GLOBAL MEDICAL DEVICE UPDATE
December 16, 2014
Asia/Pacific
Australia
TGA – Therapeutic Goods Administration
Events
TGA posts presentation given at Australasian Ethics Network Conference
The TGA has posted a presentation given by Dr Tony Gill, Senior Medical Adviser in the agency's Market Authorisation Group at a December 3rd Australasian Ethics Network Conference workshop. The presentation provides an overview of the agency’s role in providing special access to unapproved therapeutic goods and the regulation of clinical trials for drugs and devices.
Read more
Notices
TGA changes banks for user fee payments
The TGA has announced that payments for services provided by the agency must be submitted to the Commonwealth Bank of Australia (CBA) and that the Westpac Banking Corporation (Westpac) account will be closed as of December 23, 2014.
Read more
Recalls/Suspensions
Zimmer recalls bone screws
Zimmer has instituted a recall on unused Trilogy bone screws due to the potential that some lots were prone to fracture.
Read more
Safety Information
TGA issues hazard alert for hip stems
The TGA has issued a hazard alert warning that Biomet Australia’s Sirius Hip Stem 34B and 38C with batch numbers 024320 that are used in hip replacement surgery could have been mixed up during the manufacturing process.
Read more
India
CDSCO – Central Drugs Standard Control Organization
Consultations
CDSCO soliciting feedback on regulatory system upgrade plan
The CDSCO is soliciting feedback on a Ministry of Health and Welfare plan to upgrade the country’s regulatory system at both national and state levels over the next three years, with particular emphasis on the construction of new and the upgrade of existing drug and medical product testing laboratories.
Read more
Japan
PMDA – Pharmaceuticals and Medical Devices Agency
Safety Information
PMDA issues safety notice about venous needles
PMDA’s safety notice provides information on the safe use of Indwelling Venous Needles due to the potential for the plastic outer needle to break and remain in the vein of the patient.
Read more
Korea
MFDS - Ministry of Food and Drug Safety
Consultations
MFDS soliciting input on tissue bank safety management guidance
The MFDS is soliciting comment on tissue bank safety management guidance designed to ensure there is no risk of cross-contamination in tissue processing rooms and facilities.
Read more
Meetings
MFDS posts GMP seminar materials
The MFDS has posted presentations made at the November Medical Device GMP Certification International Seminar.
Read more
Notices
MFDS designates public institutions for device trials
The MFDS has posted the names of the public institutions that are designated to conduct medical device clinical trials.
Read more
Europe
European Commission
Guidance
DG Sanco clarifies scope of Joint Procurement Agreement
The Commission’s Health and Consumers Directorate (DG Sanco) has clarified the scope of the Joint Procurement Agreement that allows EU member states to jointly negotiate the price and supply of vaccines and antiviral medications.
Read more
News
Japan hosts 15th global health meeting
The European Commission participated at the 15th ministerial meeting of the Global Health Security Initiative (GHSI) hosted by Japan in Tokyo on December 11, which brought together health ministers and representatives from Canada, France, Germany, Italy, Japan, UK, US, Mexico, and the World Health Organization.
Read more
Notices
Commission posts update on its response to Ebola
The Commission has posted an update on its response to the West African Ebola outbreak. The update includes mention of a partnership with the European pharmaceutical industry under the Innovative Medicines Initiative, which includes a €280 million call for proposals to support research projects involving clinical trials of new vaccines in Ebola-affected countries, the development of fast diagnostic tests and new approaches to manufacture, store and transport vaccines.
Read more
European Medicines Agency (EMA)
Guidance
Guidance adopted on clinical testing for tissue engineered products
The EMA has adopted a reflection paper that provides guidance on clinical testing for tissue engineered products, and for combined Advanced Therapy Medicinal Products (ATMP) that combine cells or tissues with a medical device.
Read more
France
ANSM - Agence Nationale de Sécurité du Médicament
News
ANSM issues advice on use of mercury-based dental amalgam
ANSM has issued a statement affirming its commitment to significantly reduce the use of mercury-based fillings to treat tooth decay.
Read more
Germany
BfArM – Federal Institute for Drugs and Medical Devices
Safety Information
Two new contra-indications included for laparoscopic tissue morcellation
BfArM has posted information based on recommendations it received from the US Food and Drug Administration on the risks of laparoscopic tissue morcellation in connection with hysterectomy and myomectomy.
Read more
List of safety measures updated
BfArM has updated the list of safety measures taken with respect to medical devices through December 12, 2014.
