Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability, 43689-43690 [2011-18537]

Download as PDF Federal Register / Vol. 76, No. 140 / Thursday, July 21, 2011 / Notices advice to the President concerning the following for people with intellectual disabilities: (A) Expansion of educational opportunities; (B) promotion of homeownership; (C) assurance of workplace integration; (D) improvement of transportation options; (E) expansion of full access to community living; and (F) increasing access to assistive and universally designed technologies. Dated: July 15, 2011. Laverdia Taylor Roach, Director, President’s Committee for People with Intellectual Disabilities. [FR Doc. 2011–18392 Filed 7–20–11; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Mobile Medical Applications.’’ FDA is issuing this draft guidance to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or ‘‘mobile apps’’). At this time, FDA intends to apply its regulatory requirements solely to a subset of mobile apps that the Agency is calling mobile medical applications (mobile medical apps). This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 19, 2011 ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Mobile Medical Applications’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, wreier-aviles on DSKDVH8Z91PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:00 Jul 20, 2011 Jkt 223001 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993– 0002; or to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: For devices regulated by CDRH: Bakul Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993–0002, 301– 796–5528. For devices regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301–827–6210. I. Background Given the rapid expansion and broad applicability of mobile apps, FDA is issuing this draft guidance to clarify the types of mobile apps to which FDA intends to apply its authority. At this time, FDA intends to apply its regulatory requirements to a subset of mobile apps that the Agency is calling mobile medical apps. For purposes of this guidance, a ‘‘mobile medical app’’ is defined as a mobile app that meets the definition of ‘‘device’’ in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321); 1 and either: 1 Products that are built with or consist of computer and/or software components or applications are subject to regulation as devices when they meet the definition of a device in section 201(h) of the FD&C Act. That provision defines a device as ‘‘* * * an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent * * *,’’ that is ‘‘* * * intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man * * *’’ or ‘‘ * * * intended to affect the structure or any function of the body of man or other animals * * *.’’ PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 43689 • Is used as an accessory to a regulated medical device or • Transforms a mobile platform into a regulated medical device. This narrowly-tailored approach focuses on a subset of mobile apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device. Although some mobile apps that do not meet the definition of mobile medical app may meet the FD&C Act’s definition of a device, the FDA intends to exercise enforcement discretion 2 towards those mobile apps. We welcome comments on all aspects of this guidance as well as the following specific issues: 1. FDA generally considers extensions of medical devices as accessories to those medical devices. Accessories have been typically regulated under the same classification as the connected medical device. However, we recognize potential limitations to this policy for mobile medical apps. FDA seeks comments on how the Agency should approach accessories and particularly mobile medical apps that are accessories to other medical devices so safety and effectiveness can be reasonably assured. For example, one possible approach could be the following: • An accessory that does not change the intended use of the connected device, but aids in the use of the connected medical device could be regulated as class I. For example, such an accessory would be similar to an infusion pump stand, which is currently classified as a class I device because it supports the intended use of an infusion pump (class II medical device). A mobile medical app that simply supports the intended use of a regulated medical device could be classified as class I with design controls as part of the quality systems requirements. • An accessory that extends the intended use of the connected medical device could be classified with the connected device. For example, if a mobile medical app that performs more detailed analysis than the connected medical device while maintaining the original intended use, which is data analysis, could be classified in the same classification as the connected medical device. • An accessory that creates a new intended use from that of the connected 2 This means that FDA intends to exercise its discretion to decline to pursue enforcement actions for violations of the FD&C Act and applicable regulations by a manufacturer of a mobile medical app, as specified in this guidance. This does not constitute a change in the requirements of the FD&C Act or any applicable regulations. E:\FR\FM\21JYN1.SGM 21JYN1 43690 Federal Register / Vol. 76, No. 140 / Thursday, July 21, 2011 / Notices wreier-aviles on DSKDVH8Z91PROD with NOTICES device(s) could be classified according to the risk posed to patient safety by the new intended use, for example, if the intended use of a mobile medical app is to provide prognosis relating to a certain disease or condition and the mobile medical app is connected to a device that does not have that intended use, the mobile medical app may have a different level of risk than the connected device, resulting in a different classification to assure of safety and effectiveness of the mobile medical app. 2. FDA has not addressed in this guidance stand-alone software (mobile or traditional workstation) that analyzes, processes, or interprets medical device data (collected electronically or through manual entry of the device data) for purposes of automatically assessing patient specific data or for providing support in making clinical decisions. FDA plans to address such stand-alone software in a separate guidance. In order to provide a reasonable assurance of the safety and effectiveness of such software, and to ensure consistency between this guidance and the planned guidance on stand-alone software that provides clinical decision support (CDS), FDA is seeking comments on the following issues: • What factors should FDA consider in determining the risk classification of different types of software that provide CDS functionality? Please provide examples of how those factors would be applied for such software that you believe should be in class I, class II, and class III. • How should FDA assess stand-alone software that provides CDS functionality, to assure reasonable safety and effectiveness? For example, to what extent can FDA rely on a manufacturer’s demonstration that it has a robust quality system with appropriate quality assurance and design controls? Under what circumstances should the submission of clinical data be required? • Are there specific controls that manufacturers should implement that could change the risk classification or reduce the premarket data requirements for particular types of stand-alone software that provide CDS functionality? II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on mobile medical applications. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach VerDate Mar<15>2010 15:00 Jul 20, 2011 Jkt 223001 satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at either https://www.regulations.gov or https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/default.htm. To receive ‘‘Mobile Medical Applications’’ from CDRH, you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1741 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved information collections found in FDA regulations. The collections of information in 21 CFR part 801 are approved under OMB control number 0910–0485; the collection of information in 21 CFR part 803 are approved under OMB control number 0910–0437; the collections of information in 21 CFR part 806 are approved under OMB control number 0910–0359; the collections of information in 21 CFR part 807, subpart B, are approved under OMB control number 0910–0387; the collections of information in 21 CFR part 807, subpart E, are approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 820 are approved under OMB control number 0910–0073. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Dated: July 18, 2011. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2011–18537 Filed 7–19–11; 4:15 pm] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0149] (Formerly 2007D–0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Class II Special Controls Guidance Document: Electrocardiograph Electrodes.’’ The special controls identify the following risks to health associated with electrocardiograph electrodes: Adverse tissue reaction to the skin-contacting electrode materials and misdiagnosis. The guidance document provides information on how to mitigate these risks and recommends testing and labeling for these devices. This guidance document describes a means by which electrocardiograph electrodes may comply with the requirement of special controls for class II devices. DATES: Submit either electronic or written comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Class II Special Controls Guidance Document: Electrocardiograph Electrodes’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the SUMMARY: E:\FR\FM\21JYN1.SGM 21JYN1

