Final guidance for 510k/ de novo submission of nucleic acid based multiplexed IVDs

rangani_rj

Involved In Discussions
#1
Hi all,

As global market of DNA based IVDs is expected to reach 20 Billion by 2020, this new guideline may help developers of such kind of IVDs.

Guidance provides detailed recommendations (analytical and clinical performance) to be included for 510 (k)/ de novo submission of nucleic acid-based (DNA/RNA) multiplexed IVDs (detecting ≥20 different organisms/targets (drug resistant marker) in a single reaction from single specimen/culture) using polymerase chain reaction (PCR), reverse-transcriptase polymerase chain reaction (RT-PCR), bead-based liquid arrays, microarrays, re-sequencing approaches etc (21 CFR 862.2570).

It is not intended for IVDs that utilize detection mechanisms other than nucleic acid based approaches, like IVDs to screen donors of blood and blood components, and donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) for communicable diseases.
 

Attachments

Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: Final guidance for 510k/ de novo submission of nucleic acid based multiplexed IVD

A Quick Bump!

In case you missed this post + attachment.
 
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 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
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 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 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 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
bio_subbu USFDA issues final guidance on "Reprocessing Medical Devices in Health Care Settings" Other US Medical Device Regulations 1
R Final guidance - FDA Decisions for IDE Clinical Investigations 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
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
sagai Mobile Medical Applications Final Guidance Released Other US Medical Device Regulations 0
W FDA's final guidance for Mobile App will final in coming weeks. Medical Information Technology, Medical Software and Health Informatics 0
bio_subbu CDSCO Issues final guidance documents on Registration & Import of Medical Devices Other Medical Device Regulations World-Wide 0
Gert Sorensen 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
Y Final Guidance - Exception From Informed Consent for Emergency Research US Food and Drug Administration (FDA) 4
L AS 9100 Rev.C guidance for the final exam Training - Internal, External, Online and Distance Learning 2
bio_subbu USFDA issues Final Guidance Document on InVitro Diagnostic Device (IVD) Studies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
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 and update guidances – Software Medical Device and FDA Regulations and Standards News 2
V Removing final inspector for medical device manufacturing Lean in Manufacturing and Service Industries 4
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
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 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 Report – MDUFA IV Independent Assessment of FDA’s Device Review Process Management Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom