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

Freedom of Information Act Requester Scored Win at Federal Appeals Court

The U.S. Court of Appeals for the D.C. Circuit issued a major ruling last week preserving the rights of Freedom of Information Act (FOIA) requesters to proceed to court quickly when agencies don't comply with the legally required timelines to respond to demands for government records.

The court held that FOIA requires agencies to review responsive documents and to tell requesters what documents the agency will produce, what it will withhold, and why, within 20 days of receiving the request (in some cases, 30 days).  Otherwise the agency risks incurring a challenge in federal district court.

In 2011, a lower court ruled that an agency's acknowledgement of a request was enough to trigger the legal requirement that a requester pursue an administrative appeal with the agency before going to court.  However, the three-judge panel of the U.S. Court of Appeals for the D.C. Circuit unanimously rejected that stance.
 
By allowing requesters to sue when the time limit is up, the D.C. Circuit decision will likely accelerate some responses in some cases and make it more difficult for agencies to selectively delay requests.

FDA Regulates Keyword Searches on the Internet

The U.S. Food and Drug Administration recently sent a Warning Letter to M.D.R. Fitness Corp., a Florida-based researcher and manufacturer of nutritional supplements.  In the letter, the FDA alleges a number of problems, but the one that's catching attention concerns the company's website search engine.

According to the FDA, typing the keyword "cancer" or "diabetes" into the product search field located on the company's website brings up several products.  Because those products are associated with disease terms, the FDA said, the company is thus “implying that its products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases,” which make them unapproved new drugs.

In a previous case, the FDA used metadata as evidence of intended use involving another company's dietary supplement.  Metadata are similar to keyword association in that both are largely invisible to the public.  These recent cases indicate that the FDA is targeting word associations on product websites. 

FDA Warns Cosmetic Companies to Tone Down Anti-Aging Claims

After years of looking the other way, the FDA is going after cosmetic companies for how they market their products.  In the past two months, the agency sent warning letters to at least six companies, including Avon and Lancôme, for making drug-like anti-aging claims about their products.  As a comparison, according to the FDA's public database, the agency only issued between one to three warning letters per year between 2004 and 2011 (none between 2006 and 2010) regarding similar claims.

Claims made for these products to which the FDA objected include:

• The at-home answer to wrinkle-filling injections. Start rebuilding collagen in just 48 hours.
• Rebuild collagen to help plump out lines and wrinkles.
• Stimulate elastin to help improve elasticity and resilience.
• Regenerate hydroproteins to help visibly minimize creasing.
• helps reactivate skin’s repair process to recreate fresh skin & help dramatically reverse visible wrinkles.
• help boost production of collagen and elastin.
• See significant deep wrinkle reduction in UV damaged skin, clinically proven.
• Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques . . . helps recreate a younger, lifted look in the delicate eye area.

Under the federal Food Drug & Cosmetic Act, a product intended to diagnose, mitigate, treat, or prevent disease, or to affect the structure or function of the body is classified as a drug.  If such a product is not generally recognized by qualified experts as safe and effective when used as labeled, it is a “new drug” and requires an approved New Drug Application to be marketed legally in the U.S.

The FDA gave these companies 15 days to respond to the warning letters.  If you have any questions about the warning letters or any claims about your cosmetic products, please contact the firm.

Avon Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323738.htm

Lancôme Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm318809.htm

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.