OMEDtechNews & Events

The UDI final rule states that information about a device with a UDI must be submitted to the Global Unique Device Identification Database (GUDID). The GUDID is a public database organized by the FDA and will be a reference tool for devices with a UDI. This database will use only the DI (device identifier) portion of the UDI to identify devices.

“The GUDID provides two options for submission of device identification information: GUDID Web Interface – enables structured input of device information as one DI record at a time and HL7 SPL submission – enables submission of device information as xml files.” (FDA) To submit device identification information you must have a GUDID account. In the beginning submissions will be open only “to labelers of currently marketed class III medical devices and devices licensed under the Public Health Service Act.”   (FDA)

To request a GUDID account:

–      Select one of the submission options available – GUDID Web Interface or HL7 SPL xml file submission.

–      Identify the DUNS Number(s) to be used to represent your GUDID account.

–      Ensure the organization name and address associated to the DUNS number is correct.

–      Identify individuals for the various user roles in GUDID.

–      Submit a GUDID New Account Inquiry.

–      The FDA UDI Help Desk will email you the GUDID Account Request document.    

The public will be able to obtain information from the GUDID. They will be able to search and receive information about a device from a secure web interface or do a system to system search through a web service. Currently the GUDID is not accessible as they are waiting to gather more data.

For more information read the GUDID Guidance.

To read further information from the FDA click here.

Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies

OMEDtechNews & Events

The FDA has released its final guidance on Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies.  It aims to encourage medical device innovation in the US and improve patient care and safety as well as a patient’s access to clinical trials and treatments.  This program will create a more collaborative approach between inventors, developers, investigators, and regulators and will provide the earliest patient access to medical devices.  Early Feasibility Study (EFS) will have a small number of subjects and will be for a device that is intended for a specific indication that may be early in development and does not necessarily involve the first clinical use of a device.

According to the FDA, “This guidance outlines new policy regarding the application for and approval of early feasibility study IDEs. Two important elements of the guidance are:

  1. FDA approval of an early feasibility study, including some first-in-human studies, may be based on less nonclinical data than would be expected for other types of studies (e.g., traditional feasibility or pivotal).
  2. The introduction of new approaches to facilitate timely device and clinical protocol modifications during an early feasibility study, while still maintaining compliance with FDA human subject protection requirements, including obtaining informed consent and Institutional Review Board (IRB) (or ethics committee) oversight.” (FDA)


Approval of an early feasibility study IDE may be based on less nonclinical data.  Conducting an early feasibility study under an IDE also requires a report of prior investigations and an investigational plan.  “To improve the likelihood of IDE approval, the following questions should be addressed with supporting information in the original early feasibility study IDE application:


1. What is the clinical condition to be treated or assessed by the device?

2. What is the standard of care for the clinical condition and expected clinical outcomes associated with the standard of care?

3. What are the anticipated benefits associated with use of the study device?

4. Is the information included in the Report of Prior Investigations adequate to support initiation of the study?

5. Does the Investigational Plan include a thorough risk analysis, sufficient risk mitigation strategies, adequate human subject protection measures, and an appropriate clinical study protocol?

6. Are the potential risks associated with the device use likely to be outweighed by the anticipated benefits of the early feasibility study, that is, is initiation of the clinical study justified based on the clinical need for the device, Report of Prior Investigations and Investigational Plan?” (FDA Guidance Section 5)


Overall, this program will create the ability to “obtain clinical experience with a new or modified device or new clinical use, while utilizing appropriate subject protection measures and good clinical study practices. Vital clinical information can be captured and used to optimize the device design, design evaluation, and clinical investigation plans.” (FDA)


To read the full guidance click here.


BSI Associate Consultant Program

OMEDtechNews & Events

OMEDtech has been accepted into BSI’s Associate Consultant Program.  While BSI does not endorse the services of ACP members it does “prescreen and approve members that have demonstrable experience with respect to specific management systems standard(s) where they have the competence to deliver consultancy services.”   We are excited to have the opportunity to participate in this program.

OMEDtech LLC US 042_Highres


OMEDtechNews & Events

The FDA has announced that beginning in January 2014 they will begin participating in the MDSAP (Medical Device Single Audit Program). The goal of the program is “to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.”

They will join international groups from Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, and Observers – Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency. MDSAP audit reports will suffice in place of routine FDA inspections.

Here is the full MDSAP Pilot announcement.


FDA Final Guidance on Mobile Medical Apps

OMEDtechNews & Events

Mobile Medical Applications

The number of mobile applications and users are growing every day.  Included in this expanding technology is the category of mobile medical applications. “Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.” (FDA) The technology for these apps is growing quickly and the FDA wants to ensure that proper safety measures are in place and followed to protect the public.  On September 25, 2013 the FDA released its final guidance for mobile medical applications.