Agencies

[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Notices]
[Pages 43689-43690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18537]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0530]

Draft Guidance for Industry and Food and Drug Administration
Staff; Mobile Medical Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Mobile Medical
Applications.'' FDA is issuing this draft guidance to inform
manufacturers, distributors, and other entities about how the FDA
intends to apply its regulatory authorities to select software
applications intended for use on mobile platforms (mobile applications
or ``mobile apps''). At this time, FDA intends to apply its regulatory
requirements solely to a subset of mobile apps that the Agency is
calling mobile medical applications (mobile medical apps). This draft
guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 19, 2011

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Mobile Medical Applications'' to the
Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health (CDRH), Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993-0002; or to the Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
For devices regulated by CDRH: Bakul Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-5528.
For devices regulated by CBER: Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852, 301-827-6210.

I. Background

Given the rapid expansion and broad applicability of mobile apps,
FDA is issuing this draft guidance to clarify the types of mobile apps
to which FDA intends to apply its authority. At this time, FDA intends
to apply its regulatory requirements to a subset of mobile apps that
the Agency is calling mobile medical apps. For purposes of this
guidance, a ``mobile medical app'' is defined as a mobile app that
meets the definition of ``device'' in section 201(h) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321); \1\ and
either:
---------------------------------------------------------------------------

\1\ Products that are built with or consist of computer and/or
software components or applications are subject to regulation as
devices when they meet the definition of a device in section 201(h)
of the FD&C Act. That provision defines a device as ``* * * an
instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent * * *,'' that is ``* * * intended for use in the
diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man * * *'' or
`` * * * intended to affect the structure or any function of the
body of man or other animals * * *.''
---------------------------------------------------------------------------

Is used as an accessory to a regulated medical device or
Transforms a mobile platform into a regulated medical
device.
This narrowly-tailored approach focuses on a subset of mobile apps
that either have traditionally been considered medical devices or
affect the performance or functionality of a currently regulated
medical device.
Although some mobile apps that do not meet the definition of mobile
medical app may meet the FD&C Act's definition of a device, the FDA
intends to exercise enforcement discretion \2\ towards those mobile
apps.
---------------------------------------------------------------------------

\2\ This means that FDA intends to exercise its discretion to
decline to pursue enforcement actions for violations of the FD&C Act
and applicable regulations by a manufacturer of a mobile medical
app, as specified in this guidance. This does not constitute a
change in the requirements of the FD&C Act or any applicable
regulations.
---------------------------------------------------------------------------

We welcome comments on all aspects of this guidance as well as the
following specific issues:
1. FDA generally considers extensions of medical devices as
accessories to those medical devices. Accessories have been typically
regulated under the same classification as the connected medical
device. However, we recognize potential limitations to this policy for
mobile medical apps. FDA seeks comments on how the Agency should
approach accessories and particularly mobile medical apps that are
accessories to other medical devices so safety and effectiveness can be
reasonably assured. For example, one possible approach could be the
following:
An accessory that does not change the intended use of the
connected device, but aids in the use of the connected medical device
could be regulated as class I. For example, such an accessory would be
similar to an infusion pump stand, which is currently classified as a
class I device because it supports the intended use of an infusion pump
(class II medical device). A mobile medical app that simply supports
the intended use of a regulated medical device could be classified as
class I with design controls as part of the quality systems
requirements.
An accessory that extends the intended use of the
connected medical device could be classified with the connected device.
For example, if a mobile medical app that performs more detailed
analysis than the connected medical device while maintaining the
original intended use, which is data analysis, could be classified in
the same classification as the connected medical device.
An accessory that creates a new intended use from that of
the connected

[[Page 43690]]

device(s) could be classified according to the risk posed to patient
safety by the new intended use, for example, if the intended use of a
mobile medical app is to provide prognosis relating to a certain
disease or condition and the mobile medical app is connected to a
device that does not have that intended use, the mobile medical app may
have a different level of risk than the connected device, resulting in
a different classification to assure of safety and effectiveness of the
mobile medical app.
2. FDA has not addressed in this guidance stand-alone software
(mobile or traditional workstation) that analyzes, processes, or
interprets medical device data (collected electronically or through
manual entry of the device data) for purposes of automatically
assessing patient specific data or for providing support in making
clinical decisions. FDA plans to address such stand-alone software in a
separate guidance. In order to provide a reasonable assurance of the
safety and effectiveness of such software, and to ensure consistency
between this guidance and the planned guidance on stand-alone software
that provides clinical decision support (CDS), FDA is seeking comments
on the following issues:
What factors should FDA consider in determining the risk
classification of different types of software that provide CDS
functionality? Please provide examples of how those factors would be
applied for such software that you believe should be in class I, class
II, and class III.
How should FDA assess stand-alone software that provides
CDS functionality, to assure reasonable safety and effectiveness? For
example, to what extent can FDA rely on a manufacturer's demonstration
that it has a robust quality system with appropriate quality assurance
and design controls? Under what circumstances should the submission of
clinical data be required?
Are there specific controls that manufacturers should
implement that could change the risk classification or reduce the
premarket data requirements for particular types of stand-alone
software that provide CDS functionality?

II. Significance of Guidance

This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on mobile
medical applications. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at either https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Mobile Medical Applications'' from CDRH, you may either send an e-
mail request to dsmica@fda.hhs.gov to receive an electronic copy of the
document or send a fax request to 301-847-8149 to receive a hard copy.
Please use the document number 1741 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved information
collections found in FDA regulations. The collections of information in
21 CFR part 801 are approved under OMB control number 0910-0485; the
collection of information in 21 CFR part 803 are approved under OMB
control number 0910-0437; the collections of information in 21 CFR part
806 are approved under OMB control number 0910-0359; the collections of
information in 21 CFR part 807, subpart B, are approved under OMB
control number 0910-0387; the collections of information in 21 CFR part
807, subpart E, are approved under OMB control number 0910-0120; and
the collections of information in 21 CFR part 820 are approved under
OMB control number 0910-0073.

V. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: July 18, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18537 Filed 7-19-11; 4:15 pm]
BILLING CODE 4160-01-P

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