Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices?

C

chloep17

#1
#1
Good Morning,

Does anyone have any information on whether it is required that the lab used for 510k bio-compatibility testing is FDA recognized?

Many thanks.
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
Parul Chansoria

Parul Chansoria

Founder, Elexes Medical Consulting
#3
#3
For a 510(k), carrying out the biocompatibility testing in an FDA-recognized lab is not mandatory; rather, the test lab that performs biocompatibility tests must be in accordance with the FDA-recognized ISO 10993 standard, and they must use Good Laboratory Practices (GLP), 21 CFR 58 as applicable, and have AAALAC accreditation or another similar animal welfare certification. The US FDA will only accept test results from laboratories that fulfill these criteria.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
shimonv FDA-recognized Standards US Food and Drug Administration (FDA) 0
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Medical Device and FDA Regulations and Standards News 0
L Device Labeling - Stand Alone Symbols of ISO15223 no longer FDA recognized Other US Medical Device Regulations 2
A List of FDA recognized standards for medical devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M FDA Acceptance of ISO 13485 Reports from a Recognized International Program Other US Medical Device Regulations 4
Q FDA - Modifications to the List of Recognized Standards: List Number 026 US Food and Drug Administration (FDA) 1
J Use of FDA recognized standards: IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
M Recognized Symbols for Device Labeling? 510k to the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
G FDA requirements for risk analysis US Food and Drug Administration (FDA) 2
V Anyone have templates for FDA GMP Guidelines for supplement manufacturers? US Food and Drug Administration (FDA) 0
N FDA mechanical bench testing Manufacturing and Related Processes 5
V Regulatory consultants for US FDA ANDA - pharma / drug products Consultants and Consulting 0
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
S Is it possible to obtain FDA clearance (510k) without meeting QSR? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P Biocompatibility testing ISO-10993 for FDA submission Other Medical Device Related Standards 7
Ed Panek FDA Submission Question US Medical Device Regulations 3
Y The day after the FDA US Food and Drug Administration (FDA) 2
U FDA foreign inspection and COVID19 US Medical Device Regulations 4
Y Convenience pack FDA US Food and Drug Administration (FDA) 3
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
N FDA medical devices US Food and Drug Administration (FDA) 1
R US FDA 510k Australia TGA US Food and Drug Administration (FDA) 0
B How FDA define a new variant/generation or a new device US Medical Device Regulations 11
G FDA Annual Registration and Listing US Food and Drug Administration (FDA) 7
T Book Excerpt: Drugs and the FDA: Safety, Efficacy, and the Public’s Trust Book, Video, Blog and Web Site Reviews and Recommendations 0
E The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
P Looking for Korean FDA Drug Master File requirements for packaging systems. Other Medical Device and Orthopedic Related Topics 1
M IEC 62366 Hazard-related Use Scenario vs FDA Critical Task EU Medical Device Regulations 3
N Free sale and FDA US Food and Drug Administration (FDA) 1
N FDA class 1 US Food and Drug Administration (FDA) 6
G UDI in EU vs FDA EU Medical Device Regulations 1
S Initial Audit FDA US Medical Device Regulations 3
T FDA PMA review process - advisory panel timing? Other Medical Device and Orthopedic Related Topics 0
E FDA & Internal Audits US Medical Device Regulations 3
N Importing into US without 510K/FDA Clearance US Medical Device Regulations 1
N FDA class 2 Device QS Requirements US Food and Drug Administration (FDA) 2
T FDA labeling requirements US Food and Drug Administration (FDA) 2
S FDA Contract Manufacturer and Applicant US Food and Drug Administration (FDA) 0
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 13
K Change in address on ERLM US FDA: Implications to import US Medical Device Regulations 0
V FDA 510K - Pre Submission Query US Food and Drug Administration (FDA) 6
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
T Link GMDN code and FDA product code US Medical Device Regulations 5
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
K Non-Device MDDS Clarifications (FDA) US Food and Drug Administration (FDA) 7

Similar threads

Top Bottom