Mobile Medical App Regulation

The FDA is using discretion when choosing which of these apps need review.  Many of the mobile medical apps will not be regulated by the FDA.  The FDA will not regulate mobile apps that do not qualify as a medical device or apps that are considered a low risk medical device. The FDA intends to show discretion for mobile medical apps which:

  • “Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;
  • Provide patients with simple tools to organize and track their health information;
  • Provide easy access to information related to patients’ health conditions or treatments;
  • Help patients document, show, or communicate potential medical conditions to health care providers;
  • Automate simple tasks for health care providers; or
  • Enable patients or providers to interact with Personal Health Record or Electronic Health Record systems.”

Instead, the FDA will be regulating apps that meet their definition of a medical device and pose a risk to a patient’s safety if they do not function properly.  They will regulate apps that “are intended to be used as an accessory to a regulated medical device…or transform a mobile platform into a regulated medical device.” Here are some examples of what type of mobile medical app the FDA regulates.

  • Mobile apps that transform a mobile platform into a regulated medical device and therefore are mobile medical apps: These mobile apps use a mobile platform’s built-in features such as light, vibrations, camera, or other similar sources to perform medical device functions
  • Mobile apps that connect to an existing device type for purposes of controlling its operation, function, or energy source and therefore are mobile medical apps: These mobile apps are those that control the operation or function (e.g., changes settings) of an implantable or body worn medical device.
  • Mobile apps that display, transfer, store, or convert patient-specific medical device data from a connected device and therefore are mobile medical apps:

Mobile Medical App Developers

“The FDA strongly recommends that manufacturers of all mobile apps that may meet the definition of a device follow the Quality System  regulation (which includes good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm.”

If the app you are developing requires regulation by the FDA the manufacturer must comply with the proper requirements for the device’s classification.  Developers should contact the FDA with questions about the process.  A mobile medical application is considered a medical device and as such would be responsible for following the policies associated with that classification.

For the full FDA Guidance document read:

UDI Final Rule

OMEDtechNews & Events

UDI Final Rule

The FDA released their final rule for UDI on September 20, 2013.  Most medical devices will require a UDI or Universal Device Identifier.  The UDI will have many benefits such as improved product information and faster product identification for problems or recalls.  The UDI is a unique code made up of two parts.  The DI is the device identifier which is mandatory and identifies the labeler and specific version or model.  The PI is the product identifier which is a conditional part of the code identifying items such as lot number, serial number, expiration date, manufacture date, etc.


Compliance and Exemptions

There are different compliance dates depending on which category your device falls into.  High risk devices must comply first and then they phase through lower risk categories. Class III devices must comply with the new rule within a year of final passing, implantable devices that are life-sustaining or life-supporting that are not Class III devices must comply within two years, Class II devices must comply within three years, and Class I devices must comply within five years.


There are several exceptions to the compliance rules. “ Section 801.30(a)(1) of the final rule provides an exception for a “finished device manufactured and labeled prior to the compliance date that applies” to the device, but this exception “expires with regard to a particular device 3 years after the compliance date that applies” to the device.”  If a device is not yet completed or has not been labeled the exception will not apply.


Requirements for a UDI

The UDI must be issued by an accredited agency. The FDA does not indicate which type of AIDC technology you must use and will accept identifiers that are part of the ISO 15459 series of standards. Manufacturers must then submit the device data to the FDA Global UDI Database (GUDID) and update data such as the manufacturer and contact information, a version number of the device, etc. when necessary.  The data will be made available to the public so that users of a medical device can access information about their device.


Accredited Issuing Agencies

The FDA is in the process of approving accredited issuing agencies.  The FDA states, “We believe the UDI system will be best served if qualified private organizations that have relevant experience operate the day-to-day technical aspects of the UDI system. In addition, we have removed the provision that would have allowed a State agency to serve as an issuing agency. Although FDA may act as an issuing agency if it is necessary or appropriate for us to do so.”  The FDA will announce decisions on issuing agencies as they become available.


Things to consider

Here is a brief look at what to consider now that the FDA has finalized the UDI rule.

  • Ascertain which of your devices require a UDI and which ones will have to comply first.
  • Be aware of all of your compliance deadlines and exemptions.
  • Choose a standard.  The FDA  will accept identifiers that are part of the ISO 15459 series of standards.
  • Determine if your label must be placed directly on the product or onto the packaging.
  • Check your current packaging/product and evaluate how it may need to change to adapt to the requirements of the UDI.
  • Assess how the UDI will affect your manufacturing and/or packaging procedures.


For a general overview of the UDI rule and compliance dates:

To read the information on the FDA’s final UDI rule:


MedVentures Conference

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OMEDtech attended the MedVentures Conference in Dallas, on October 10, 2012.

David Makanani at the OMEDtech booth

MedVentures is an early-stage investment and education conference focusing on the rapidly growing medical technology sector. The medical technology sector includes medical devices and instruments, diagnostic equipment, medical therapeutic devices, medical monitoring equipment and other health-related products and services.