FDA Issues Draft Guidance on Mobile Medical Apps Does the App Present a Risk to Patients if it Does Not Function as Intended?

Transcription

1 July 25, 2011 FDA Issues Draft Guidance n Mbile Medical Apps Des the App Present a Risk t Patients if it Des Nt Functin as Intended? Fr mre infrmatin, cntact: Ed Basile ebasile@kslaw.cm Laurie Clarke lclarke@kslaw.cm Marian Lee mlee@kslaw.cm Beverly Lrell, MD blrell@kslaw.cm Jessica Ringel jringel@kslaw.cm King & Spalding Washingtn, D.C Pennsylvania Avenue, NW Washingtn, D.C Tel: Fax: On July 19, 2011, the U.S. Fd and Drug Administratin (FDA r the Agency) released a Draft Guidance fr Industry and Fd and Drug Administratin Staff n Mbile Medical Applicatins. The draft annunces FDA s intentin t regulate mbile applicatins (apps) that either have traditinally been cnsidered medical devices r affect the perfrmance r functinality f a currently regulated medical device. Accrding t Jeffrey Shuren, MD, directr f FDA s Center fr Devices and Radilgical Health (CDRH), [FDA s] draft apprach calls fr versight f nly thse mbile medical apps that present the greatest risk t patients when they dn t wrk as intended. 1 Althugh FDA acknwledged that this prpsed apprach des nt cver the majrity f medical apps, 2 its scpe is brad. Public cmments n the draft Guidance may be submitted nline r in writing thrugh Octber 19, I. The Scpe f the Draft Guidance The draft Guidance defines three key terms: Mbile platfrms are cmmercial ff-the-shelf (COTS) cmputing platfrms, with r withut wireless cnnectivity, that are handheld in nature. Examples include smartphnes, tablet cmputers, and persnal digital assistants (PDAs). A mbile applicatin r mbile app is a sftware applicatin that can be executed (run) n a mbile platfrm, r a web-based sftware applicatin that is tailred t a mbile platfrm but is executed n a server. A mbile medical applicatin r mbile medical app meets the definitin f a device under sectin 201(h) f the Federal Fd, Drug, and Csmetic Act (FD&C Act), 4 and either (a) is used as an accessry t a regulated medical device ; r (b) transfrms a mbile platfrm int a regulated medical device. Mbile medical applicatins are a subset f mbile applicatins. 1 f 5

2 A. Mbile Medical Apps FDA currently intends t regulate mbile medical applicatins. FDA will determine whether a prduct is a mbile medical app based n its intended use. The draft Guidance identifies uses/functins f bth categries f mbile medical apps and prvides examples f them: Mbile apps that act as accessries t regulated medical devices: Mbile apps that cntrl the intended use, functin, mdes, r energy surce f the cnnected medical device will be cnsidered mbile medical apps. Examples include apps that prvide the remte display f data frm bedside mnitrs, the display f medical images frm a Picture Archiving and Cmmunicatins System (PACS), r transmit cntrl signals t insulin pumps frm a mbile platfrm. Mbile apps that create alarms, recmmendatins, r new data by analyzing r interpreting medical device data will als be cnsidered mbile medical apps. 5 Examples include sftware that analyzes bld glucse readings t help manage diabetes and apps that activate an alarm based n changes in recrded arterial xygen saturatin levels and pulse rate. Mbile apps that transfrm a mbile platfrm int a medical device: Mbile apps can transfrm mbile platfrms int medical devices by using attachments, display screens, r sensrs. Examples include mbile apps that attach a bld glucse strip reader t a mbile platfrm t functin as a glucse meter r use a built-in meter n a mbile platfrm t cllect mtin infrmatin n sleep apnea. Mbile apps that allw the user t input patient-specific infrmatin can als transfrm a mbile platfrm int a medical device by using frmulas r prcessing algrithms t generate a patient-specific result, diagnsis, r treatment recmmendatin that is targeted at either healthcare prviders, cnsumers, r bth. Examples include mbile apps that cllect patient-specific respnses t a questinnaire and cmpute a prgnsis fr a particular disease r cnditin, r calculate dsages fr a specific medicatin r treatment. Appendix A f the draft Guidance prvides additinal examples f mbile medical apps. B. Prducts Excluded frm Mbile Medical App Regulatin In the Guidance dcument, FDA identifies the fllwing categries f mbile apps that it des nt cnsider t be mbile medical apps: Electrnic textbks r references. FDA excludes [m]bile apps that are electrnic cpies f medical textbks, references, r teaching aids, r are slely used t prvide clinicians with training.... These apps 2 f 5

