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 review their GUDID listings and prepare for how they may be impacted by the changes. In May 2018, the FDA plans to update GUDID so that labelers will have the opportunity to review the premarket submission number and to identify the releasability of a premarket submission number and supplement number for their GUDID listings. Premarket numbers may be kept confidential depending on their confidentiality designation.

How to Prepare

Users can review and make changes to any confidentiality designations on the Device Registration and Listing Module (DRLM). It is important to prepare for the changes by checking your GUDID records and confirming they have all relevant listing numbers and to review and/or change the confidentiality designations. The public release of premarket submission and supplement numbers will occur in June 2018.

Resources:

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 lower risk Class I and unclassified devices. This extension will allow the FDA to further develop the UDI system and gain the full potential of UDI data. The UDI label requirement for certain Class I and unclassified devices has been extended to September 24, 2020. The UDI direct mark for these lower risk devices will need to be in place by September 24, 2022. A new guidance document will be issued to provide information on the enforcement discretion for labeling, GUDID submission, standard date formatting and direct mark requirements for low-risk medical devices.

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, timehookah 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 ENDS such as: E-liquids, cartridges, atomizers, flavorings for ENDS, cartomizers, clearomizers, digital display, tank systems, drip tips, and programmable software.  If you operate a vape shop that mixes or prepares liquid nicotine or nicotine-containing e-liquids, or creates or modifies any type of ENDS, you are considered a manufacturer and must comply with all of the legal requirements for tobacco product manufacturers.

If you manufacture ENDS, these are some requirements that apply to you:
Resources:

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 regulatoryongoing 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 will take place over a two year period, beginning at the conclusion the pilot on January 1, 2017.  Throughout the transition Health Canada will accept certificates from CMDCAS and MDSAP.  Medical device manufactures who wish to sell in Canada are encouraged to make the transition to MDSAP for their next CMDCAS audit.  By January 1, 2019 Health Canada will only accept MDSAP certificates.
For more information on the Health Canada transition from CMDCAS to MDSAP see the following:

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 faster product identification for problems or recalls.  convenience kitLabelers have been complying with the label and data submission requirements, ensuring that each device has its own UDI.  For convenience kits, each individual device does not have to have a UDI as long as the main container of the kit bears a UDI.  Previously, a convenience kit included implantable devices in sets or trays that would be repeatedly used and sterilized.  The FDA has determined that this previous use of convenience kit did not fulfill the UDI rule.  The FDA currently defines “convenience kit” at 21 CFR 801.3 142 as “applying solely to two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and the individual devices within the package not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.”  Read the full FDA documents for all of the information on the UDI Final Rule or Convenience Kits.

Mobile Medical Device – Interactive Tool

OMEDtechNews & Events, Uncategorized

health appThere 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 go through a list of questions that will help to determine which laws apply to their mobile medical device or app. This interactive tool can point developers towards some of the federal regulations and laws they may need to follow.

The various groups and laws the interactive tool covers includes:

– OCR; HIPAA rules: protecting the privacy and security of applicable health information
– FDA; FD&C Act: regulates the safety and effectiveness of medical devices
– FTC; FTC Act: prohibits deceptive practices, privacy and data security, false claims about safety
– FTC; Health Breach Notification Rule: applicable businesses must provide notification of breaches of personal health record information

For more information on mobile medical devices:

– Mobile Medical Applications Guidance
– Mobile Medical Applications Website

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