FINAL ORDER: Premarket Approval for AED Systems:

somashekar

Staff member
Super Moderator
#1
The FDA issued a Final Order: Premarket Approval for Automated External Defibrillator System on January 28, 2015, which represents a tailored approach to help manufacturers assure the quality and reliability of AEDs. AEDs can be highly effective in saving the lives of people suffering cardiac arrest when used in the first few minutes following collapse from cardiac arrest. To help to assure the quality and reliability of AEDs, the FDA is requiring manufacturers to obtain premarket approval for all future and currently-marketed AEDs and necessary AED accessories (e.g., pad electrodes, batteries, adapters and hardware keys for pediatric use).
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
I Mother bobbin final inspection criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
M Informational EU – MDCG 2019-12 Designating authority’s final assessment form: Key Information Medical Device and FDA Regulations and Standards News 0
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 and update guidances – Software Medical Device and FDA Regulations and Standards News 2
M Informational USFDA final guidance – Safety and Performance Based Pathway 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 Final guidance – GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carc Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
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
V Removing final inspector for medical device manufacturing Lean in Manufacturing and Service Industries 4
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 – 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 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 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
T Final process capability results - What I am supposed to present? Cp and CpK? APQP and PPAP 11
M Informational IMDRF final document – Assembly and Technical Guide for IMDRF Table of Contents Submissions Medical Device and FDA Regulations and Standards News 4
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
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
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 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 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
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures 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
M CE / FCC Compliance for components + final product CE Marking (Conformité Européene) / CB Scheme 2
JoCam Medical Device Final Assembly Labelling EU Medical Device Regulations 2
shimonv FDA released final guidance documents on what constitutes a significant change Other US Medical Device Regulations 2
T Primary & Secondary Inspection Definitions - Incoming, In-process & Final Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
C Serialization at Final Quality Check ISO 13485:2016 - Medical Device Quality Management Systems 3
SteveK Final Medical Device Regulations replacing MDD 93/42/EEC, etc. EU Medical Device Regulations 15
S 100% Final Inspection Requirements of Active Medical Devices (MDD or IEC Standards?) EU Medical Device Regulations 4
M 2016 FDA Final Guidance for Blood Glucose Monitoring Systems - Implementation Other US Medical Device Regulations 2
M Final rule on use of symbols on labeling - Symbols without text under some conditions Other US Medical Device Regulations 12
QMMike Software to Record Detailed Final Audit / Inspection Data Software Quality Assurance 2
S Using Calibrated OD mic over non-Calibrated ID mic for final dimension Manufacturing and Related Processes 17
S Required PFMEA Content - Final QC Inspection FMEA and Control Plans 7
bio_subbu USFDA issues final guidance on "Reprocessing Medical Devices in Health Care Settings" Other US Medical Device Regulations 1
M Who has the final say on which subclauses are applicable from a given standard? EU Medical Device Regulations 1

Similar threads

Top Bottom