3 d nt cntain patient-specific infrmatin, but culd prvide examples f a specific medical specialty r cnditin. General health and wellness mbile apps. FDA als excludes [m]bile apps that are slely used t lg, recrd, track, evaluate, r make decisins r suggestins related t develping r maintaining general health and wellness and that are nt intended fr curing, treating, diagnsing, r mitigating a specific disease, disrder, patient state, r any specific, identifiable cnditin. Examples include diet lgs, dietary suggestins based n a calrie cunter, exercise suggestins, and appintment reminders. Office administratin mbile apps. FDA excludes [m]bile apps that nly autmate general ffice peratins, [such as] billing, inventry, appintments, r insurance transactins. Examples include apps that replace paper-based entry f patient histries and apps that determine insurance billing cdes. Generic aids. FDA further excludes [m]bile apps that are generic aids that assist users but are nt cmmercially marketed fr a medical use. Examples include a general magnifying glass app r a nte-taking app. Electrnic r persnal health recrds. Finally, FDA excludes frm the definitin f mbile medical apps any mbile apps that functin nly as electrnic health recrds r persnal health recrds. FDA ntes that the majrity f these mbile apps autmate cmmn medical knwledge r allw individuals t selfmanage their disease r cnditin. 6 FDA des nt regulate these types f mbile apps. Hwever, the Agency plans t mnitr them t determine whether additinal actins are necessary t prtect the public health. C. Regulated Entities FDA states in the draft Guidance that mbile medical app manufacturers are respnsible fr their mbile medical apps cmpliance with FDA regulatins. A mbile medical app manufacturer is any persn r entity that manufactures mbile medical apps in accrdance with 21 C.F.R. Parts 803, 806, and 807. This definitin includes any persn r entity that initiates specificatins, designs, labels, r creates, a sftware system r applicatin in whle r frm multiple sftware cmpnents. FDA cnsiders the fllwing t be examples f mbile medical device manufacturing activities: Creating, designing, labeling, remanufacturing, r mdifying sftware systems, including ff-the-shelf sftware, frm multiple cmpnents t perfrm as a mbile medical app. Prviding mbile medical app functinality thrugh a web service fr use n a mbile platfrm. Initiating specificatins fr mbile medical apps that are develped r manufactured by third parties, e.g., cntract manufacturers, fr cmmercial distributin. Creating a mbile medical app fr use n a mbile platfrm, r creating a mbile app t be supprted by hardware attachments t a mbile platfrm that has a device intended use. 3 f 5

4 An individual r entity perfrming any f these functins is a mbile app manufacturer subject t FDA device regulatry requirements. On the ther hand, FDA excludes frm the definitin f mbile medical app manufacturers entities that exclusively distribute mbile medical apps, withut engaging in manufacturing functins, e.g., Andrid Market, itunes Stre, and BlackBerry App Wrld. FDA als excludes mbile platfrm manufacturers, e.g., smartphne manufacturers, that slely distribute[] r market[ their] platfrm[s] with n device intended use. Mbile platfrm manufacturers are cnsidered cmpnent manufacturers (21 C.F.R (c)) and are exempt frm quality systems, registratin, and listing requirements. Therefre, if an entity manufactures a smartphne which is able t run ther entities mbile medical apps, but des nt market the phne fr medical use, the phne manufacturer is nt a mbile medical app manufacturer. II. Regulatry Apprach Fr mbile medical apps that are subject t FDA regulatin, manufacturers shuld satisfy the criteria assciated with the applicable device classificatin. If the mbile medical app, n its wn, falls under a device classificatin, then the manufacturer is subject t thse classificatin requirements. Accessries t medical devices generally have the same regulatry classificatin and are subject t the same requirements as their parent devices. Hwever, FDA acknwledges that this apprach may nt be well-suited fr mbile medical apps that serve as an accessry t anther medical device because f the wide variety f functins mbile medical apps can ptentially perfrm. Thus, the Agency is seeking cmment n hw it shuld regulate mbile medical apps that are accessries s that the apps safety and effectiveness can be reasnably assured. FDA states that mbile medical apps that add medical device functins t mbile platfrms are subject t the classificatin requirements applicable t the added medical device functins. FDA ntes that sme mbile medical apps meet the definitin f a Medical Device Data System (MDDS). 7 MDDSs are cmputer- r sftware-based devices that passively and electrnically transfer, stre, display r cnvert medical device data; these devices d nt generate r analyze data. Mbile medical apps that meet the definitin f MDDS wuld be regulated as MDDSs, i.e., they wuld be Class I devices that are exempt frm 510(k) requirements. FDA indicates that mbile medical app manufacturers are subject t the same regulatry requirements as ther medical device manufactures. Applicable requirements include: device establishment registratin and listing; investigatinal device exemptins (IDEs); labeling; premarket clearance r apprval; Quality Systems Regulatin (QSR), unless the device is 510(k) exempt; adverse event reprting; and crrectins and remvals. FDA expects distributrs f mbile medical apps t cperate with manufacturers in cnducting crrectins and remvals. FDA recmmends that manufacturers f all mbile apps that may meet the definitin f a device cmply with the Quality Systems Regulatin (21 C.F.R. Part 820) regarding design and develpment, even if the mbile app is nt a mbile medical app. FDA pints ut that the majrity f sftware-related device failures are due t design errrs, e.g., failure t validate sftware prir t rutine maintenance. The draft Guidance des nt address several related issues, such as wireless safety, classificatin and submissin requirements fr clinical decisin supprt sftware, r the applicatin f quality systems t sftware. FDA intends t address these issues in separate guidance dcuments. 4 f 5

5 * * * * King & Spalding will cntinue t mnitr develpments in FDA s regulatin f mbile and sftware-based technlgy, including mbile medical apps. Please cntact us if we can assist yu in evaluating whether yur prducts are mbile medical apps r in cmplying with FDA s requirements. Celebrating mre than 125 years f service, King & Spalding is an internatinal law firm that represents a brad array f clients, including half f the Frtune Glbal 100, with 800 lawyers in 17 ffices in the United States, Eurpe, the Middle East and Asia. The firm has handled matters in ver 160 cuntries n six cntinents and is cnsistently recgnized fr the results it btains, uncmprmising cmmitment t quality and dedicatin t understanding the business and culture f its clients. Mre infrmatin is available at This alert prvides a general summary f recent legal develpments. It is nt intended t be and shuld nt be relied upn as legal advice. 1 FDA News Release, FDA utlines versight f mbile medical applicatins (July 19, 2011), at 2 Bakul Patel, Plicy Advisr t FDA s Center fr Devices and Radilgical Health (CDRH ), quted in Sandra Yin, FDA Prpses Guidance fr Certain Mbile Medical Apps, Medscape Tday News (July 20, 2011). 3 Submit written cmments t the Divisin f Dckets Management (HFA-305), Fd and Drug Administratin, 5630 Fishers Lane, rm. 1061, Rckville, MD Submit electrnic cmments t Identify all cmments with Dcket N. FDA-2011-D Sectin 201(h) f the FD&C Act defines medical device t mean: an instrument, apparatus, implement, machine, cntrivance, implant, in vitr reagent, r ther similar r related article, including any cmpnent, part, r accessry, which is-- (1) recgnized in the fficial Natinal Frmulary, r the United States Pharmacpeia, r any supplement t them, (2) intended fr use in the diagnsis f disease r ther cnditins, r in the cure, mitigatin, treatment, r preventin f disease, in man r ther animals, r (3) intended t affect the structure r any functin f the bdy f man r ther animals, and which des nt achieve its primary intended purpses thrugh chemical actin within r n the bdy f man r ther animals and which is nt dependent upn being metablized fr the achievement f its primary intended purpses. 5 In a future guidance, FDA will address mbile medical apps that analyze r prcess medical device data frm mre than ne medical device. FDA ntes that requiring these apps t cmply with the same requirements as their cnnected devices may nt be apprpriate in all cases. 6 Examples include apps that lg, track, and graph manually-entered (keyed in) data that lead t reminders r alarms; act as data viewers fr patient educatin; rganize, stre, and display persnal health data...; r allw fr general dse ver the cunter (OTC) lkups and use drug labeling Fr mre infrmatin n MDDSs, see ur client alert FDA Issues Rule t Regulate Medical Device Data Systems (Feb. 24, 2011), at 5 f 5