81_FR_10298 81 FR 10259 - Medical Devices-Quality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action; Public Workshop

81 FR 10259 - Medical Devices-Quality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 39 (February 29, 2016)

Page Range10259-10260
FR Document2016-04221

The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Office, in co-sponsorship with the FDA Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public workshop entitled ``Medical Devices--Quality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action''. The public workshop is intended to seek input from representatives of medical device manufacturers and other stakeholders, on best practices, what has worked for them and what FDA can do to inspire quality efforts. This event will also focus on various topics of interest for those industry representatives who are responsible to insure compliance with FDA regulations.

Federal Register, Volume 81 Issue 39 (Monday, February 29, 2016) 
[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Pages 10259-10260]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04221]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Medical Devices--Quality Systems Survival: Success Strategies for 
Production and Process Controls/Corrective and Preventative Action; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory 
Affairs, Southwest Regional Office, in co-sponsorship with the FDA 
Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public 
workshop entitled ``Medical Devices--Quality Systems Survival: Success 
Strategies for Production and Process Controls/Corrective and 
Preventative Action''. The public workshop is intended to seek input 
from representatives of medical device manufacturers and other 
stakeholders, on best practices, what has worked for them and what FDA 
can do to inspire

[[Page 10260]]

quality efforts. This event will also focus on various topics of 
interest for those industry representatives who are responsible to 
insure compliance with FDA regulations.

DATES: The meeting will be held on April 15, 2016, from 8 a.m. to 5 
p.m.

ADDRESSES: The meeting will be held at Courtyard and Towne Place Suites 
by Marriott, DFW Airport North/Grapevine, 2200 Bass Pro Ct., Grapevine, 
TX 76051. Directions and lodging information are available at the 
FMDIC, Inc. Web site at http://www.fmdic.org/.

FOR FURTHER INFORMATION CONTACT: Staci McAllister, Consumer Safety 
Technician, Food and Drug Administration, 4040 N. Central Expressway, 
Suite 300, Dallas, TX 75204, 214-253-5259, FAX: 214-253-5314, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The workshop is being held in response to the interest in the 
topics discussed from small medical device manufacturers in the Dallas 
District area. This workshop helps achieve objectives set forth in 
section 406 of the Food and Drug Administration Modernization Act of 
1997 (21 U.S.C. 393), which include working closely with stakeholders 
and maximizing the availability and clarity of information to 
stakeholders and the public. This workshop is also consistent with the 
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 
104-121) as an outreach activity by Government agencies to small 
businesses.
    The goal of the public workshop is to present information that will 
enable manufacturers and regulated industry to better comply with FDA's 
medical device requirements. Please visit the http://www.fmdic.org/ Web 
site for the agenda and for information about the presenters at the 
workshop.

II. Participation in the Public Workshop

    Registration: FMDIC has early registration ($250 for industry/$150 
for government with ID/$50 for students) available until March 14, 
2016. Registration after March 14, 2016, increases to $300 for 
industry, $200 for government with ID, with student registration 
staying the same, at $50. To register online, please visit http://www.fmdic.org/. As an alternative, send the registration information 
including the registrant's name, title, organization, address, 
telephone and fax numbers, and email address (for each registrant), 
along with a check or money order (covering all registration fees) 
payable to the FMDIC, Inc., to FMDIC Registrar, 4447 N. Central 
Expressway, Suite 110 PMB197, Dallas, TX 75205. FMDIC, Inc. accepts 
registrations onsite on the day of the event beginning at 7:30 a.m. at 
the regular registration fee stated above. Registration on site will be 
accepted on a space available basis on the day of the public workshop 
beginning at 7:30 a.m. Please note that due to popularity, similar past 
events have reached maximum capacity well before the day of the event. 
The cost of registration at the site is $300 payable to the FMDIC, Inc. 
The registration fee will be used to offset expenses of hosting the 
event, including continental breakfast, lunch, audiovisual equipment, 
venue, materials, and other logistics associated with this event.
    If you need special accommodations due to a disability, please 
contact Staci McAllister (see FOR FURTHER INFORMATION CONTACT) at least 
7 days in advance.
    Transcripts: Transcripts of the public workshop will not be 
available due to the format of this workshop.

    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04221 Filed 2-26-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices 10259 survey, respondents will be randomly characteristics such as demographics, nonresponse. We will examine the assigned to view one of two ads for insurance coverage, and prescription frequencies for survey items and the fictional prescription drugs intended to drug use. The survey is available upon relation between survey items and treat high cholesterol. They will be request. demographic and health characteristics. asked questions about FDA’s authority We will test for any differences We also plan to compare responses regarding specific claims within the ad. between modes (online versus mail between this survey and FDA’s 2002 The survey will include a debriefing to survey) and will account for any mode survey for repeated items. inform respondents that the advertised effects in our analyses. We will weigh drug was fictitious. We will also the data to account for different FDA estimates the burden of this measure other potentially important probability of selection and collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Number of Total annual Average burden Activity responses per Total hours respondents responses per response respondent Pilot Study Survey invitation letter .......................................... 100 1 100 .08 (5 min.) .................... 8 Reminder postcard ............................................... 100 1 100 .03 (2 min.) .................... 3 Non-response letter .............................................. 82 1 82 .08 (5 min.) .................... 7 Non-response questionnaire letter ....................... 81 1 81 .08 (5 min.) .................... 7 Second postcard .................................................. 60 1 60 .03 (2 min.) .................... 2 Survey .................................................................. 35 1 35 .33 (20 min.) .................. 12 Main Study Survey invitation letter .......................................... 5,042 1 5,042 .08 (5 min.) .................... 403 Reminder postcard ............................................... 5,042 1 5,042 .03 (2 min.) .................... 151 Non-response letter .............................................. 4,173 1 4,173 .08 (5 min.) .................... 334 Non-response questionnaire letter ....................... 4,073 1 4,073 .08 (5 min.) .................... 326 Second postcard .................................................. 3,063 1 3,063 .03 (2 min.) .................... 92 Survey .................................................................. 1,765 1 1,765 .33 (20 min.) .................. 582 Total .............................................................. ........................ ........................ ........................ ....................................... 1927 1 There are no capital costs or operating and maintenance costs associated with this collection of information. References 4. American Association for Public Opinion DEPARTMENT OF HEALTH AND Research, ‘‘Address-based Sampling’’ HUMAN SERVICES The following references are on (2016). (http://www.aapor.org/AAPOR_ display in the Division of Dockets Main/media/MainSiteFiles/AAPOR_ Food and Drug Administration Management (see ADDRESSES) and are Report_1_7_16_CLEAN–COPY– available for viewing by interested FINAL.pdf). [Docket No. FDA–2016–N–0001] persons between 9 a.m. and 4 p.m., 5. Millar, M.M. and D.A. Dillman, Monday through Friday; they are also ‘‘Improving Response to Web and Mixed- Medical Devices—Quality Systems available electronically at http:// Mode Surveys,’’ Public Opinion Survival: Success Strategies for www.regulations.gov. FDA has verified Quarterly 1–21 (2011). Production and Process Controls/ the Web site addresses, as of the date 6. Shaw, M.J., T.J. Beebe, H.L. Jensen, and Corrective and Preventative Action; this document publishes in the Federal S.A. Adlis, ‘‘The Use of Monetary Public Workshop Register, but Web sites are subject to Incentives in a Community Survey: AGENCY: Food and Drug Administration, change over time. Impact on Response Rates, Data Quality, HHS. 1. Aikin, K.J., J.L. Swasy, and A.C. Braman, and Cost,’’ Health Services Research 35:1339–1346 (2011). ACTION: Notice of public workshop. ‘‘Patient and Physician Attitudes and Behaviors Associated With DTC 7. Montaquila, J.M., J.M. Brick, D. Williams, SUMMARY: The Food and Drug Promotion of Prescription Drugs— K. Kim, et al., ‘‘A Study of Two-Phase Administration (FDA), Office of Summary of FDA Survey Research Mail Survey Data Collection Methods, Results’’ (2004). (http://www.fda.gov/ Regulatory Affairs, Southwest Regional Journal of Survey Statistics and downloads/Drugs/ScienceResearch/ Office, in co-sponsorship with the FDA Methodology 1(1), 66–87 (2013). ResearchAreas/DrugMarketing Medical Device Industry Coalition, Inc. AdvertisingandCommunications Dated: February 23, 2016. (FMDIC), is announcing a public Research/ucm152860.pdf). Leslie Kux, workshop entitled ‘‘Medical Devices— 2. PhRMA Guiding Principles: Direct-to- Quality Systems Survival: Success asabaliauskas on DSK5VPTVN1PROD with NOTICES Associate Commissioner for Policy. Consumer Advertisements About Strategies for Production and Process [FR Doc. 2016–04220 Filed 2–26–16; 8:45 am] Prescription Medicines (2008). (http:// Controls/Corrective and Preventative phrma.org/sites/default/files/pdf/phrma BILLING CODE 4164–01–P Action’’. The public workshop is guidingprinciplesdec08final.pdf). 3. Dillman, D.A., J.D. Smyth, and L.M. intended to seek input from Christian, Internet, Phone, Mail, and representatives of medical device Mixed-Mode Surveys: The Tailored manufacturers and other stakeholders, Design Method, 4th ed. Hoboken, NJ: on best practices, what has worked for John Wiley & Sons, Inc. (2014). them and what FDA can do to inspire VerDate Sep<11>2014 19:23 Feb 26, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\29FEN1.SGM 29FEN1

10260 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices quality efforts. This event will also the FMDIC, Inc., to FMDIC Registrar, please see the SUPPLEMENTARY focus on various topics of interest for 4447 N. Central Expressway, Suite 110 INFORMATION section. those industry representatives who are PMB197, Dallas, TX 75205. FMDIC, Inc. ADDRESSES: You may submit comments responsible to insure compliance with accepts registrations onsite on the day of as follows: FDA regulations. the event beginning at 7:30 a.m. at the DATES: The meeting will be held on regular registration fee stated above. Electronic Submissions April 15, 2016, from 8 a.m. to 5 p.m. Registration on site will be accepted on Submit electronic comments in the ADDRESSES: The meeting will be held at a space available basis on the day of the following way: Courtyard and Towne Place Suites by public workshop beginning at 7:30 a.m. • Federal eRulemaking Portal: http:// Marriott, DFW Airport North/Grapevine, Please note that due to popularity, www.regulations.gov. Follow the 2200 Bass Pro Ct., Grapevine, TX 76051. similar past events have reached instructions for submitting comments. Directions and lodging information are maximum capacity well before the day Comments submitted electronically, available at the FMDIC, Inc. Web site at of the event. The cost of registration at including attachments, to http:// http://www.fmdic.org/. the site is $300 payable to the FMDIC, www.regulations.gov will be posted to FOR FURTHER INFORMATION CONTACT: Inc. The registration fee will be used to the docket unchanged. Because your Staci McAllister, Consumer Safety offset expenses of hosting the event, comment will be made public, you are Technician, Food and Drug including continental breakfast, lunch, solely responsible for ensuring that your Administration, 4040 N. Central audiovisual equipment, venue, comment does not include any Expressway, Suite 300, Dallas, TX materials, and other logistics associated confidential information that you or a 75204, 214–253–5259, FAX: 214–253– with this event. third party may not wish to be posted, 5314, staci.mcallister@fda.hhs.gov. If you need special accommodations such as medical information, your or due to a disability, please contact Staci anyone else’s Social Security number, or SUPPLEMENTARY INFORMATION: McAllister (see FOR FURTHER confidential business information, such I. Background INFORMATION CONTACT) at least 7 days in as a manufacturing process. Please note The workshop is being held in advance. that if you include your name, contact response to the interest in the topics Transcripts: Transcripts of the public information, or other information that discussed from small medical device workshop will not be available due to identifies you in the body of your manufacturers in the Dallas District the format of this workshop. comments, that information will be area. This workshop helps achieve Dated: February 23, 2016. posted on http://www.regulations.gov. objectives set forth in section 406 of the Leslie Kux, • If you want to submit a comment Food and Drug Administration Associate Commissioner for Policy. with confidential information that you Modernization Act of 1997 (21 U.S.C. [FR Doc. 2016–04221 Filed 2–26–16; 8:45 am] do not wish to be made available to the 393), which include working closely BILLING CODE 4164–01–P public, submit the comment as a with stakeholders and maximizing the written/paper submission and in the availability and clarity of information to manner detailed (see ‘‘Written/Paper stakeholders and the public. This DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘ Instructions’’). workshop is also consistent with the HUMAN SERVICES Written/Paper Submissions Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121) Food and Drug Administration Submit written/paper submissions as as an outreach activity by Government follows: [Docket No. FDA–2016–D–0631] agencies to small businesses. • Mail/Hand delivery/Courier (for The goal of the public workshop is to Requirements for Transactions With written/paper submissions): Division of present information that will enable First Responders Under Section 582 of Dockets Management (HFA–305), Food manufacturers and regulated industry to the Federal Food, Drug, and Cosmetic and Drug Administration, 5630 Fishers better comply with FDA’s medical Act—Compliance Policy; Guidance for Lane, Rm. 1061, Rockville, MD 20852. device requirements. Please visit the Industry; Availability • For written/paper comments http://www.fmdic.org/ Web site for the submitted to the Division of Dockets agenda and for information about the AGENCY: Food and Drug Administration, Management, FDA will post your presenters at the workshop. HHS. comment, as well as any attachments, ACTION: Notice of availability. except for information submitted, II. Participation in the Public marked and identified, as confidential, Workshop SUMMARY: The Food and Drug if submitted as detailed in Registration: FMDIC has early Administration (FDA or we) is ‘‘Instructions.’’ registration ($250 for industry/$150 for announcing the availability of a Instructions: All submissions received government with ID/$50 for students) guidance for industry entitled must include the Docket No. FDA– available until March 14, 2016. ‘‘Requirements for Transactions with 2016–D–0631 for ‘‘Requirements for Registration after March 14, 2016, First Responders under Section 582 of Transactions with First Responders increases to $300 for industry, $200 for the Federal Food, Drug, and Cosmetic under Section 582 of the Federal Food, government with ID, with student Act—Compliance Policy.’’ This Drug, and Cosmetic Act—Compliance registration staying the same, at $50. To guidance describes FDA’s compliance Policy; Guidance for Industry.’’ asabaliauskas on DSK5VPTVN1PROD with NOTICES register online, please visit http:// policy regarding certain requirements in Received comments will be placed in www.fmdic.org/. As an alternative, send the Federal Food, Drug, and Cosmetic the docket and, except for those the registration information including Act (the FD&C Act) for trading partners submitted as ‘‘Confidential the registrant’s name, title, organization, engaged in transactions with first Submissions,’’ publicly viewable at address, telephone and fax numbers, responders. This compliance policy is http://www.regulations.gov or at the and email address (for each registrant), in effect until further notice by FDA. Division of Dockets Management along with a check or money order DATES: Effective February 29, 2016. For between 9 a.m. and 4 p.m., Monday (covering all registration fees) payable to information about enforcement dates, through Friday. VerDate Sep<11>2014 19:23 Feb 26, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\29FEN1.SGM 29FEN1


Document Created: 2016-02-27 02:05:23
Document Modified: 2016-02-27 02:05:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop.
DatesThe meeting will be held on April 15, 2016, from 8 a.m. to 5 p.m.
ContactStaci McAllister, Consumer Safety Technician, Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, 214-253-5259, FAX: 214-253-5314, [email protected]
FR Citation81 FR 10259 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR