SBS - The Best Value in QMS software

FDA issues draft guidance on additive manufacturing

Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0
M FDA issues draft guidance to replace G95-1 (Application of ISO 10993) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
bio_subbu US FDA issues Draft Guidance on Premarket Approval (PMA) Acceptability Other US Medical Device Regulations 0
Ajit Basrur FDA issues draft guidance on nanotechnology US Food and Drug Administration (FDA) 1
bio_subbu FDA issues draft PMA (Pre-Market Approval) Clinical Study Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
bio_subbu FDA issues first draft guidance document on Mobile Medical Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
Ronen E FDA News FDA issues guidance on bench testing in premarket submissions Other US Medical Device Regulations 0
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
Marc FDA Issues Guidance On Cybersecurity of Medical Devices Other Medical Device and Orthopedic Related Topics 1
bio_subbu FDA issues Guidance on UDI - Frequently Asked Questions, Vol. 1 Other US Medical Device Regulations 1
bio_subbu FDA issues Small Entity Compliance Guidance for UDI Other US Medical Device Regulations 1
Ajit Basrur FDA issues Guidance Document - Benefits-Risks Factors to consider for 510(K) US Food and Drug Administration (FDA) 1
Ajit Basrur FDA issues Final Guidance on Mobile Medical Apps (Applications) US Food and Drug Administration (FDA) 2
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
Ajit Basrur FDA issues Warning Letters for misleading advertising of Lap-Band US Food and Drug Administration (FDA) 3
Ajit Basrur FDA issues 2 Guidance Documents on Nov 10, 2011 US Food and Drug Administration (FDA) 0
bio_subbu FDA Issues Guidance Document on Electrocardiograph (ECG) Electrodes Other US Medical Device Regulations 0
Ajit Basrur FDA Issues Final Regulation on Dental Amalgam 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ajit Basrur FDA Issues concerns on "e-cigarettes" US Food and Drug Administration (FDA) 4
D FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 211 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 5
B How to submit Pre-submission to FDA? US Food and Drug Administration (FDA) 4
L FDA & 21 CFR Part 11 Medical Device and FDA Regulations and Standards News 19
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
Ed Panek 2020 FDA Top Ten Observations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B FDA Breakthrough Device can be overlapped with a designated device? US Food and Drug Administration (FDA) 6
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
Watchcat FDA vs NB Fees? Other US Medical Device Regulations 7
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4
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
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4

Similar threads

Top Bottom