Read more
IQWiG – Institute for Quality and Efficiency in Health Care
Events
Autumn Symposium 2014: papers and posters online now
On the occasion of its 10th anniversary, IQWiG’s symposium took a look into the future. Discussion centered around the direction that evidence-based care should take, and what IQWiG can contribute to the challenges ahead. The presentations from the symposium are now available online.
Read more
Notified Body Operations Group (NBOG)
Reports
NBOG issues 2014 Progress Report
The NBOG Progress Report for 2014 submitted to the Medical Devices Expert Group (MDEG) highlighted meetings held in February and June concerning the performance and designation of Notified Bodies, with representatives from more than 20 EU Member States, European Free Trade Area (EFTA) countries, MRA partners and the European Commission (including representatives from FVO, the Food and Veterinary Office).
Read more
Spain
AEMPS – Spanish Medicines Agency
Events
AEMPS hosts technical workshop for development of arthroplasty register in Spain
AEMPS and the Spanish Society of Hip Surgery (SECCA) organized a Technical Seminar in order to share experiences on existing Arthroplasty Registers in Europe, with a view to developing a National Arthroplasty Register to monitor the behavior of implants during the time they are in place. The Conference was held on December 3, 2014 at the AEMPS headquarters.
Read more
Switzerland
SwissMedic – Swiss Agency for Therapeutic Products
Recalls/Suspensions
Medical device safety measures updated
Swissmedic's list of medical device recalls and other safety measures has been updated through December 8, 2014.
Read more
United Kingdom
MHRA – Medicines and Healthcare products Regulatory Agency
Notices
Final reminder issued to cancel licenses by the end of December 2014
The MHRA has issued a reminder that holders of authorizations, registrations and licenses are required to notify the agency December 31st to cancel authorizations, registrations and licenses as of March 31, 2015 in order to ensure that they are not liable for a periodic fee in connection with a specific license for the fee period April 1, 2015 to March 31, 2016.
Read more
Safety Information
MHRA issues alert about counterfeit Toshiba ultrasound transducers
The MHRA has issued an alert about counterfeit transducers that were supplied to two hospitals. Although there have been no reports of patient harm, the agency points out that these devices mat not meet the performance standards specified by Toshiba.
Read more
List of new Field Safety Notices posted
The MHRA has posted the list of Field Safety Notices issued in connection with medical device issues during the week of December 1 to December 5, 2014.
Read more
Middle East
Turkey
TITCK - Pharmaceuticals and Medical Devices Agency
Notices
TITCK updates certified testing centers
The TITCK has updated the list of testing centers that have been inspected and certified to conduct bioavailability and bioequivalence testing, and Phase I clinical testing.
Read more
North America
United States
FDA – CBER – Center for Biologics
Approvals/Clearances
CBER updates approvals/clearances
The CBER updated approvals and clearances include an immunoassay test, a quadrivalent flu vaccine, expanded indications for Gardasil 9, a Meningococcal Group B vaccine, and a Measles, Mumps, and Rubella live virus vaccine.
Read more
FDA – CDER – Center for Drugs
Meetings
FDA updates advisory committee calendar
The FDA has updated information concerning advisory committee meetings.
Read more
FDA – CDRH – Center for Devices
Approvals/Clearances
CDRH updates approvals/clearances
The CDRH has posted the 510(k) final decisions that were made in November 2014.
Read more
Guidance
CDRH issues final guidance on passive implants in MR environment
The CDRH has released final guidance on labeling and testing passive implants in the magnetic resonance (MR) environment identifying the main safety and compatibility issues as magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.
Read more
Meetings
CDRH updates advisory committee meeting information
The CDRH has issued a notice of the postponement of the Orthopedic and Rehabilitation Devices Panel December meeting and the addition of the transcript to the November meeting of the Ophthalmic Devices Panel.
Read more
Updated Web Info
CDRH posts Blog on UDI system
The CDRH has posted a Voice Blog by Center Director Jeff Shuren on the critical importance of the implementation of the Unique Device Identifier System (UDI) into health care systems.
Read more
FDA – Food and Drug Administration
Consultations
FDA seeks input on changes to Adverse Event Reporting Forms
The FDA is seeking input on its proposed changes to the adverse event reporting forms 3500, 3500A and 3500B.
Read more
PCORI – Patient Centered Outcomes Research Institute
News
PCORI partners with NIH
The PCORI is partnering with the National Institutes of Health (NIH) to study how to improve blood pressure control among populations at highest risk for suffering hypertension-related strokes, heart attacks, and other cardiovascular events.
Read more
PCORI funds clinical effectiveness research on Hep C
The PCORI Board has approved up to $50 million for up to four comparative clinical effectiveness research (CER) studies on the best ways to diagnose and treat hepatitis C virus infection.
Read more