News | September 24, 2012

Top 10 Changes to U.S. FDA Medical Device Registrations and Listings

Registrar Corp reports on the top 10 changes the new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes on Medical Device Registrations and Listings.

September 24, 2012—The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective Oct. 1, 2012. To assist the medical device industry, Registrar Corp has provided the following list of top 10 things that medical device professionals need to know regarding FDASIA:

  1. All proprietary names under which a medical device is marketed must be reported, at a minimum, when a medical device is first listed and during the annual update of registration and listing information.
  2. Combination products (i.e. products comprising a medical device and a biological product or a drug) must be identified as a combination product and the type of combination product.
  3. All contract manufacturers and sterilizers of finished medical devices must register and list regardless of whether they put the medical device into commercial distribution or return the medical device to the manufacturer or specification developer.
  4. Initial importers must identify the manufacturers of the medical devices they are importing.
  5. Foreign establishments that are exporting medical devices or offering medical devices for export to the United States must identify all known U.S. importers of their devices.
  6. A device must be listed by the manufacturer, specification developer, single-use medical device reprocessor, remanufacturer or repacker /relabeler before a foreign exporter, contract manufacturer or contract sterilizer can list it.
  7. Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to “Complaint File Establishment.”
  8. Establishments located in foreign trade zones must now register and list, as well as identify themselves as being located in a foreign trade zone.
  9. All establishments that are required to register must now pay the annual registration user fee as required by FDASIA.
  10. To have your medical device registration, renewal and listing submitted to FDA by a Regulatory Specialist, simply contact Registrar Corp at +1-757-224-0177. Registrar Corp’s regulatory specialists are available to assist you as the new requirements take effect on Oct. 1, 2012.

 

For more information: www.registrarcorp.com/livehelp

Related Content

Toshiba Highlights Latest CT Advancements at RSNA 2017
News | Computed Tomography (CT) | September 18, 2017
Toshiba Medical announced that it will display several new enhancements to its existing computed tomography (CT)...
Hitachi Supria True64 CT Receives FDA Clearance
Technology | Computed Tomography (CT) | September 15, 2017
September 15, 2017 — Hitachi Healthcare Americas Inc. announced it has attained U.S.
Matrix Analytics Beginning Validation of Deep Learning Lung CT Tools
News | Lung Cancer | September 13, 2017
Matrix Analytics announced it will clinically validate its LungDirect deep learning and predictive analytics tools for...
Orange County, Calif. Hospital Adopts Siemens Somatom Force CT for Cardiac Imaging
News | Computed Tomography (CT) | September 12, 2017
Hoag Memorial Hospital Presbyterian recently became the first hospital in Orange County, Calif., to install the Siemens...
Patient X-ray radiation exposure from medical imaging has been a hot topic in radiology and has prompted the implementation of radiation dose monitoring systems.
Feature | Radiation Dose Management | September 08, 2017 | By Dave Fornell
Patient X-ray radiation exposure from medical imaging has been a hot topic in radiology and has prompted the...
Technology | Radiation Dose Management | September 07, 2017
September 7, 2017 — Sapheneia and Scannerside received U.S.
20/20 GeneSystems Launches AI-Based Lung Cancer Detection Technology in China
Technology | Lung Cancer | August 28, 2017
20/20 GeneSystems Inc. recently released in China what is believed to be the world’s first machine learning algorithm...
Philips to Develop FFR-CT in Partnership With HeartFlow
News | CT Angiography (CTA) | August 28, 2017
August 28, 2017 — Philips Healthcare and HeartFlow Inc.
St. Cloud Hospital Installs Toshiba Aquilion One Genesis CT for Emergency Department
News | Computed Tomography (CT) | August 23, 2017
Central Minnesota residents now have access to advanced computed tomography (CT) technology that is safe and fast at St...
Overlay Init