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
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
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Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0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
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
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
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