FDA UDI Class I Compliance Date Extended

D

dipo9

#1
Hello,

I just learned today, 6/2/17, that the FDA issued a letter upon its web site extending the compliance date for lower-risk medical devices.

Class I devices: compliance date is now September 24, 2020.

You can read the letter upon the FDA's web site where the compliance dates for UDI requirements are listed. Hope this helps a lot of other folks now that we have more time!:bigwave:
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19
M Medical Device News FDA Guidance - UDI: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Other US Medical Device Regulations 0
Q US FDA UDI Compliance Question - Class II (Special Controls) Other Medical Device and Orthopedic Related Topics 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
N Will an FDA UDI be compatible with a European MDR UDI? EU Medical Device Regulations 7
M FDA UDI with Multiple Packaging Configurations Other US Medical Device Regulations 3
Pmarszal FDA Global UDI Database: Record Submission Retention Other US Medical Device Regulations 1
Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0
bio_subbu FDA issues Guidance on UDI - Frequently Asked Questions, Vol. 1 Other US Medical Device Regulations 1
bio_subbu FDA issues Small Entity Compliance Guidance for UDI Other US Medical Device Regulations 1
K UDI (Unique Device Identification) requirements of US FDA US Food and Drug Administration (FDA) 4
L New Website from the FDA concerning UDI Exceptions, Alternatives and Time Extensions Other US Medical Device Regulations 0
Ajit Basrur ICCBBA Is Now an FDA-Accredited Issuing Agency for Unique Device Identifiers (UDI) Other US Medical Device Regulations 1
Sam Lazzara 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015) Other US Medical Device Regulations 45
X FDA UDI (Unique Identification) amendment on 19 Nov 2012 - Date of 'final rule'? US Food and Drug Administration (FDA) 4
K Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary: Other US Medical Device Regulations 12
S US FDA Unique Device Identification (UDI) Proposed Rule 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
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
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
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
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