8/9/2019 FDA's Notice for a Workshop on How to Oversee Software Used in Medical Devices

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36886 Federal Register / Vo l. 61, No. 136 / Monday , Ju ly 15 , 1996 / Not ices

Policy and Research, Executive Office Center,2101 East Jefferson Street, Su ite 601,Rockville, Maryland. 20852, (301) 5941445.

Dated: July 8, 1996.

Clifton R. Ga us,

Administrator.

[FR Doc. 9617879 Filed 71296; 8:45 am ]

BILLING CODE 416090M

Food and Drug Administration

[Docket No. 90F0063]

Henkel Corp.; Withdrawal of FoodAdditive Petition

AGENCY: Food and Drug Administration,HHS.

ACTION: Notice.

SUMMARY: The Food and DrugAdmin istration (FDA) is announ cing thewithd rawal, without prejudice to future

filing, of a food add itive petition (FAP0B4194) prop osing that th e foodadditive regulations be amend ed toprovide for the safe use of a mixed esterprodu ct resulting from the reaction ofpentaerythritol and dipen taerythritolwith C14-C22 fatty acids as a releaseagent for ethylene-1,4-cyclohexylenedimethylene tereph thalate copolymers,polyethylene phth alate polymers, andpoly(tetramethylene terephthalate)intended to contact food.

FOR FURTHER INFORMATION CONTACT:Mitchell A. Cheeseman , Center for FoodSafety and Applied Nu trition (HFS

217), Food and Drug Admin istration,200 C St. SW., Washin gton, DC 20204,2024183083.

SUPPLEMENTARY INFORMATION: In a noticepublished in the Federa l Register ofMarch 15, 1990 (55 FR 9772), FDAannou nced that a food additive petition(0B4194) had been filed by Hen kelCorp., Organic Prod ucts Division, 300Brookside Ave., Ambler, PA 19002,(Currently c/o Bruce A. Schwemmer,Bruce EnviroExcel Group, Inc., 94Buttermilk Bridge Rd., Washington, NJ07882). The p etition p roposed to amen dthe food add itive regulations in 178.3860Release agents (21 CFR178.3860) to provid e for the safe use ofa mixed ester prod uct resulting from th ereaction of pentaerythritol anddipen taerythritol with C14-C22 fattyacids as a release agent for ethylen e-1,4-cyclohexylene dimeth yleneterephthalate copolymers, polyethylenephth alate polymers, andpoly(tetramethylene terephthalate)intended to contact food. Henkel Corp.has now w ithdrawn the petition w ithoutprejud ice to a futur e filing (21 CFR171.7).

Dated: Jun e 25, 1996.

Alan M. Rulis,

Director, Office of Premarket Ap proval,Center for Food Safety and A pp lied Nutrition.

[FR Doc. 9617826 Filed 71296; 8:45 am]

BILLING CODE 416001F

[Docket No. 86D0380]

Medical Devices; Medical SoftwareDevices; Notice of Public Workshop

AGENCY: Food and Drug Administration,HHS.

ACTION: Notice of public w orkshop.

SUMMARY: The Food and DrugAdmin istration (FDA) and the NationalLibrary of Medicin e (NLM) areannou ncing a public workshop todiscuss d efinitions of med ical softwaredevices, criteria for defining riskcategories, software quality audits andpremarket n otification, comm ercial

distribution of software, and the optionsavailable for regulating medical softwaredevices. FDA has noted som e confusionamong man ufacturers regarding whichrequirements app ly to medical softwaredevices and accessories. This workshopwill help to clarify the requirements,and provide FDA with information tobetter assess the risks to p ublic healthassociated w ith d ifferent types ofmedical software d evices.

DATES: The workshop w ill be held onSeptember 3 and 4, 1996, from 9:30 a.m.to 4:30 p.m. Participants and otherpersons wh o want to present data or

information must be p resent by 9 a.m.Written notices of participation m ust besubmitted on or before August 5, 1996.

ADDRESSES: The workshop w ill be heldat the National Institutes of Health,Natcher Conferenc e Center, 45 CenterDr., Bethesd a, MD 20892. Writtencommen ts, identified with the d ocketnu mber found in brackets in theheading of this documen t, regarding thesubjects being discussed at th eworkshop m ay be submitted to theDockets Management Branch (HFA305), Food and Drug Adm inistration,12420 Parklawn Dr., rm. 123,Rockville, MD 20857. A more detailedlisting of the w orkshop topics, issues,background information, as well asregistration forms, can be obtained afterAugust 1, 1996, through th e Center forDevices and Radiological Health (CDRH)Facts-On-Demand system. To receivethe public workshop on medicalsoftware devices docum ents to yourFAX machin e, call the CDRH Facts-On-Demand system at 8008990381 or3018270111 from a touch-tonetelephone. At the first voice promp tpress 1 to access DSMA Facts, at second

voice promp t press 2, and then enter thedocum ent nu mber, 1072, followed bythe pound sign (#). Then follow th eremaining voice prompts to comp leteyour request. The information will besent by FAX. All workshop-relatedinformation can also be obtained byusin g the World Wide Web. FDAs hom epage address may be accessed at h ttp:/

/www.fda.gov.FOR FURTHER INFORMATION CONTACT:Charles S. Furfin e, Center for Devicesand Radiological Health (HFZ143),12720 Twin brook Pkwy., Rockville, MD20852, 3014432536, ext. 16; FAX3014439101; or EMailcsf@fdad r.cd rh .fda.gov.

Registration forms sh ould be sent toCharles Furfine (address above). Thereis no registration fee but advanceregistration is required. Interestedpersons are encouraged to register earlybecause space is limited. If you h ave adisability that affects your attendance at,or participation in, this m eeting, pleasecontact Charles S. Furfine (addressabove) in w riting and iden tify yourneeds. The availability of appropriateaccommodations cannot be assuredunless p rior written notification isprovided.SUPPLEMENTAL INFORMATION:

I. Backgroun d

On Sep tember 25, 1987 (52 FR 36104),FDA published a notice of availability ofa Draft Policy Guidan ce for Regulationof Compu ter Produ cts, which theagency was m aking available forcomment. The guidan ce was intended to

provide software developers andmanu facturers of medical devices withguidance about which software productswere regulated as medical devices andwhich might be exempt from particularregulatory controls, such as premarketnotification. A 1989 d raft of the FDAsoftware policy reiterated the basicstatements of the 1987 draft, but alsoaddressed specific issues related toblood-bank software produ cts. The 1989draft also addressed the issue of whichmedical software devices should beexempt from general controls, includingthe current good man ufacturing practice

regulations. The agency stated in the1989 draft that med ical software devices(unclassified medical software d evicesthat are not compon ents, parts, oraccessories to classified devices) wouldnot be su bject to active regulatoryoversight if they are inten ded toinvolve competent hu man interventionbefore any impact on hum an healthoccurs (e.g., where clinical judgmentand experience can be used to checkand interpret a systems output) * * *.

Since 1989, FDA has gainedexperience in app lying the criterion of

8/9/2019 FDA's Notice for a Workshop on How to Oversee Software Used in Medical Devices

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36887Federal Register / Vo l. 61, No. 136 / Monday , Ju ly 15 , 1996 / Not ices

competent human intervention on acase-by-case basis to med ical softwaredevices and has noted two problemsthat arise. First, some man ufacturershave brought to market medicalsoftware d evices that are actuallyaccessories to classified medical deviceswithout a premarket submission, mostlikely because of confusion over w hich

devices were meant to be covered by thedraft policy. Comp onents, parts, oraccessories to classified devices areregulated according to the class of theparent device and are n ot covered by thedraft policy. Second, the increasingcomplexity and soph istication ofcurrent software devices makes itincreasingly difficult to d ecide wh enhealthcare practitioners can, in fact,comprehen d the functions performed bythe software sufficiently to know wh ensignificant errors have occurred.

FDA is, therefore, reassessing itsposition regarding the regulation of

medical software devices. Further, it isimportant that any exemp tion fromregulatory oversight continue to bebased upon an assessment of the risk tohum an health, as provided by law.Additionally, FDA believes thatincreased app lication of properengineering practices provides anopportun ity to develop preproductioncontrols for the majority of medicalsoftware devices wh ich m ay obviate theneed for premarket subm issions for suchmedical software devices in some cases.

II. Purpose and Tentative Agenda of theWorkshop

The pu rpose of the workshop is toobtain information on su bjects such as:(1) Definitions th at could be u sed in theclassification of medical softwaredevices; (2) criteria that could be usedto define r isk categories; (3) the scopeand con tent of a proposed softwarequality audit that might be used in lieuof premarket notification for certainmed ical software devices; (4) factorsrelated to the u nique ch aracteristics ofthe d istribution of software that theagency could consider in determinin gwheth er a particular medical softwareprodu ct is intended by the manu facturer

or sponsor for commercial d istribution;and (5) potential scenarios andregulatory hurd les to implemen ting arisk-based classification process. Thiswill provide FDA with in formation tobetter assess the risks to p ublic healthassociated w ith d ifferent types ofmedical software d evices.

Presiding over the workshop will be:Harvey Rudolph, Acting DeputyDirector, Office of Science an dTechn ology, Center for Devices andRadiological Health, and HaroldSchoolman, Deputy Director for

Education and Research, NLM. Theywill be assisted by other FDA and NLM

officials.

Opening remarks will be made by

representatives of the sp onsoringinstitutions, FDA and NLM, identifying

the respective agencys interests in

medical software d evices. Following

these presentations, FDA will make apresentation outlinin g its

responsibilities for regulating medicalsoftware d evices and for iden tifying

specific areas where information from

the pu blic could be most useful.Followin g FDAs presen tation, a specific

period of time will be provided for other

participants to make presentations.There w ill be break-out sessions

following these presentations wh erediscussion can take place on specific

topics, such as those noted above.

Interested persons wh o wish to

present prepared comm ents at the

plenary session to the public workshopmay, on or before August 5, 1996,

submit to the Dockets Management

Branch (address above) a written n oticeof participation iden tified with the

docket number found in brackets in the

heading of this documen t, includingname, address, telephone number,

business affiliation, and a briefsumm ary of the presentation. The

limited time available will allow 10

minu tes or less for each presentation.

FDA requests that ind ividuals or

groups having similar interests

consolidate their commen ts and presentthem through a single representative.

FDA may require joint presentations bypersons with comm on interests. A

schedu le of the allotted times will beavailable at the workshop. Eachparticipant w ill be notified before theworkshop of the app roximate time of hisor her presentation. The schedule w illbe placed on file in the DocketsManagement Branch (address above)under the docket num ber found inbrackets in the head ing of thisdocum ent. The workshop will alsoinclude an opportun ity for interested

persons wh o did not submit a notice ofparticipation to make brief statements orcommen ts, if time permits.

The workshop is informal; however,no participant may interrupt thepresentation of another participant.

Dated: July 9, 1996.

William K. Hubbard ,

Associate Comm issioner for Policy

Coordination.

[FR Doc. 9617880 Filed 71296; 8:45 am]

BILLING CODE 416001F

[Docket No. 96M0221]

Alcon Laboratories, Inc.; PremarketApproval of Acrysof Models MA60BMand MA30BA Ultraviolet-AbsorbingSoft Acrylic Posterior ChamberIntraocular Lenses

AGENCY: Food and Drug Admin istration,HHS.ACTION: Notice.

SUMMARY: The Food and DrugAdmin istration (FDA) is annou ncing itsapproval of the app lication by AlconLaboratories, Inc., Fort Worth , TX, forpremarket approval, under the FederalFood, Drug, and Cosmetic Act (the act),of Acrysof Models MA60BM andMA30BA ultraviolet-absorbing softacrylic posterior cham ber intraocularlenses. After reviewing therecommend ation of the OphthalmicDevices Panel, FDAs Center for Devicesand Radiological Health (CDRH)

notified th e app licant, by letter ofDecember 22, 1994, of the app roval ofthe application.

DATES: Petitions for admin istrativereview by August 14, 1996.

ADDRESSES: Written requests for copiesof the summ ary of safety andeffectiveness data and petitions foradministrative review to the DocketsManagemen t Branch (HFA305), Foodand Drug Adm inistration, 12420Parklawn Dr., rm. 123, Rockville, MD20857.

FOR FURTHER INFORMATION CONTACT:Donna L. Rogers, Center for Devices an d

Radiological Health (HFZ460), Foodand Drug Adm inistration, 9200Corporate Blvd., Rockville, MD 20850,3015942053.

SUPPLEMENTARY INFORMATION: On May28, 1993, Alcon Laboratories, Inc., FortWorth, TX 761342099, submitted toCDRH an application for premarketapproval of Acrysof Models MA60BMand MA30BA ultraviolet-absorbing softacrylic posterior cham ber intraocularlenses. The d evices are posteriorchamber intraocular lenses and areindicated for replacement of the hu manlens to achieve visual correction of

aphakia in patients 60 years of age andolder when extracapsular cataractextraction or phacoemu lsification areperformed. These lenses are intendedfor placement in the capsu lar bag.

On May 20, 1994, the Oph thalmicDevices Panel of the Med ical DevicesAdvisory Committee, an FDA advisorycommittee, reviewed and recommen dedapproval of the app lication. OnDecember 22, 1994, CDRH app roved th eapplication by a letter to the applicantfrom th e Director of the Office of DeviceEvaluation, CDRH.