FDA Releases Draft Guidances on Wellness Medical Devices and Accessories

The FDA issued two draft guidances on January 20 outlining its approach to regulating low-risk devices intended to promote general wellness as well as medical device accessories.

In the draft guidance General Wellness: Policy for Low Risk Devices, the FDA states that it will not regulate a general wellness product.  However, such a product becomes a medical device subject to FDA regulation when it refers to its use for a specific disease or condition and that application is invasive or goes beyond the general goals of most wearables (e.g., help people monitor their exercise, food consumption and heart rate).

Specifically, devices that claim any of the following are NOT general wellness devices according to the draft guidance:

treat or diagnose obesity;

treat eating disorders, such as anorexia;

help treat anxiety;

diagnose or treat autism;

treat muscle atrophy or erectile dysfunction;

restore a structure or function impaired due to a disease.

In the draft guidance Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types, the FDA states that it will regulate medical device accessories based on the risks they present when used with their parent devices, and not automatically based on the risks of their parent devices.  

The public has 90 days to submit comments regarding the two draft guidances.

FDA Issues Draft Guidance Regarding MDDS

The FDA has released draft guidance last Friday, stating that the agency considers medical device data systems (MDDS) to be safe and effective, and does not intend to regulate them.

According to the guidance, the FDA will not mandate compliance to controls related to MDDS, including registration, premarket review and postmarket reporting, if they do not aim to control or alter the function of any connected medical devices, but rather are intended to:

• Facilitate electronic transfer or exchange of medical device data;
• Store and retrieve medical device information, such as blood pressure data;
• Convert medical device data from one format to another; and
• Display medical device information.

Comments for the draft guidance will be accepted through August 19th.

FDA Issued Final Guidance on Mobile Apps

Today the FDA released a final guidance document outlining the agency's approach to mobile apps.  According to the guidance document, the FDA intends to exercise enforcement discretion for the majority of mobile apps that pose minimal risk to consumer (meaning the FDA will not regulate these apps as medical devices).  These include mobile apps that:

• 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 (PHR) or Electronic Health Record (EHR) systems.

Instead, the FDA intends to focus its oversight on mobile medical apps that:

• are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
• ransform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.

For more information: Mobile Medical Applications Final Guidance: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

FDA to exempt certain devices from 510(k) process

The FDA released a guidance that will relax the agency's requirements for 510(k) clearance for some medical devices.

The FDA has identified certain class I and class II in vitro diagnostic and radiology devices that have established safety and effectiveness profiles and for which it intends to exempt from the 510(k) process.

While the FDA proposes and finalizes regulations for the down classification and exemption changes, the agency said it intends to exercise enforcement discretion with regard to 510(k) submission requirements for these devices.

FDA to Exempt Certain Diagnostic (IVD) and Radiology Devices from 510(k) Requirements

The FDA has issued a draft guidance that would exempt 30 different device typess from 510(k) clearance requirements. These devices include common urine and blood tests, alcohol breath tests, blood clotting protein tests and radiology device accessories.

According to the draft guidance, the in vitro diagnostic (IVD) and radiology devices have well-established safety and effectiveness profiles, so the FDA plans to use its enforcement discretion to exempt the device from premarket notification requirements as long as those devices “do not exceed the limitations on exemption specified in the device classification regulations.” In the future, the FDA also intends to reduce the pre-market regulatory burden on additional IVDs and radiology device types.

The FDA said it intends to continue to enforce all other applicable requirements for the devices, including, but not limited to, registration and listing and current good manufacturing practice regulations as set forth in the quality system regulations.

FDA to Revise Device Rules, but Most are Minor for Now

In a press release today, the FDA announced that it will be making 25 changes this year to its 510(k) medical device clearance program, but will hold off on any major moves until after the release of an Institute of Medicine (IOM) report scheduled for this summer.

The agency's Center for Devices and Radiological Health said it would implement changes including the streamlining of the "de novo" review process for lower-risk devices, more clarity on when medical device manufacturers must submit clinical data in a 510(k) submission, and the creation of a council to improve regulatory science.

Most of the controversial changes to the 510(k) program proposed by the agency last year were temporarily taken off the table until the release of the IOM review slated for this summer.  They include the ability to revoke 510(K) clearances, increased post-market surveillance, and the establishment of a new classification (IIb) for medical devices that would require the submission of clinical evidence.

The agency maintains that the changes (PDF) will be a boon for the process by which the vast majority of medical devices are cleared for the U.S. market, delivering "a smarter medical device program that supports innovation, keeps jobs here at home and brings important, safe and effective technologies to patients quickly," according to a statement by Shuren.

In order to facilitate innovation in medical devices, Shuren said the FDA will:

• Streamline the review process for innovative, lower-risk products, called the "de novo" process by Sept. 30.
• Publish guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency on July 31.
• Develop a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies by Sept. 15.
• Establish a new Center Science Council of senior FDA experts within the agency’s medical device center to assure more timely and consistent science-based decision making. FDA will publish the charter for the council its website on March 31. The agency plans to publish initial results of a 510(k) audit by the council on June 15.

To bolster the safety of medical devices, Shuren said the FDA will:

• Establish a public database of important device information, such as medical device photographs, labeling and summaries of the basis for the FDA’s decision to clear specific devices. The database will be discussed at a public meeting taking place April 7 and 8.
• Require a brief description of scientific information regarding the safety and effectiveness known to the manufacturer for select higher-risk devices on a case-by-case basis through device-specific guidance.

Knee device should not have been cleared, says FDA

In a press release released by the FDA today, the agency announced that an orthopedic device used in the knee should not have been cleared for marketing in the United States.

According to the FDA, a scientific re-evaluation of the device was conducted because records from the original review was not adequate to "dispel questions about the role of outside pressures on the review process."

The timing of this press release is interesting because the FDA is currently re-evaluating its medical device clearance process to see if it needs to be improved to ensure the safety and effectiveness of medical devices marketed in the U.S.  Proponents of the change have argued that the current review process is not transparent enough and is susceptible to outside influences.  The finding by the FDA about the orthopedic device appears to support that assertion.