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

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

CDRH Research Programs

OMEDtechNews & Events

CDRH Research Programs provide users with a wealth of information covering a variety of topics and clinical areas.  The CDRH has released a new webpage providing more information on its Research Programs.  The new webpage allows users to search research by special topic or by clinical area, including: Anesthesiology, General Hospital, Respiratory, Infection Control, Dentistry, Cardiovascular, Neurology and Physical Medicine, Orthopedics, … Read More

Intravascular Medical Devices: Lubricious Coating Separation

OMEDtechNews & Events

For over 20 years lubricious coatings have offered patients the opportunity to have less invasive procedures.  Medical devices used during procedures in the cerebrovascular, cardiovascular, and peripheral vascular systems often have hydrophilic and/or hydrophobic lubricious coatings to reduce friction, which creates better maneuverability and less trauma to the blood vessels.  Although the coating is very beneficial the FDA wants health care providers to be aware … Read More