US FDA statement on Evaluation of Materials in Medical Devices


The US FDA released a statement on the topic of materials used in medical devices as part of their effort to address potential safety questions.

Based on US FDA's evaluation and discussions with relevant experts and academia, some evidence suggests that a handful of individuals may be prone to developing an immune/inflammatory reaction when exposed to select materials.

Medical devices and their related materials mentioned in the statement includes:

  • Breast implants - silicone

  • Cardiovascular stents and guide wires - nitinol (a nickel and titanium alloy)

US FDA also mentioned concerns of animal materials used in medical devices such as additives used on device coatings and heart valves made from pig tissue. US FDA released a guidance on 15 March 2019 to provide recommendations to device manufacturers in effort to minimise the potential risk of transmitting diseases from animals to humans:

-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Guidance Document

For more information on the statement, check out the following link:

-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

Contact us at info@arqon.com.


54 views

Recent Posts

See All

North America - Nov/Dec 2019

USA: FDA medical device user fees for fiscal year 2020 increase by almost 6% USA: Comments sought on possible exemption of powered wheelchair stretchers from pre-market notification USA: Guidance docu

North America - Aug 2019

Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting requirements for hospitals Canada: Post-market surveillance requirem

Drugs - Aug 2019

China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of Alignment in Marketing Application Decisions Between EU and US. S

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle
  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle

Services

Contacts

Call us:

   : +65 6909 0396

   : +65 9067 1432

 

Email us: info@arqon.com

Resources

© 2020 ARQon All Rights Reserved. 

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle