Medical

Main information

  • Trade name:
  • Medical device cleaning/disinfecting wipe
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Medical device cleaning/disinfecting wipe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218938
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218938

AMCLA Pty Ltd - Medical device cleaning/disinfecting wipe

ARTG entry for

Medical Device Included Class IIb

Sponsor

AMCLA Pty Ltd

Postal Address

PO Box 1215,MORNINGTON, VIC, 3931

Australia

ARTG Start Date

6/01/2014

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Gama Healthcare Ltd

2 Regal Way

, Watford, WD24 4YJ

United Kingdom

Products

1. Medical device cleaning/disinfecting wipe

Product Type

Single Device Product

Effective date

6/01/2014

GMDN

58077 Medical device cleaning/disinfecting wipe

Intended purpose

The wipes are intended to be used for the surface disinfection of non-invasive medical devices including

but not limited to IV Accessports; hubs & connectors.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 08:59:43 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

15-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions

The FDA is working to further evaluate materials like metals that are used in medical devices to learn more about how these materials interact with the immune system.

FDA - U.S. Food and Drug Administration

7-3-2019

Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

Norbrook Laboratories Limited of Newry, Northern Ireland is recalling two lots of Enroflox® 100 Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin) and two lots of Ivermax® 1% Injection (ivermectin) to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal. This may result in ...

FDA - U.S. Food and Drug Administration

1-3-2019

New EU report on big data paves the way for action

New EU report on big data paves the way for action

A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.

Danish Medicines Agency

26-2-2019

ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate

ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate

ICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock™ and ChemoClave® Vial Spikes due to the potential for burr particulate originating from the protective cap used in the assembly of the device

FDA - U.S. Food and Drug Administration

25-2-2019

AEDs: How These Devices in Public Places Can Restart Hearts

AEDs: How These Devices in Public Places Can Restart Hearts

If cardiac arrest occurs, rapid treatment with a medical device called an automated external defibrillator, or 'AED' for short, can be life-saving. Learn how FDA works to help ensure they are safe and effective.

FDA - U.S. Food and Drug Administration

25-2-2019

FDA-Approved Devices That Keep the Heart Beating

FDA-Approved Devices That Keep the Heart Beating

Cardiovascular devices (or 'heart' devices) such as pacemakers and defibrillators have extended and improved the lives of millions of people worldwide. Learn how the FDA regulates these devices, when to seek medical attention for potential heart issues, and how to report problems.

FDA - U.S. Food and Drug Administration

8-2-2019

New data analysis centre to open at the Danish Medicines Agency

New data analysis centre to open at the Danish Medicines Agency

The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.

Danish Medicines Agency

1-2-2019

FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

Medical product distributor issued voluntary recall of certain Roche Diagnostics test strips used with CoaguChek test meter devices.

FDA - U.S. Food and Drug Administration

31-1-2019

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

FDA - U.S. Food and Drug Administration

30-1-2019

Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDE-5 Inhibitors in the Product

Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDE-5 Inhibitors in the Product

Nature’s Rx is voluntarily recalling quantity lots of Silver Bullet 10x, description of dosage form to the hospital, retail or consumer level. This recall has been initiated because the product was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared PDE-5 inhibitors in the product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that the...

FDA - U.S. Food and Drug Administration

23-1-2019

DKMA Update December 2018

DKMA Update December 2018

In this issue of DKMA Update you can read about safety for medical devices; new biosimilar medicines for Humira; better conditions for clinical trials in Denmark; new front page for our website and much more

Danish Medicines Agency

21-12-2018

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

Teva Canada is voluntarily recalling one lot (Lot 150261) of two products because of a labelling error. While the outer carton of Equate brand Lens Care System is correctly labelled, the bottle within the carton is mislabelled as Equate brand Multi-Purpose Solution. Because of the labelling error, the company is recalling both products labelled with Lot 150261. Bottles labelled as Equate Multi-Purpose Solution should contain a 0.0001% w/v polyhexanide based disinfecting solution for rinsing. The mislabel...

