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In the draft guidance General Wellness: Policy for Low Risk Devices, the FDA states that it will not regulate a general wellness product.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Specifically, devices that claim any of the following are NOT general wellness devices according to the draft guidance: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In the draft guidance Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types, the FDA states that it will regulate medical device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FDA Issues Draft Guidance Regarding MDDS

The FDA has released draft guidance last Friday, stating that the agency considers medical device data systems (MDDS) to be safe and effective, and does not intend to regulate them.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Comments for the draft guidance will be accepted through August 19th.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 Finalizes Rule and System to Identify Medical Devices

The Food and Drug Administration (FDA) issued a long-awaited rule today requiring companies to include codes on medical devices that will allow tracking and monitoring of the devices. 

The rule consists of two parts: unique device identifiers (or UDI codes) assigned by device makers to their devices, and a public database (called Global Unique Device Identification Database or GUDID) containing the UDI codes that will be managed by the FDA.

The FDA said medical device records will have to include the UDI code.  The rule also establishes accreditation requirements for agencies that may operate systems for issuing UDI codes.

The FDA plans to phase in the UDI rule.  All Class III devices must carry UDI labels within 1 year.  Most Class II devices must comply within 2 years, and any Class I devices not exempt from the rule will have 5 years to comply. 

The new rule is effective 90 days after today's publication in the Federal Register.

• FDA's News Release on the new rule: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369276.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
• Final rule: https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system
• Draft guidance on GUDID: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

FDA issues guidance for off-label communication

The FDA issued draft guidance this week clarifying conditions under which drug and medical device makers may provide information on off-label uses.  The draft guidance covers unsolicited requests for off-label information.  An unsolicited request is one not initiated in any form by the drug or device maker (or its affiliates) itself.

For a company's response to nonpublic (one-on-one communication) unsolicited requests, the agency has made the following 7 recommendations:

• Response information should be limited to the requestor and treated as private, one-on-one communication.
• Information should be limited to the scope of the initial question.
• Information should be "truthful, non-misleading, accurate, and balanced."
• Information should be scientific in nature.
• Information should be generated "by medical or scientific personnel independent from sales or marketing departments."
• Information should be accompanied by several documents, including a statement notifying the recipient that FDA has not approved the product for the specific off-label use.
• The responding firm should maintain required records, including any follow-up questions from the requester.

For a company responding in public to public (Web sites, discussion boards, and chat rooms that are created and maintained by people other than the manufacturer or its affiliates) unsolicited requests, FDA makes the following 4 recommendations:

• A firm should respond only to a request about its own named product and is not solely about a competitor's product.
• The firm's response "should be limited to providing [its] contact information and should not include any off-label information."
• Those responding on behalf of the firm should clearly disclose their specific involvement with that firm.
• Responses "should not be promotional in nature or tone."

Public comments and suggestions regarding the draft guidance should be submitted within 90 days its publication.

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 proposes regulation of mobile apps

The FDA announced its proposed regulatory approach for mobile medical applications, or apps, designed for smart phones and other handheld devices.

In a draft proposal, the agency defines a small subset of mobile medical apps that affect or may affect the performance or functionality of currently regulated medical devices.  This subset includes mobile medical apps that:

• Are used as an accessory to medical devices already regulated by the FDA (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
• Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices (for example, an application that turns a smartphone into an electrocardiogram machine to detect abnormal heart rhythms or determine whether a patient is experiencing a myocardial infarction). 

 The draft guidance excludes the following from regulation:

• Mobile apps that are electronic "copies" of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received.
• Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.
• Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions.
• Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication.
• Mobile apps that perform the functionality of an electronic health record system or personal health record system.

The agency is seeking input from the public on its draft guidance.  Comments can be submitted for 90 days online or by writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The FDA will update the guidance based on feedback received.

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 Clarifies Malfunction Reporting Requirements For Class I and Low-Risk Class II Devices

The FDA has issued a clarification regarding medical device manufacturers’ and importers’ compliance with malfunction report rules according to the agency’s Medical Device Reporting regulation.

The requirements temporarily cover not only high-risk devices but also Class I and II devices that are not permanently implantable, life-supporting or life-sustaining.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires manufacturers and importers of Class III as well as permanently implantable or life-supporting Class II devices to submit malfunction reports unless granted exemptions by the US Secretary of Health and Human Services or FDA. The FDAAA changed such rules for Class I and low-risk Class II devices, requiring quarterly reporting of malfunctions in summary form, except in instances where the regulator deems a device subject to stricter reporting rules in order to protect public health. In such instances, the FDA will notify those device manufacturers or importers in writing—or post a Federal Register notice—that they would have to provide malfunction reports in a manner that fully complies with the FDA’s Medical Device Reporting rule.

For the time being, however, the FDA will now require all devices to malfunction reporting requirements previously targeting higher-risk devices. The agency plans to more clearly define which devices fall under the less rigorous quarterly malfunction reporting category. In the meantime, the FDA’s clarification states that the agency will subject all devices to more exacting reporting requirements “in order to protect the public health by ensuring that there is no gap in malfunction reporting for any device.”

