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

GUDID Data Submission Compliance Update

OMEDtechNews & Events

The unique device identification (UDI) rule is being implemented by device classification, with varying compliance dates to the Global Unique Device Identification Database (GUDID).  The GUDID system was temporarily taken offline on August 7, 2015 for security reasons.  Since the system was unavailable the FDA has decided to extend the September 24, 2015 compliance date for the implantable, life-supporting and … Read More

Medical Device Export Certificates

OMEDtechNews & Events

Exporting medical devices from the United States often requires a certificate for products regulated by the FDA. An export certificate gives information from the FDA on the product’s regulatory status.  The FDA has revised medical device export certificates fees for the second time since the program began in 1996.   Medical device export certificate processing costs have gone up over … Read More

Electronic Medical Device Reporting

OMEDtechNews & Events

Electronic Medical Device Reporting (eMDR) requires medical device manufactures and importers to submit medical device reports (MDRs) in an appropriate electronic format so the information can then be processed, reviewed, and archived by the FDA. The eMDR final rule will be effective on August 14, 2015. There are two options for submitting eMDRs: eSubmitter or Health Level 7 Individual Case … Read More