Health Canada

22-3-2019

#ICYMI #FDA #MedicalDevice https://twitter.com/FDASpox/status/1108799685748113408 …

#ICYMI #FDA #MedicalDevice https://twitter.com/FDASpox/status/1108799685748113408 …

#ICYMI #FDA #MedicalDevice https://twitter.com/FDASpox/status/1108799685748113408 …

FDA - U.S. Food and Drug Administration

22-3-2019

On March 21st, the @US_FDA issued a safety communication about  #cybersecurity vulnerabilities with Medtronic’s implanted cardiac devices, clinic programmers, and home monitors. Find out more about the safety communication:  https://go.usa.gov/xEtdR  #Med

On March 21st, the @US_FDA issued a safety communication about #cybersecurity vulnerabilities with Medtronic’s implanted cardiac devices, clinic programmers, and home monitors. Find out more about the safety communication: https://go.usa.gov/xEtdR  #Med

On March 21st, the @US_FDA issued a safety communication about #cybersecurity vulnerabilities with Medtronic’s implanted cardiac devices, clinic programmers, and home monitors. Find out more about the safety communication: https://go.usa.gov/xEtdR  #MedicalDevice #FDA pic.twitter.com/nVL2KMagyA

FDA - U.S. Food and Drug Administration

22-3-2019

On March 18th, the @US_FDA identified a Class I Recall, the most serious  type of recall: Cook Medical Inc. Recalls Transseptal Needle Due to  Risk of Detached Plastic Fragments. Find out more about the recall:  https://go.usa.gov/xEtdg  #FDA #MedicalDevi

On March 18th, the @US_FDA identified a Class I Recall, the most serious type of recall: Cook Medical Inc. Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments. Find out more about the recall: https://go.usa.gov/xEtdg  #FDA #MedicalDevi

On March 18th, the @US_FDA identified a Class I Recall, the most serious type of recall: Cook Medical Inc. Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments. Find out more about the recall: https://go.usa.gov/xEtdg  #FDA #MedicalDevice pic.twitter.com/JasosItjFN

FDA - U.S. Food and Drug Administration

21-3-2019

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast:  https://bit.ly/2WgkmGC   March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0   #FDA #MedicalDevicepic.twitter.com/zvhd7

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast: https://bit.ly/2WgkmGC  March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0  #FDA #MedicalDevicepic.twitter.com/zvhd7

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast: https://bit.ly/2WgkmGC  March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0  #FDA #MedicalDevice pic.twitter.com/zvhd72SyxX

FDA - U.S. Food and Drug Administration

21-3-2019

The #FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. #FDA #MedicalDevice

The #FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. #FDA #MedicalDevice

The #FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-3-2019

The committee will discuss and make recommendations regarding the benefits and risks of #BreastImplants. Meeting materials are now available:  https://go.usa.gov/xEehs  #FDA #MedicalDevice

The committee will discuss and make recommendations regarding the benefits and risks of #BreastImplants. Meeting materials are now available: https://go.usa.gov/xEehs  #FDA #MedicalDevice

The committee will discuss and make recommendations regarding the benefits and risks of #BreastImplants. Meeting materials are now available: https://go.usa.gov/xEehs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-3-2019

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevicepic.twitter.com/Wh9Sshjn6n

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevicepic.twitter.com/Wh9Sshjn6n

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevice pic.twitter.com/Wh9Sshjn6n

FDA - U.S. Food and Drug Administration

20-3-2019

Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices

Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices

Additional Q&A's on use of market authorisation evidence from overseas regulatory bodies for medical devices

Therapeutic Goods Administration - Australia

18-3-2019

Today is the last day to provide comments on the draft guidance: Content of Premarket Submissions for Management of #Cybersecurity in #MedicalDevices. Submit comments here:  https://go.usa.gov/xE6jm  #DigitalHealth #HealthTechpic.twitter.com/EEyI1OErRY

