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, Surgery, Reproductive, Gastroenterology, Nephrology, and Urology, IVD, Radiology, Ophthalmology and Ear, Nose, and Throat.  These research programs provide information used in the development of “new tools, standards and approaches to assess the safety, efficacy, quality, and performance of medical devices and radiation-emitting products. (FDA)”

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 released on December 3, 2015.  Some of the changes to the guidance include: explanation of the importance of bookmarks and hyperlinks, gives details on creating a PDF file from the source document, emphasizes the use of the eCopy Validation Module and the eSubmitter-eCopies Tool.

An eCopy is required for the following submission types:

  • Premarket notification submissions
  • Evaluation of automatic class III designation petitions
  • PMAs
  • Modular PMAs
  • Product development protocols
  • IDEs
  • HDEs
  • Emergency Use Authorizations
  • Certain investigational new drug applications
  • Certain biologics license applications
  • Q-submissions

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
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.