Intravascular Medical Devices: Lubricious Coating Separation

OMEDtechNews & Events

For over 20 years lubricious coatings have offered patients the opportunity to have Announcementless 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 of the fact that if proper precautions are not taken the coating may come off of the medical devices and cause harm to patients.  Serious adverse injuries and reactions include “pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, persistence of coating fragments in patients, adverse tissue reactions, thrombosis, and death.” (FDA)

Some tips to avoid coating separation:

  • Use the device properly according to design and label indications
  • Follow proper device storage
  • Ensure there is sufficient room when using two devices together
  • Follow any recommended preconditioning steps
  • Be cautious when moving the device through other devices with sharp edges
  • Avoid trying to alter the shape of the device
  • Replace a device is it appears damaged or does not work properly

For more information about lubricous coating separation see the FDA safety communication.

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 life-sustaining medical devices, and extensions granted to class III labelers to October 24, 2015.
For more information on UDI or GUDID:

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 export:shippingcertificate 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 the years.  In order to keep the program self-sustaining, an updated formula is being used to calculate the certificates issued and raising the fee for subsequent certificates.  For more information about medical device export certificates:

Unique Device Identification: Direct Marking of Devices – Draft Guidance Overview

OMEDtechDraft Guidance

The Unique Device Identification: Direct Marking of Devices draft guidance has been released by the FDA.  A UDI is required to be directly marked onto a device if it is “intended to be used more than once and reprocessed before each use.” (FDA)  Directly marking a UDI on reprocessed devices helps to maintain accurate information and keeps the UDI in contact with the device when it is separated from packaging.  The reprocessing of reusable devices typically involves processing, cleaning, and disinfection/sterilization.
Upcoming UDI compliance dates:
  • September 24, 2015 – UDI labeling and GUDID submission for Class I, Class II and unclassified implantable, life-sustaining or life-supporting devices
  • September 24, 2015 – All life-sustaining or life-supporting devices have a UDI direct mark

Electronic Medical Device Reporting

OMEDtechNews & Events

eMDR1Electronic 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 Safety Reports (HL7 ICSR). Both of these submission options are processed through the secure FDA Electronic Submission Gateway (ESG). Manufacturers and importers should register for an ESG account and complete a test submission to make sure no problems are encountered when making an actual submission. Test submissions will be available beginning on June 29, 2015.

Helpful links for eMDR:
HL7ICSR implementation package
Electronic Submissions Gateway
FDA eSubmitter
Health Level 7 Individual Case Safety Reports
eMDR Guidance

AccessGUDID Open for Public Use

OMEDtechNews & Events

websiteAccessGUDID is now open for public use.  The FDA has released data for devices with unique device identifiers (UDI) to the public through a website called AccessGUDID.
The FDA’s final guidance in 2013 explains the UDI purpose and requirements.  A UDI must be included on most device labels and packages, and device identification information must be submitted to the FDA’s Global Unique Device Identification Database (GUDID).
The UDI system is being implemented over several years, beginning with the highest risk medical devices and continuing until the records of all medical devices required to have a UDI are included.  Through AccessGUDID, the public can search device identification and important safety information that labelers have submitted about their medical devices to the GUDID.
For more information about UDI, GUDID, and AccessGUDID, or to view UDI training modules, visit the FDA’s UDI webpage.

Procedures for Meetings of the Medical Devices Advisory Committee

OMEDtechDraft Guidance

meetingThe CDRH issued the Procedures for Meetings of the Medical Devices Advisory Committee draft guidance on April 1, 2015.  This draft guidance explains the processes for meetings of the Medical Devices Advisory Committee panels.  Panel meetings provide an opportunity for addressing scientific, clinical, or public health issues.

Medical Device Advisory Committee Panels functions:

  • Panels may give expertise for medical device premarket submissions under review.  CDRH will use panel review for submissions such as: premarket notifications, de novo requests and humanitarian device exemptions.
  • The CDRH may use a committee panel for advice on regulatory actions on a specific device type including general scientific matters or medical device safety and effectiveness.
  • The FDA is required to seek a panel’s input as part of the classification of a preamendments device or as part of the process to reclassify a device.

Panel Meetings Process Highlights:

  • All panel meetings are announced in the Federal Register. Relevant information may be submitted via before the panel meeting.
  • Premarket Submission Panel Pack may include: FDA’s agenda, FDA’s Executive Summary, FDA’s questions for panel consideration, Sponsor’s Executive Summary, sections from the submission, information from the FDA, and information from the sponsor.
  • Regulatory Issues Panel Pack may contain: FDA’s agenda, FDA’s Executive Summary, and FDA’s questions for the panel.
  • During Premarket Submission panel meetings the sponsor should generally be provided 60 minutes to present information to the panel.  Industry stakeholders who request time to speak in advance will generally have a 60 minute presentation slot.
  • CDRH presents regulatory background information and its review of the scientific and/or clinical information for which panel input is requested. FDA typically presents the scientific and/or regulatory view of any issues and ask for guidance from the panel regarding FDA’s questions.
  • All advisory committee meetings must include a minimum of 60 minutes dedicated to an open public hearing session.
  • Approximately one hour should be designated for general panel deliberations, after which CDRH should ask the specific questions to the panel.
  • A member must be present to participate in voting.  All voting should be conducted in public view. The formal voting process is typically used for specific device marketing submissions. For Regulatory Issue meetings involving classifications or reclassifications, guidance documents, and other general issues brought to panel, the panel should be asked to discuss the issues and provide recommendations on questions asked by CDRH. For PMA meetings, the panel is typically expected to respond to three questions relating to: safety, effectiveness, and benefit versus risk for specific devices that are the subject of a PMA application.
  • Teleconference panel meetings will generally be brief. These meetings are authorized to confirm the recommendations from a previous open panel meeting or where time does not permit a meeting to be held at a central location.

Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings

Guidance for Industry Advisory Committee Meetings – Preparation and Public Availability of Information Given to Advisory Committee Members

Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers

Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees

Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures at Advisory Committee Meetings

Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings – Draft

CDRH Appeals Process

MDDS, Medical Image Storage Devices, & Medical Image Communications Devices Final Guidance


medicaldeviceThe Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices final guidance has been released. The FDA posted a regulation down-classifying Medical Device Data Systems (MDDS) from Class III to Class I on February 15, 2011. Class I devices are subject to general controls under the FD&C Act. A draft guidance regarding MDDS was issued on June 20, 2014. On February 9, 2015 the FDA released the final guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. This guidance explains the FDA’s position on the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices.

An MDDS is a hardware or software product that transfers, stores, converts formats, and displays medical device data. An MDDS does not change the data, does not control a connected medical device, and does not include devices used for active patient monitoring. A medical image storage device provides electronic storage and retrieval for medical images. A medical image communications device provides electronic transfer of medical image data between medical devices. Read more here on how the FDA classifies a medical device.

Devices that meet these definitions are a low risk to patients and they can greatly advance digital health. Therefore, the “FDA will not enforce compliance with regulatory controls, registration and listing, premarket review, postmarket reporting, and quality system regulation to MDDS devices, medical image storage devices, and medical image communications devices.”