Today is the last day to provide comments on the draft guidance: Content of Premarket Submissions for Management of #Cybersecurity in #MedicalDevices. Submit comments here: https://go.usa.gov/xE6jm  #DigitalHealth #HealthTechpic.twitter.com/EEyI1OErRY

Today is the last day to provide comments on the draft guidance: Content of Premarket Submissions for Management of #Cybersecurity in #MedicalDevices. Submit comments here: https://go.usa.gov/xE6jm  #DigitalHealth #HealthTech pic.twitter.com/EEyI1OErRY

FDA - U.S. Food and Drug Administration

15-3-2019

We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.  https://go.usa.gov/

We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. https://go.usa.gov/

We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. https://go.usa.gov/xE6Ws 

FDA - U.S. Food and Drug Administration

15-3-2019

#FDA CDRH is responsible for protecting and promoting the public health.  We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.  #MedicalDevice

#FDA CDRH is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. #MedicalDevice

#FDA CDRH is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. #MedicalDevice

FDA - U.S. Food and Drug Administration

15-3-2019

Today @US_FDA issued an update to a letter to health care providers regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons & paclitaxel-eluting stents to treat peripheral arterial disease:  https://go.usa.gov/xE6

Today @US_FDA issued an update to a letter to health care providers regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons & paclitaxel-eluting stents to treat peripheral arterial disease: https://go.usa.gov/xE6

Today @US_FDA issued an update to a letter to health care providers regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons & paclitaxel-eluting stents to treat peripheral arterial disease: https://go.usa.gov/xE6Wx  #MedicalDevice #FDA pic.twitter.com/ywPS48OwEV

FDA - U.S. Food and Drug Administration

14-3-2019

Follow the #FDA and @CDCgov to stay informed on contact lens safety  https://go.usa.gov/xEHZD  #MedicalDevicepic.twitter.com/gYibolsVzN

Follow the #FDA and @CDCgov to stay informed on contact lens safety https://go.usa.gov/xEHZD  #MedicalDevicepic.twitter.com/gYibolsVzN

Follow the #FDA and @CDCgov to stay informed on contact lens safety https://go.usa.gov/xEHZD  #MedicalDevice pic.twitter.com/gYibolsVzN

FDA - U.S. Food and Drug Administration

8-3-2019

Today, the @US_FDA issued a Letter to Healthcare Providers about the increasing number of adverse events associated with surgical staplers for internal use. Read more about the #FDA's recommendations:  https://go.usa.gov/xEGS5  #MedicalDevicepic.twitter.c

Today, the @US_FDA issued a Letter to Healthcare Providers about the increasing number of adverse events associated with surgical staplers for internal use. Read more about the #FDA's recommendations: https://go.usa.gov/xEGS5  #MedicalDevicepic.twitter.c

Today, the @US_FDA issued a Letter to Healthcare Providers about the increasing number of adverse events associated with surgical staplers for internal use. Read more about the #FDA's recommendations: https://go.usa.gov/xEGS5  #MedicalDevice pic.twitter.com/WkmB2yKqUz

FDA - U.S. Food and Drug Administration

8-3-2019

“#DYK Contact lenses are #MedicalDevices? #SpringIntoAction and Check out the @US_FDA’s 7 tips for using contact lenses safely:  https://www.youtube.com/watch?v=ULEuOEEs0AE&feature=youtu.be … …” #FDA #MedicalDevice

“#DYK Contact lenses are #MedicalDevices? #SpringIntoAction and Check out the @US_FDA’s 7 tips for using contact lenses safely: https://www.youtube.com/watch?v=ULEuOEEs0AE&feature=youtu.be … …” #FDA #MedicalDevice

“ #DYK Contact lenses are #MedicalDevices? #SpringIntoAction and Check out the @US_FDA’s 7 tips for using contact lenses safely: https://www.youtube.com/watch?v=ULEuOEEs0AE&feature=youtu.be … …” #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

6-3-2019

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more:  https://go.usa.gov/xEfkX  #MedicalDev

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more: https://go.usa.gov/xEfkX  #MedicalDev

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more: https://go.usa.gov/xEfkX  #MedicalDevice #FDA pic.twitter.com/WZZjTq0BMX

FDA - U.S. Food and Drug Administration

6-3-2019

Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

This consultation considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed changes to the classification of active implantable medical devices and their accessories

Consultation: Proposed changes to the classification of active implantable medical devices and their accessories

This consultation considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

5-3-2019

If you get sick with #flu, make sure to take steps for a quick, healthy recovery. 

