When Do I Call It Rework?


By Melissa Glass When do I call it a rework? Several variables distinguish a rework from a repair or nonconformance. This can mean many things as applied to business, lean Six Sigma operations, pharmaceutical or medical device manufacturing. Is it a nonconformance? Nonconformance occurs when a device does not meet a specific requirement. In medical device manufacturing, nonconformance is an umbrella that captures … Read More

GUDID Update – Premarket Submission Supplement Number

OMEDtechNews & Events

GUDID Enhancements The GUDID system will soon undergo enhancements.  These improvements will allow the system to continue meeting user and program needs. The GUDID Release 2.3 will include the public release of the Premarket Submission Number and the Supplement Number which will become part of each GUDID DI record. Before the GUDID enhancements are implemented, the FDA suggests that users … Read More

FDA Gives UDI Extension for Low-Risk Medical Devices

OMEDtechNews & Events

FDA Issues Letter to UDI Device Labelers The FDA has provided a notice to device labelers with an update on the Unique Device Identification (UDI) compliance dates. Originally, the UDI was to be marked on labels at different time frames with regard to the classification level of the device. The FDA has extended UDI compliance dates for certain types of … Read More

FDA Regulatory Guidelines for ENDS

OMEDtechNews & Events

A rule has been passed that gives the FDA regulatory authority over most aspects of ENDS products.  The new rule allows the FDA to regulate all ENDS, including: vaporizers, vape pens, hookah pens, E-Cigarettes, e-pipes, and all other ENDS.  These regulations cover everything from the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. The new regulation encompasses components of … Read More

Health Canada Transition to MDSAP

OMEDtechNews & Events

Health Canada has announced that they are in the process of changing from CMDCAS to MDSAP for medical device manufacturers to sell products in Canada.  The Medical Device Single Audit Program (MDSAP) pilot is ongoing and was created to have a single audit meet the quality management system requirements of multiple agencies based on ISO 13485:2003.  The switch to MDSAP … Read More

Unique Device Identifier Convenience Kit Draft Guidance

OMEDtechDraft Guidance

The FDA has released a draft guidance: Unique Device Identifier Convenience Kit.  This document further explains the phrase “convenience kit” and how it applies to the UDI rule.  The FDA released their final rule for UDI on September 24, 2013, requiring most medical devices to label a UDI.  The UDI will have many benefits such as improved product information and … Read More

Mobile Medical Device – Interactive Tool

OMEDtechNews & Events, Uncategorized

There are more and more mobile health apps created every day.  Mobile medical devices and health apps must follow federal laws that apply to their product. The FTC has worked with the FDA, ONC, and OCR to release an interactive tool which will help mobile app developers understand which federal laws apply to their products. The user is able to … Read More