The FDA warns consumers not to use unapproved apps and devices to diagnose concussion

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FDA warns pub­lic not to use unap­proved or uncleared med­ical devices to help assess or diag­nose a con­cus­sion (news release):

Today, the U.S. Food and Drug Admin­is­tra­tion is warn­ing the pub­lic not to use med­ical devices mar­ket­ed to con­sumers that claim to help assess, diag­nose or man­age head injury, includ­ing con­cus­sion, trau­mat­ic brain injury (TBI) or mild TBI. In a new safe­ty com­mu­ni­ca­tion, the FDA warned that such tools — such as apps on a smart­phone mar­ket­ed to coach­es or par­ents for use dur­ing sport­ing events — have not been reviewed by the FDA for safe­ty and effi­ca­cy and could result in an incor­rect diag­no­sis, poten­tial­ly lead­ing to a per­son with a seri­ous head injury return­ing to their nor­mal activ­i­ties instead of get­ting med­ical care.

To date, there are a lim­it­ed num­ber of med­ical devices that have been cleared or approved by the FDA to aid in the diag­no­sis, treat­ment, or man­age­ment of con­cus­sion, and all of them require an eval­u­a­tion by a health care professional.

“I want to be clear, there are cur­rent­ly no devices to aid in assess­ing con­cus­sion that should be used by con­sumers on their own. Using such devices can result in an incor­rect diag­no­sis after a head injury that could lead a per­son with a seri­ous injury to return to their nor­mal activ­i­ties instead of seek­ing crit­i­cal med­ical care, putting them at greater dan­ger,” said Jef­frey Shuren, M.D., J.D., direc­tor of the FDA’s Cen­ter for Devices and Radi­o­log­i­cal Health.

The FDA Safety Communication:

The FDA Rec­om­mends Only Using Cleared or Approved Med­ical Devices to Help Assess or Diag­nose a Head Injury, Includ­ing Concussion

• Pur­pose: The U.S. Food and Drug Admin­is­tra­tion (FDA) is con­cerned that prod­ucts that do not have FDA clear­ance or approval are being mar­ket­ed to indi­vid­u­als, includ­ing par­ents and care­givers, ath­let­ic coach­es, and health care providers for the assess­ment, diag­no­sis, or man­age­ment of a head injury, includ­ing con­cus­sion. The FDA is issu­ing this com­mu­ni­ca­tion to make the pub­lic and health care providers aware of the poten­tial seri­ous risks which may be asso­ci­at­ed with the use of unap­proved or uncleared med­ical devices for the diag­no­sis, treat­ment or man­age­ment of a con­cus­sion. The FDA reminds indi­vid­u­als to seek treat­ment by a health care provider if any head injury, includ­ing con­cus­sion, is suspected.
• Sum­ma­ry of Prob­lem and Scope: The FDA has iden­ti­fied sev­er­al man­u­fac­tur­ers that were mar­ket­ing med­ical devices for con­cus­sion diag­no­sis, treat­ment, or man­age­ment with­out the FDA’s approval or clear­ance. The use of unap­proved med­ical devices may lead to an incor­rect diag­no­sis. An incor­rect diag­no­sis of “no head injury” after an injury, for exam­ple, could lead a per­son with a seri­ous head injury to return to their nor­mal activ­i­ties instead of get­ting med­ical care. Not get­ting need­ed med­ical care and return­ing to nor­mal activ­i­ties could lead to wors­en­ing of the injury. To date, there are a lim­it­ed num­ber of med­ical devices that have been approved or cleared by the FDA to aid in diag­no­sis, treat­ment, or man­age­ment of head injury, includ­ing sus­pect­ed con­cus­sion and oth­er trau­mat­ic brain injuries. Addi­tion­al­ly, the FDA has not approved or cleared any devices that can assess or diag­nose a head injury, includ­ing sus­pect­ed con­cus­sion and oth­er trau­mat­ic brain injuries with­out an eval­u­a­tion by a health care provider.

News in Context:

• Study: Con­cus­sion diag­noses among chil­dren and teenagers increased by 71% from 2010 through 2015
• The FDA clears two com­put­er­ized cog­ni­tive tests to assist in med­ical eval­u­a­tions fol­low­ing brain injury or concussion
• Pear Ther­a­peu­tics rais­es $50M to devel­op and mar­ket a port­fo­lio of dig­i­tal ther­a­peu­tics for men­tal health