Stay home and rest, and avoid close contact with others except if you need medical care. Learn more about how to #fightflu this season.  https://bit.ly/2m6lwaM pic.twitter

If you get sick with #flu, make sure to take steps for a quick, healthy recovery. Stay home and rest, and avoid close contact with others except if you need medical care. Learn more about how to #fightflu this season. https://bit.ly/2m6lwaM pic.twitter

If you get sick with #flu, make sure to take steps for a quick, healthy recovery. Stay home and rest, and avoid close contact with others except if you need medical care. Learn more about how to #fightflu this season. https://bit.ly/2m6lwaM  pic.twitter.com/OnpBJLgajA

FDA - U.S. Food and Drug Administration

28-2-2019

Today @US_FDA issued a safety communication to providers and patients  about the use of robotically-assisted surgical devices for mastectomy  and other cancer related surgeries. Read more here:  https://go.usa.gov/xEpub?utm_source=CDRHTwitterD …  #Medical

Today @US_FDA issued a safety communication to providers and patients about the use of robotically-assisted surgical devices for mastectomy and other cancer related surgeries. Read more here: https://go.usa.gov/xEpub?utm_source=CDRHTwitterD … #Medical

Today @US_FDA issued a safety communication to providers and patients about the use of robotically-assisted surgical devices for mastectomy and other cancer related surgeries. Read more here: https://go.usa.gov/xEpub?utm_source=CDRHTwitterD … #MedicalDevice pic.twitter.com/MitGy4EuFh

FDA - U.S. Food and Drug Administration

28-2-2019

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link:  https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonthpic.twitter.com/fmj3uU8yb7

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link: https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonthpic.twitter.com/fmj3uU8yb7

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link: https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonth pic.twitter.com/fmj3uU8yb7

FDA - U.S. Food and Drug Administration

26-2-2019

TGA presentation: Stakeholder Workshop held in TGA, Symonston, 8 February 2019

TGA presentation: Stakeholder Workshop held in TGA, Symonston, 8 February 2019

This presentation highlights some of the concerns related to system or procedure pack medical devices.

Therapeutic Goods Administration - Australia

22-2-2019

A5: #FDA funds $6M/yr for the Pediatric Device Consortia Grants Program – a program to provide advice and support services to advance innovation in medical devices for children.  http://go.usa.gov/cpygz  #NIHChat

A5: #FDA funds $6M/yr for the Pediatric Device Consortia Grants Program – a program to provide advice and support services to advance innovation in medical devices for children. http://go.usa.gov/cpygz  #NIHChat

A5: #FDA funds $6M/yr for the Pediatric Device Consortia Grants Program – a program to provide advice and support services to advance innovation in medical devices for children. http://go.usa.gov/cpygz  #NIHChat

FDA - U.S. Food and Drug Administration

15-2-2019

#ICYMI: On February 14th, @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error. Find out more about the recall:  https://go.usa.gov/xEU

#ICYMI: On February 14th, @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error. Find out more about the recall: https://go.usa.gov/xEU

#ICYMI: On February 14th, @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error. Find out more about the recall: https://go.usa.gov/xEUhq  #MedicalDevice #FDA pic.twitter.com/YNkrpGSOhH

FDA - U.S. Food and Drug Administration

15-2-2019

#ICYMI: FDA authorizes first interoperable insulin pump intended to  allow patients to customize treatment through their individual diabetes  management devices. Read more here:  https://go.usa.gov/xEUuM   #MedicalDevice #FDA