Interested parties may submit written or electronic comments on the clarification until May 9.

FDA to reclassify Medical Device Data Systems

The FDA has published a final rule to reclassify Medical Device Data Systems (MDDS) from Class III devices requiring premarket approval to Class I devices regulated under much less stringent general controls.

“An MDDS is a device that is intended to transfer, store, convert from one format to another according to preset specification, or display medical device data,” according to the rule. “An MDDS acts only as the mechanism by which medical device data can be transferred, stored, converted or displayed. An MDDS does not modify the data or modify the display of the data. An MDDS by itself does not control the functions or parameters of any other medical device. An MDDS can only control its own functionality. This device is not intended to provide or be used in connection with active patient monitoring. Any product that is intended for a use beyond the use (or functions) identified in this final classification rule is not an MDDS and is not addressed by this rule.”

The final MDDS rule will apply to “all manufacturers,” the FDA says. Critically, this includes hospitals, health care facilities or any other organization that does any of the following:

• Makes any modifications to the MDDS that are outside the parameters of the original manufacturer’s specifications for the device, for purposes of the user’s clinical practice or otherwise for commercial distribution.
• Purchases hardware or software and modifies it to transfer, store, convert or display medical device data for clinical use.
• Develops in-house software with an intended use consistent with an MDDS.
• Develops an in-house system, using multiple components of devices, that has an intended use consistent with an MDDS.

Other key points from the preview to the MDDS final rule include the following:

• The rule does not apply to electronic health record (EHR), personal health record (PHR), computerized physician order entry (CPOE), e-prescribing or word processing systems. Laboratory information systems and picture archiving and communication systems (PACS) are not medical device data systems either.
• An MDDS can covert data to the HTML; PDF; or Health Level Seven International, or HL7, data formats. However, “an MDDS may not otherwise convert, alter, modify or interpret the data that is received from a medical device,” the FDA said.
• Devices that transfer information for the purpose of information exchange, or that can generate or manipulate data on their own, are not considered medical device data systems.
• Such devices as glucose monitors, blood pressure cuffs and active patient monitors are not MDDS. These are Class III devices because they directly support and sustain a patient’s life; as such, they remain subject to stricter regulatory control, as well as to premarket approval.
• Devices intended for use by people who are not health care professionals (data entry clerks, for example) count as MDDS, though the FDA reserves the right, “if, through normal reporting mechanisms or otherwise, FDA determines that the use of these devices by someone other than a health care professional poses an unreasonable risk of illness or injury.”

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.

Latest regulatory trends from RAPS conference

There were several excellent speakers at the RPAS (Regulatory Affairs Professionals Society) annual conference in San Jose last week.  They represented regulatory professionals in the private and public sectors, both domestically and abroad.  Here are some of the take-away messages from the speakers:

• FDA is stepping up enforcement.  This shouldn't come as a surprise if you've been following the agency's enforcement actions lately.  In his speech to the food and dietary supplement industry, FDA's Chief Counsel Ralph S. Tyler stated that the agency has just began its enforcement efforts and that more are yet to come.  Among the areas of concern are the good manufacturing practices (GMP) regulations for dietary supplement products, as well as the notification requirements for new dietary ingredients.  The agency also intends to hold individual more accountable for violations, which would result in more criminal prosecutions of company executives and even employees.
• FTC is stepping up enforcement.  Similarly, the FTC is stepping up enforcement in the area of claim substantiation.  The FTC will be looking at scientific data more closely to determine whether they support claims made about a product.   Companies should pay more attention to testimonials, because according to the government, they are never substantiated. 
• Companies are very interested in the Chinese market, but are frustrated by the regulatory framework there.  Among the conference speakers were five officials from the Chinese State FDA (SFDA), who provided an overview of the medical device approval process in China.  This presentation was one of the popular ones at the conference, and the numbers and types of the questions asked at the end of the presentation showed many companies (large and small) are very interested in the Chinese market, and yet are frustrated with the lack of transparency in the approval process.  Here are some of the policies that can cause frustration:
• According to a SFDA official, if a foreign company manufactures a medical device in China, the company will have to export the finished product out of China.  However, if a Chinese company puts its own label on the same product, it will be able to sell the device in China.  This policy seems to have little to do with safety and efficacy.  
• Also according to the same official, a medical device imported into China will not receive SFDA approval if the device has not received market approval in the country of origin.  The message seemed to be: if this device is not good for your country, it's not good enough for China.
• Questions were asked about whether the SFDA would accept data from clinical trials done outside of the China.  The answer was as clear as water - generally no, but we will decide on a case by case basis, but if we decided you need to do more clinical trials, you need to conduct them in China.  
• Questions were asked about whether the SFDA would meet with companies to discuss their products before the companies submit their applications for approval of their products.  The answer was that the SFDA holds a "open forum" every Thursday during which anyone can participate in a Q&A session with the agency to discuss any regulatory issues.  According to the SFDA official, no appointment is required and people can participate by phone.  So much for confidentiality. 

I am still reviewing my notes and materials from the conference, and plan to blog about other interesting topics I ran across there.

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.