FDA Establishment Registration Foreign Manufacturer RUO only

#1
We are going to distribute a foreign company's Chemilumenisent and ELISA analyzer which is an instrument and the intended use is for Research-Use-Only (RUO). So for a device that is for RUO, does this foreign manufacturer need to setup the FDA Estabishment Registration, and pay annual fee?

From FDA's definition for Foreign establishments, it appears it is not required if it's for RUO? The page says it is required if for health-related purpose commercial distribution
Who Must Register, List and Pay the Fee
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
S Is FDA Establishment Registration required for clinical manufacturing ? US Food and Drug Administration (FDA) 3
S FDA Establishment Registration for Testing Laboratories 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Is FDA Establishment Registration for Bulk packaging Contract Manufacturers ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B How does a Kit Assembler proceed after FDA Establishment Registration? Other US Medical Device Regulations 3
E FDA guidance on Foreign establishment registration US Food and Drug Administration (FDA) 3
J Establishment registration FDA 'Foreign exporter' 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Initial Registration of an Establishment with FDA US Food and Drug Administration (FDA) 5
S Training on FDA "Establishment Registration" US Food and Drug Administration (FDA) 2
B FDA - New Establishment Registration and Device Listing Requirements Other US Medical Device Regulations 14
R Do we need FDA Establishment Registration for Bone Screws? US Food and Drug Administration (FDA) 21
D FDA Establishment Registration for Software Company US Food and Drug Administration (FDA) 8
bio_subbu US FDA Guidance on Medical Device Establishment Registration and Listing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q FDA: File an electronic Registration of Drug Establishment/Labeler Code 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ajit Basrur Change in FDA Establishment Registration Fee process wef Oct 1, 2008 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
B New FDA Forms - 2891 Registration of Device Establishment, FDA 2892 Device Listing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Q FDA Establishment Registration - Does registration require compliance to the QSR? ISO 13485:2016 - Medical Device Quality Management Systems 8
S FDA Facility Establishment Identifier (FEI) question US Food and Drug Administration (FDA) 7
F Obtaining copies of FDA Establishment Inspection Report US Food and Drug Administration (FDA) 8
R Ownership of FDA registered establishment changing - what to do? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 2
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
P Choice of FDA reviewer US Food and Drug Administration (FDA) 6
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 6
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Watchcat FDA Webinar Series - N95 Respirators Other US Medical Device Regulations 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3

Similar threads

Top Bottom