FDA Establishment Registration for Testing Laboratories

SGquality

Quite Involved in Discussions
#1
Is it required for testing laboratories (for Microbiological analysis like Bioburden, Sterility Test etc.) to be registered with FDA for Establishment Registration ?

The subject in question is for laboratories within US.

Thank you
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
No. There is no applicable registration category.

The exception to this would be if the lab also offered services that are considered to be production steps, such as contract sterilization; or if the lab also makes finished devices of some kind.

Nelson Labs, for instance, is registered, and offers the kinds of lab services you mention, but their registration is as a contract sterilization provider.
 
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
J FDA Establishment Registration Foreign Manufacturer RUO only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Is FDA Establishment Registration required for clinical manufacturing ? US Food and Drug Administration (FDA) 3
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
H Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
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 0
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
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
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
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
D FDA De Novo Cover Letter - What is expected US Food and Drug Administration (FDA) 3
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Mislabeling - Consider this an FDA notified recall? CFR 806.10 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom