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)

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


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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.

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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