FDA News US FDA – November 2018 510(k) Clearances

Marcelo

Inactive Registered Visitor
#1
List of November 2018 510(k) clearances. With the recent suggestions by FDA management on future changes of the 510(k) process, keeping up-to-date with clearances (and potentially predicate devices) is even more important than ever.

Lista de Novembro 2018 de 510 (k) clearances. Com as recentes sugestões da administração da FDA sobre futuras mudanças do processo 510(k), manter-se atualizado com as clearances (e dispositivos predicados potenciais) é ainda mais importante do que nunca.

Continue reading...
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
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) 4
P Biocompatibility testing ISO-10993 for FDA submission Other Medical Device Related Standards 7
Ed Panek FDA Submission Question US Medical Device Regulations 2
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
Ed Panek Consultant Request SaMD AI "Expert" FDA US Food and Drug Administration (FDA) 2
Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
shimonv FDA-recognized Standards US Food and Drug Administration (FDA) 0
R FDA ECG Data Requirements Medical Information Technology, Medical Software and Health Informatics 3
L Language of quality system in case of FDA inspection US Food and Drug Administration (FDA) 1
M Can you import medical device not FDA approved into the USA under an IND application? US Food and Drug Administration (FDA) 2
Ed Panek FDA Submits to White House Plan to Harmonize with ISO 13485 US Medical Device Regulations 2
Melissa Contract Mfg--to Manufacturer with the FDA ISO 13485:2016 - Medical Device Quality Management Systems 4
Ed Panek ANNUAL FDA Registration - What 510(k) number to use? US Food and Drug Administration (FDA) 1
Y FDA vs (EU) 2021/2226 Electronic Instructions for Use (eIFUs) US Medical Device Regulations 1

Similar threads

Top Bottom