US FDA Guidance on Medical Device Establishment Registration and Listing

bio_subbu

Super Moderator
#1
Dear All

The US Food and Drug Administration (FDA) has published a new guidance document titled Guidance for Industry and FDA Staff Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007. This guidance document provides details including who should register with FDA and how to do it, how to list medical devices with FDA, who needs to pay user fees and how payments can be made, and how to make the applicable registrations electronically. This useful FDA guidance document can be downloaded from here.

Regards
S. Subramaniam
 

Attachments

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA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M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
M Informational FDA draft guidance – Safer Technologies Program for Medical Devices Medical Device and FDA Regulations and Standards News 0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 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M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0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 Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
Ed Panek Website to ask FDA for guidance in Medical Device Industry? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
shimonv Summary of FDA Guidance on “Medical Device Accessories” (Dec 2016) Other US Medical Device Regulations 1
M IEC 62304, ISO 14971 and FDA Medical Device SW Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Marc FDA Issues Guidance On Cybersecurity of Medical Devices Other Medical Device and Orthopedic Related Topics 1
A FDA Medical Device Reprocessing Guidance - Validation US Food and Drug Administration (FDA) 6
R FDA's guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies Other US Medical Device Regulations 3
R FDA released three guidance documents for Medical Devices - August 2014 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A FDA guidance for MDDS, Medical Images Storage, Medical Image Communications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
Ajit Basrur FDA issues Final Guidance on Mobile Medical Apps (Applications) US Food and Drug Administration (FDA) 2
A FDA Guidance for Risk Management for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Y New Draft FDA Guidance for Applicability of GLP in Medical Device Submission Other US Medical Device Regulations 2
D FDA Guidance on Interim Use of ISO13485 for Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
Ajit Basrur FDA Guidance - Heparin for Drug and Medical Device Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
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
A Guidance on Cleaning & Sterilization of an FDA Class II Medical Device US Food and Drug Administration (FDA) 4
L Interpretation of MDR Reportable Event - FDA guidance on Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
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 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 Draft Guidance – Clinical Decision Support Software 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 – 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 – 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 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
S Sterilization Site Move - Dec 2018 FDA Guidance Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
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
Ronen E FDA News FDA issues guidance on bench testing in premarket submissions Other US Medical Device Regulations 0
M FDA Guidance - general wellness products - wearables Other Medical Device Related Standards 3
M Informational USFDA draft guidance – Nonbinding Feedback After Certain FDA Inspections of Device Establishments Medical Device and FDA Regulations and Standards News 0
D FDA filing guidance to add sterilization step for approved drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
Ajit Basrur FDA News FDA Guidance Document: Manufacturing Site Change Supplement US Food and Drug Administration (FDA) 0
M Medical Device News FDA Guidance - UDI: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Other US Medical Device Regulations 0

Similar threads

Top Bottom