Food and Drug Administration (FDA) 0
Y Draft FDA Guidance on "Presenting Risk Information in Prescription Drug and Device" US Food and Drug Administration (FDA) 1
Ajit Basrur FDA releases new Draft Guidance - Process Validation - Gen Principles and Practices Qualification and Validation (including 21 CFR Part 11) 27
D Upcoming FDA ISO 13485 audit guidance (draft version) ISO 13485:2016 - Medical Device Quality Management Systems 19
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
M Medical Device News FDA Releases Draft Recommendations on Premarket Submissions for Management of Cybersecurity in Medical Devices Other US Medical Device Regulations 0
M Medical Device News FDA news - 05-09-18 - Draft - Uncertainty in Benefit-Risk Determinations Other US Medical Device Regulations 0
Ed Panek Looking for help... FDA Pre Sub, IVD, Investigational level experience US Medical Device Regulations 0
U How should we build the FDA inspection preparedness team for FDA inspections at factories? General Auditing Discussions 0
D FDA combo product-need to define direct & indirect impact regarding safety,quality & regulatory.Can anyone point me in right direction-SupplierMgmt 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B What is meant by "post production" if the device is yet to receive FDA approval? ISO 14971 - Medical Device Risk Management 5
B FDA Requirements for medical device to be used for training purposes only US Food and Drug Administration (FDA) 9
M Class III IVD PMA Amendment to FDA Medical Device and FDA Regulations and Standards News 1
L Verification of wireless QoS and coexistence during FDA certification of medical devices Medical Device and FDA Regulations and Standards News 1
W Notify FDA of Change of Ownership? US Food and Drug Administration (FDA) 2
G FDA requirements for risk analysis US Food and Drug Administration (FDA) 2
V Anyone have templates for FDA GMP Guidelines for supplement manufacturers? US Food and Drug Administration (FDA) 0

Similar threads

Top Bottom