#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM  #MedicalDevice #FDA

#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

15-2-2019

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here:  https://go.usa.gov/xEUeu  #Medi

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #Medi

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

13-2-2019

Consultation: Regulation of software, including Software as a Medical Device (SaMD)

Consultation: Regulation of software, including Software as a Medical Device (SaMD)

The TGA is seeking feedback on how software, including Software as a Medical Device, is regulated in Australia. Closing date: 31 March 2019

Therapeutic Goods Administration - Australia

12-2-2019

Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

The TGA is seeking feedback on how personalised medical devices are regulated in Australia. Closing date: 31 March 2019

Therapeutic Goods Administration - Australia

12-2-2019

Webinar: Regulation of Software as a Medical Device (SaMD)

Webinar: Regulation of Software as a Medical Device (SaMD)

This webinar provides an overview of how the TGA regulates medical devices, with a focus on SaMD products

Therapeutic Goods Administration - Australia

11-2-2019

Consultation: Proposed reclassification of spinal implantable medical devices

Consultation: Proposed reclassification of spinal implantable medical devices

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 31 March 2019

Therapeutic Goods Administration - Australia

8-2-2019

#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA  's Center for Devices and Radiological Health on the agency’s continuing efforts to educate patients on known risk of lymphoma from breast  implants:  https://go.usa.gov/xERN3   #MedicalDevic

#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA 's Center for Devices and Radiological Health on the agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants: https://go.usa.gov/xERN3  #MedicalDevic

#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA 's Center for Devices and Radiological Health on the agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants: https://go.usa.gov/xERN3  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

8-2-2019

On February 5th, @US_FDA identified a Class I Recall, the most serious type of recall: Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of Lumens. Find out more about the recall:  https://go.usa.gov

On February 5th, @US_FDA identified a Class I Recall, the most serious type of recall: Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of Lumens. Find out more about the recall: https://go.usa.gov

On February 5th, @US_FDA identified a Class I Recall, the most serious type of recall: Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of Lumens. Find out more about the recall: https://go.usa.gov/xER5f  #FDA #MedicalDevice pic.twitter.com/6adzC2txTv

FDA - U.S. Food and Drug Administration

6-2-2019

Today, the @US_FDA issued a Letter to Healthcare Providers about diagnosing and treating BIA-ALCL. Click to read more about the #FDA's recommendations:  https://go.usa.gov/xENj4  #MedicalDevicepic.twitter.com/szwLQ8FvxA

Today, the @US_FDA issued a Letter to Healthcare Providers about diagnosing and treating BIA-ALCL. Click to read more about the #FDA's recommendations: https://go.usa.gov/xENj4  #MedicalDevicepic.twitter.com/szwLQ8FvxA

Today, the @US_FDA issued a Letter to Healthcare Providers about diagnosing and treating BIA-ALCL. Click to read more about the #FDA's recommendations: https://go.usa.gov/xENj4  #MedicalDevice pic.twitter.com/szwLQ8FvxA

FDA - U.S. Food and Drug Administration

4-2-2019

On January 28th, @US_FDA  identified a Class I Recall, the most serious  type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid  Transfer Systems Due to Potential Malfunctions. Find out more about the recall here:  https://go.usa.gov/xEX

On January 28th, @US_FDA identified a Class I Recall, the most serious type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions. Find out more about the recall here: https://go.usa.gov/xEX

On January 28th, @US_FDA identified a Class I Recall, the most serious type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions. Find out more about the recall here: https://go.usa.gov/xEXHM  #FDA #MedicalDevice pic.twitter.com/0l5O1bSaUy

FDA - U.S. Food and Drug Administration

1-2-2019

#ICYMI #FDA #MedicalDevice https://twitter.com/SGottliebFDA/status/1090564837187424258 …

#ICYMI #FDA #MedicalDevice https://twitter.com/SGottliebFDA/status/1090564837187424258 …

