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
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
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 5
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 3
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
K FDA - Can we have more than 1 Initial Importer Medical Device and FDA Regulations and Standards News 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 12
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 7
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

Similar threads

Top Bottom