FDA News FDA guidance on Multiple Function Device Products (8/2020)

GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#2
#2
Hmm... I was following along fairly well until they got to the examples. How is a computing platform or a WiFi card a "function"? If you display information, wouldn't this make the screen a function? (To be fair, when these 'components' could affect the system, we do consider them in risk analysis and such, but to call them functions is, um, unexpected.)

It's been a month now since that was published; I wonder if anyone has had any experience with it?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
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
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M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0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 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 – 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 – 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 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 Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program 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 5
Ed Panek Website to ask FDA for guidance in Medical Device Industry? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 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
AnaMariaVR2 Pharmaceuticals News Transdermal and Topical Delivery Systems: FDA & EMA Guidance US Food and Drug Administration (FDA) 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
shimonv Summary of FDA Guidance on “Medical Device Accessories” (Dec 2016) Other US Medical Device Regulations 1
shimonv FDA guidance on Postmarket Surveillance Other US Medical Device Regulations 1
M 2016 FDA Final Guidance for Blood Glucose Monitoring Systems - Implementation Other US Medical Device Regulations 2
M IEC 62304, ISO 14971 and FDA Medical Device SW Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Ronen E FDA releases new draft guidance on when to submit a 510(k) for device modification Other US Medical Device Regulations 10
Marc New FDA guidance on low-risk wellness devices US Food and Drug Administration (FDA) 1
Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0
planB Biocompatibility: Blue Book Memorandum #G95-1 superseded by new FDA guidance Other Medical Device Related Standards 1
Ronen E FDA issues draft guidance on additive manufacturing Other US Medical Device Regulations 1
D FDA Guidance Document for Preparing Annual Product Reviews US Food and Drug Administration (FDA) 2

Similar threads

Top Bottom