Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests

A

Adacus

Starting to get Involved
Class 1 product should our class 1 product have regulatory symbols identified on literature
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Humanitarian Device Exemption (HDE) Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classificati Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Postmarketing Safety Reporting for Combination Products Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance – Utilizing Animal Studies to Evaluate Organ Preservation Devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices Medical Device and FDA Regulations and Standards News 0
M Medical Device News FDA News - 03-10-18 - CDRH FY 2019 Proposed Guidance Development and Focused Retrospective Review of Final Guidance Other US Medical Device Regulations 0
shimonv FDA released final guidance documents on what constitutes a significant change Other US Medical Device Regulations 2
M 2016 FDA Final Guidance for Blood Glucose Monitoring Systems - Implementation Other US Medical Device Regulations 2
R Final guidance - FDA Decisions for IDE Clinical Investigations Other US Medical Device Regulations 1
Ajit Basrur FDA issues Final Guidance on Mobile Medical Apps (Applications) US Food and Drug Administration (FDA) 2
S Distribution of IVD products for RUO and IUO-FDA Final Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Final FDA Guidance on IDEs for Early Feasibility Clinical Studies - 2013 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
W FDA's final guidance for Mobile App will final in coming weeks. Medical Information Technology, Medical Software and Health Informatics 0
G FDA Voluntary Audit Report Submission Pilot Program now a final guidance document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S New US FDA Draft Guidance on Final Disclosure by Clinical Investigators US Food and Drug Administration (FDA) 0
M Informational US FDA Final and update guidances – Software Medical Device and FDA Regulations and Standards News 2
M Informational US FDA – Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health – Final Rule Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Report – MDUFA IV Independent Assessment of FDA’s Device Review Process Management Medical Device and FDA Regulations and Standards News 0
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
X FDA UDI (Unique Identification) amendment on 19 Nov 2012 - Date of 'final rule'? US Food and Drug Administration (FDA) 4
Michael Malis FDA final version of Strategic Priorities for the next 5 years US Food and Drug Administration (FDA) 1
S Federal Register - Software Reclassification (MDDS) - Final Decision by FDA yet? Other US Medical Device Regulations 3
Ajit Basrur FDA Issues Final Regulation on Dental Amalgam 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 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 4
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
N FDA mechanical bench testing Manufacturing and Related Processes 5
V Regulatory consultants for US FDA ANDA - pharma / drug products Consultants and Consulting 0
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
S Is it possible to obtain FDA clearance (510k) without meeting QSR? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P Biocompatibility testing ISO-10993 for FDA submission Other Medical Device Related Standards 7
Ed Panek FDA Submission Question US Medical Device Regulations 3
Y The day after the FDA US Food and Drug Administration (FDA) 2
U FDA foreign inspection and COVID19 US Medical Device Regulations 4
Y Convenience pack FDA US Food and Drug Administration (FDA) 3
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
N FDA medical devices US Food and Drug Administration (FDA) 1
R US FDA 510k Australia TGA US Food and Drug Administration (FDA) 0

Similar threads

Top Bottom