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Unique Device Identifier Convenience Kit Draft Guidance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The FDA has released a draft guidance: Unique Device Identifier Convenience Kit.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

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

eCopy Program for Medical Device Submissions

OMEDtechGuidance

Certain medical devices must provide an electronic copy (eCopy) of their submission.   An eCopy is a duplicate of the paper copy that is submitted to the FDA, and may be submitted on a CD, DVD, or flash drive.  The purpose of an eCopy is to improve the review process by making a submission available immediately.  The updated guidance document “eCopy Program for Medical Device Submissions” was … 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