#ICYMI #FDA #MedicalDevice https://twitter.com/SGottliebFDA/status/1090564837187424258 …

FDA - U.S. Food and Drug Administration

31-1-2019

Today @US_FDA issued a safety communication to providers and patients  about the risks of air-in-line when using infusion pumps, rapid  infusers, and fluid warmers. Find out more about the risks and #FDA  recommendations:  https://go.usa.gov/xE9g7  ##Medi

Today @US_FDA issued a safety communication to providers and patients about the risks of air-in-line when using infusion pumps, rapid infusers, and fluid warmers. Find out more about the risks and #FDA recommendations: https://go.usa.gov/xE9g7  ##Medi

Today @US_FDA issued a safety communication to providers and patients about the risks of air-in-line when using infusion pumps, rapid infusers, and fluid warmers. Find out more about the risks and #FDA recommendations: https://go.usa.gov/xE9g7  # #MedicalDevice pic.twitter.com/lLIyoG6680

FDA - U.S. Food and Drug Administration

31-1-2019

TGA statutory advisory committees

TGA statutory advisory committees

New membership of Advisory Committee on Medicines, Advisory Committee on Medical Devices and Advisory Committee on Vaccines

Therapeutic Goods Administration - Australia

29-1-2019

On January 23rd, @US_FDA identified a Class I Recall, the most serious type of recall: Draeger Medical Recalls Breathing Circuits and Anesthesia Sets. Read more about the recall:  https://go.usa.gov/xEktQ  #FDA #MedicalDevicepic.twitter.com/cJYfk0FUiR

On January 23rd, @US_FDA identified a Class I Recall, the most serious type of recall: Draeger Medical Recalls Breathing Circuits and Anesthesia Sets. Read more about the recall: https://go.usa.gov/xEktQ  #FDA #MedicalDevicepic.twitter.com/cJYfk0FUiR

On January 23rd, @US_FDA identified a Class I Recall, the most serious type of recall: Draeger Medical Recalls Breathing Circuits and Anesthesia Sets. Read more about the recall: https://go.usa.gov/xEktQ  #FDA #MedicalDevice pic.twitter.com/cJYfk0FUiR

FDA - U.S. Food and Drug Administration

29-1-2019

On January 23rd, @US_FDA permitted the marketing of first test to aid in  the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium. For more information, read the press release here:  https://go.usa.gov/xEkt3  #FDA #MedicalDevice

On January 23rd, @US_FDA permitted the marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium. For more information, read the press release here: https://go.usa.gov/xEkt3  #FDA #MedicalDevice

On January 23rd, @US_FDA permitted the marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium. For more information, read the press release here: https://go.usa.gov/xEkt3  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

7-1-2019

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

The TGA is seeking your comments on the proposal to introduce new and amended definitions, and a revised scope of the products regulated as medical devices in Australia. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

7-1-2019

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

The TGA seeks comments on the extent to which a similar approach will be appropriate in the Australian regulatory context. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

7-1-2019

Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia

Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia

We seek your views on the proposed regulatory changes that would facilitate the adoption of the internationally harmonised principles for introduction of the UDI system in Australia. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

21-12-2018

Answering your questions: How the TGA regulates medical devices in Australia

Answering your questions: How the TGA regulates medical devices in Australia

An overview of medical devices regulation in Australia

Therapeutic Goods Administration - Australia

21-12-2018

Medical devices overview

Medical devices overview

Overview of medical devices regulation

Therapeutic Goods Administration - Australia

20-12-2018

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here:  https://go.usa.gov/

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/

. @US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/xEaNB  #MedicalDevice

FDA - U.S. Food and Drug Administration

19-12-2018

Consultation: Medical device cyber security

Consultation: Medical device cyber security

The TGA is seeking comments from interested parties on the applicability and usefulness of the content contained in the draft regulatory guidance and information materials. Closing date: 14 February 2019

Therapeutic Goods Administration - Australia