Welcome to Scribd, the world's digital library. Read, publish, and share books and documents. See more
Download
Standard view
Full view
of .
Save to My Library
Look up keyword
Like this
1Activity
0 of .
Results for:
No results containing your search query
P. 1
FDA's Notice for a Workshop on How to Oversee Software Used in Medical Devices

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

Ratings: (0)|Views: 17 |Likes:
Published by huffpostfund
FDA announces that it will hold a public workshop to revisit its software policy. The agency says it is “reassessing its position regarding the regulation of medical software devices” because “increasing complexity and sophistication of current software devices makes it increasingly difficult… to know when significant errors have occurred.”
FDA announces that it will hold a public workshop to revisit its software policy. The agency says it is “reassessing its position regarding the regulation of medical software devices” because “increasing complexity and sophistication of current software devices makes it increasingly difficult… to know when significant errors have occurred.”

More info:

Categories:Types, Research
Published by: huffpostfund on Jun 30, 2010
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as PDF, TXT or read online from Scribd
See more
See less

06/30/2010

pdf

text

original

 
36886
Federal Register
 /Vol. 61, No. 136/Monday, July 15, 1996/Notices
Policy and Research, Executive Office Center,2101 East Jefferson Street, Suite 601,Rockville, Maryland. 20852, (301) 594–1445.Dated: July 8, 1996.
Clifton R. Gaus,
 Administrator.
[FR Doc. 96–17879 Filed 7–12–96; 8:45 am]
BILLING CODE 4160–90–M
Food and Drug Administration
[Docket No. 90F–0063]
Henkel Corp.; Withdrawal of FoodAdditive Petition
AGENCY
:
Food and Drug Administration,HHS.
ACTION
:
Notice.
SUMMARY
:
The Food and DrugAdministration (FDA) is announcing thewithdrawal, without prejudice to futurefiling, of a food additive petition (FAP0B4194) proposing that the foodadditive regulations be amended toprovide for the safe use of a mixed esterproduct resulting from the reaction of pentaerythritol and dipentaerythritolwith C
14
-C
22
fatty acids as a releaseagent for ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers,polyethylene phthalate polymers, andpoly(tetramethylene terephthalate)intended to contact food.
FOR FURTHER INFORMATION CONTACT
:
Mitchell A. Cheeseman, Center for FoodSafety and Applied Nutrition (HFS–217), Food and Drug Administration,200 C St. SW., Washington, DC 20204,202–418–3083.
SUPPLEMENTARY INFORMATION
:
In a noticepublished in the
Federal Register
of March 15, 1990 (55 FR 9772), FDAannounced that a food additive petition(0B4194) had been filed by HenkelCorp., Organic Products Division, 300Brookside Ave., Ambler, PA 19002,(Currently c/o Bruce A. Schwemmer,Bruce EnviroExcel Group, Inc., 94Buttermilk Bridge Rd., Washington, NJ07882). The petition proposed to amendthe food additive regulations in§178.3860
 Release agents
(21 CFR178.3860) to provide for the safe use of a mixed ester product resulting from thereaction of pentaerythritol anddipentaerythritol with C
14
-C
22
fattyacids as a release agent for ethylene-1,4-cyclohexylene dimethyleneterephthalate copolymers, polyethylenephthalate polymers, andpoly(tetramethylene terephthalate)intended to contact food. Henkel Corp.has now withdrawn the petition withoutprejudice to a future filing (21 CFR171.7).
Dated: June 25, 1996.
Alan M. Rulis,
 Director, Office of Premarket Approval,Center for Food Safety and Applied Nutrition.
[FR Doc. 96–17826 Filed 7–12–96; 8:45 am]
BILLING CODE 4160–01–F
[Docket No. 86D–0380]
Medical Devices; Medical SoftwareDevices; Notice of Public Workshop
AGENCY
:
Food and Drug Administration,HHS.
ACTION
:
Notice of public workshop.
SUMMARY
:
The Food and DrugAdministration (FDA) and the NationalLibrary of Medicine (NLM) areannouncing a public workshop todiscuss definitions of medical softwaredevices, criteria for defining risk categories, software quality audits andpremarket notification, commercialdistribution of software, and the optionsavailable for regulating medical softwaredevices. FDA has noted some confusionamong manufacturers regarding whichrequirements apply to medical softwaredevices and accessories. This workshopwill help to clarify the requirements,and provide FDA with information tobetter assess the risks to public healthassociated with different types of medical software devices.
DATES
:
The workshop will be held onSeptember 3 and 4, 1996, from 9:30 a.m.to 4:30 p.m. Participants and otherpersons who want to present data orinformation must be present by 9 a.m.Written notices of participation must besubmitted on or before August 5, 1996.
ADDRESSES
:
The workshop will be heldat the National Institutes of Health,Natcher Conference Center, 45 CenterDr., Bethesda, MD 20892. Writtencomments, identified with the docketnumber found in brackets in theheading of this document, regarding thesubjects being discussed at theworkshop may be submitted to theDockets Management Branch (HFA–305), Food and Drug Administration,12420 Parklawn Dr., rm. 1–23,Rockville, MD 20857. A more detailedlisting of the workshop topics, issues,background information, as well asregistration forms, can be obtained afterAugust 1, 1996, through the Center forDevices and Radiological Health (CDRH)Facts-On-Demand system. To receivethe public workshop on medicalsoftware devices documents to yourFAX machine, call the CDRH Facts-On-Demand system at 800–899–0381 or301–827–0111 from a touch-tonetelephone. At the first voice promptpress 1 to access DSMA Facts, at secondvoice prompt press 2, and then enter thedocument number, 1072, followed bythe pound sign (
#
). Then follow theremaining voice prompts to completeyour request. The information will besent by FAX. All workshop-relatedinformation can also be obtained byusing the World Wide Web. FDA’s homepage address may be accessed at http:/  /www.fda.gov.
FOR FURTHER INFORMATION CONTACT
:
Charles S. Furfine, Center for Devicesand Radiological Health (HFZ–143),12720 Twinbrook Pkwy., Rockville, MD20852, 301–443–2536, ext. 16; FAX301–443–9101; or EMailcsf@fdadr.cdrh.fda.gov.Registration forms should 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 have adisability that affects your attendance at,or participation in, this meeting, pleasecontact Charles S. Furfine (addressabove) in writing and identify yourneeds. The availability of appropriateaccommodations cannot be assuredunless prior written notification isprovided.
SUPPLEMENTAL INFORMATION
:
I. Background
On September 25, 1987 (52 FR 36104),FDA published a notice of availability of a ‘‘Draft Policy Guidance for Regulationof Computer Products,’’ which theagency was making available forcomment. The guidance was intended toprovide software developers andmanufacturers of medical devices withguidance about which software productswere regulated as medical devices andwhich might be exempt from particularregulatory controls, such as premarketnotification. A 1989 draft of the FDAsoftware policy reiterated the basicstatements of the 1987 draft, but alsoaddressed specific issues related toblood-bank software products. The 1989draft also addressed the issue of whichmedical software devices should beexempt from general controls, includingthe current good manufacturing practiceregulations. The agency stated in the1989 draft that medical software devices(unclassified medical software devicesthat are not components, parts, oraccessories to classified devices) wouldnot be subject to active regulatoryoversight if they ‘are intended toinvolve competent human interventionbefore any impact on human healthoccurs (e.g., where clinical judgmentand experience can be used to check and interpret a system’s output) ***.Since 1989, FDA has gainedexperience in applying the criterion of 

You're Reading a Free Preview

Download
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->