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

OMEDtechGuidance

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 A draft guidance regarding MDDS was issued on June 20, 2014.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.”

General Wellness: Policy for Low Risk Devices

OMEDtechDraft Guidance

healthThe FDA has issued a draft guidance document to provide information for low risk products that promote a healthy lifestyle. CDRH defines general wellness products as products that “are intended for only general wellness use, and present a very low risk to users’ safety.”  A general wellness product must either help to maintain a general state of health, or help to reduce the risk or impact of chronic diseases when combined with a healthy lifestyle. General wellness products may include exercise equipment, audio recordings, video games, software programs and other products that meet the criteria.

There are two categories of general wellness products.  The first category of general wellness products are for sustaining or improving a person’s general state of health and do not make any reference to diseases or conditions.  These general wellness products may be for: weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function. The second category of general wellness products may help an individual to reduce risk or to live well with certain chronic diseases or conditions when combined with a healthy lifestyle.  Examples of chronic diseases include heart disease, high blood pressure, and type 2 diabetes.

CDRH does not intend to determine whether general wellness products are classified as devices or whether they comply with premarket review and post-market regulatory implementing regulations, including: “registration and listing and premarket notification requirements; labeling requirements; good manufacturing practice requirements as set forth in the Quality System regulation; and Medical Device Reporting requirements.”  CDRH’s general wellness policy does not extend to devices that are not low risk general wellness products. To begin assessing if a device is considered low risk the FDA suggests that you determine if the CDRH currently regulates similar products.

 

Read the full draft guidance here.

UDI Update

OMEDtechNews & Events

News and EventsThe FDA’s Center for Devices and Radiological Health (CDRH) has issued an update on the upcoming Unique Device Identifier (UDI) requirements.
  • September 24, 2015 for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices
  • September 24, 2016 for class II devices
Upcoming dates for Global Unique Device Identification Database (GUDID) Data Submission:
  • January 2015, they will begin accepting GUDID account requests from labelers of I/LS/LS devices.
  • Later in 2015, they plan to accept GUDID account requests from labelers of class II devices.
The CDRH has provided steps (Suggested steps are included on the UDI website) to help device labelers prepare to meet UDI requirements before actual data submission to GUDID. Following these steps will give labelers time to meet requirements and to work with the CDRH if they have problems coming into compliance.  In January 2015, the CDRH will host a webinar to help Class II and I/LS/LS device labelers prepare to comply with the UDI rule.
The CDRH plans to address several UDI issues in 2015, such as: UDI direct marking requirements, convenience kits, posting of decisions on UDI exceptions and alternatives.  They are working with the National Library of Medicine (NLM) to give the public search and download access to published records in the GUDID by the spring of 2015. The CDRH hopes to have the GUDID system  implemented over several years.  The CDRH’s “focus is getting the system implemented correctly and actively helping companies comply with system requirements.”
For more information:

UDI Extension

OMEDtechNews & Events

updateThe 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 UDI Rule gives criteria for labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the United States.  UDI compliance dates have been set by the FDA according to device category.
In August 2014, Advanced Medical Technology Association (AdvaMed) explained to the FDA in a proposal the “unique complexities and challenges for conveying UDIs on the device or device label to the point of use” for certain products.  AdvaMed gave possible solutions to maintain the correct identification of devices which become separated from their original label and package during cleaning and sterilization.
Following this proposal, the CDRH is allowing an extension of the compliance date for the UDI labeling requirements to September 24, 2016, for –
(1) Medical devices classified with primary product codes and with certain regulations.
(2) Medical devices that are single use implants.
(3) Medical devices intended to be sterilized before use.
The letter regarding the UDI extension also contains a list of extensions.
For the final UDI guidance click here.
For the AdvaMed proposal click here.
For the letter regarding UDI extension click here.

Medical Device Recall vs. Enhancement

OMEDtechNews & Events

The Distinguishing Medical Device Recalls from Medical Device Enhancements guidance addresses questions and inconsistencies that arise when making changes to a marketed device. When determining whether a change to a device is classified as a recall or enhancement, you should always carefully review all appropriate regulations. The FDA defines a medical device recall as “a firm’s removal or correction of a marketed device that the Agency considrecallers to be in violation of the laws that it administers and against which the agency would initiate legal action.”

Marketed medical devices with defects can cause serious risks to the public. The recall process is in place to properly correct device defects and to notify the public of potential risks. The medical device recall process is usually initiated and coordinated by the company. Once the recall is initiated it gets classified, monitored, and terminated by FDA and the CDRH. If there is uncertainty in the recall process there are serious delays between when the recall is identified and reported and the time in which the public is alerted of the problem.

Companies may have trouble identifying whether a change to a device meets the definition of a recall or an enhancement. New versions of a device often involve changes to device design. This does not necessarily mean that the existing device should be recalled. The changes may be considered to be a medical device enhancement and would follow a different course of action from a medical device recall.

Properly defining a change to a device as a recall or an enhancement is an important step to protecting public health. These definitions also impact the industry responsibilities and appropriate FDA oversight. For further information read the full guidance here.

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Draft Guidance

OMEDtechNews & Events

The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices draft guidance has been released to communicate the FDA’s standpoint on enforcing regulatory controls in regards to digital health efforts. The FDA understands that medical device access to digital technology has the opportunity to create more efficient and improved patient care. This draft guidance discusses how medical devices and this digital technology will work together.medical device

Medical devices and Medical Device Data Systems (MDDS) are “hardware or software products that transfer, store, convert formats, and display medical device data.” (FDA) A MDDS does not change data, control any part of the connected medical device, and cannot be used with active patient monitoring. Mobile apps within the proper parameters will be categorized as MDDS. Medical Device Data Systems, Medical Image Storage Device, and Medical Image Communications Devices draft guidance also states that the FDA does not anticipate enforcing “compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting and quality system regulation for manufacturers of these types of devices.” (FDA)

Balancing Premarket and Postmarket Data Collection

OMEDtechNews & Events

orange dataThe FDA is working to make the premarket review process more efficient. This draft guidance explains how the FDA plans to balance premarket and post-market data collection while still maintaining a high standard of safety. Finding the right balance of data collection will provide patients with faster access to new technology without compromising device or patient safety.

In some cases, the FDA may enforce postmarket requirements to a PMA application, such as continuing evaluation and reporting on the safety, effectiveness, and reliability of a device. The postmarket data will allow the FDA to continue assessment of the risks and benefits of a device with more certainty and to address concerns regarding the safety or effectiveness of a device. “The FDA recognizes that medical device approvals are not made with absolute certainty due to significant obstacles, such as the time and cost involved to address possible rare adverse events or long-term safety and because clinical studies do not fully represent how a device will be used in clinical practice.”
The FDA may approve a device with more uncertain risks if the device has probable benefits and more postmarket controls are in place. Post-approval studies may collect data on adverse events for which there was limited knowledge during premarket review, and review of this postmarket data may result in changes to the labeling or device approval. The FDA may withdraw PMA approval of a device if there is doubt that the device is safe or effective, or they may take action if the required conditions of approval have not been met.

Read the full draft guidance.