The US Food and Drug Administration (FDA) is required by statute to periodically publish a list of devices that the they have determined to be in short supply. Categories of devices in the device shortage list are:
The full list of devices determined to be in short supply may be reviewed here.
Many years back COCIR, JIRA and MITA collaborated to create a guide for refurbishing medical imaging equipment. After several iterations and versions, the three organizations published in 2015 their guide as Good Refurbishment Practice for Medical Imaging Equipment. In order to widen its availability and to provide the guide with an international cachet, it was issued as an IEC PAS in 2016. An effort to further broaden the appeal and acceptance of the PAS was undertaken by IEC SC62B with the result being conversion of the PAS to a full standard: IEC 63077:2019 Good refurbishment practices for medical equipment.
IEC 63077:2019 describes and defines the process of refurbishment of used medical imaging equipment and applies to the restoration of said imaging equipment to a condition of safety and performance comparable to when the device was new. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This standard describes the actions to be performed using relevant specifications and service procedures to ensure that the refurbishment of medical imaging equipment is done without changing the finished medical imaging equipment’s performance, safety specifications, or intended use according to its original or applicable valid registration.
Devices covered in this standard include: X-ray, CT, MR. Ultrasound, Gamma Cameras, Wholebody Imaging, SPECT, PET and combinations thereof.
This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems.
ASTM International in cooperation with the Centers for Disease Control (CDC) has developed a new mask standard (ASTM F2100-11 Mask Requirements) that covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks used in health care services such as surgery and patient care. ASTM International is providing no-cost public access to this and other important ASTM standards used in the production and testing of personal protective equipment - including face masks, medical gowns, gloves, and hand sanitizers - to support manufacturers, test labs, health care professionals, and the general public as they respond to the global COVID-19 public health emergency.
To access the standards, click HERE, register if you are a new user to the ASTM reading room and then access and download a PDF of the standards relevant to the global health pandemic. You will be asked to login at no cost to you.
The US FDA has issued additional guidance for industry on the expanded use of COVID-19 related medical devices. With the increasing need for these life saving devices, FDA has issued guidance to expand the availability and remote capability of the following devices:
These new FDA policies include:
The US FDA issued this guidance aiming at expanding the availability of clinical electronic thermometers as a screening tool during the Covid-19 pandemic period.
The FDA specifically mentioned that during the emergency period, if a clinical electronic thermometer meets the following two circumstances, the device may be distributed and used:
FDA has issued two new public health emergency enforcement policy documents: One on Gowns, Other Apparel and Gloves and the other on Face Masks and Respirators. The enforcement policy on face masks emphasizes that the FDA is interested in discussing with manufacturers the reprocessing of otherwise disposable N95 and the other particulate filtering respirators to facilitate marketing approval through an emergency use authorization (EUA) for reprocessed devices.
In response to the Coronavirus Disease 2019 (COVID-19) public health emergency,1 FDA’s Center for Devices and Radiological Health (CDRH) has taken the steps described in this letter to prioritize work that advances the nation’s response during this national emergency.2 These steps seek to address the impact of the COVID-19 public health emergency on day-to-day operations in CDRH and in the medical device industry, while ensuring that government and private sector efforts to respond to this national emergency receive the highest priority.
The US FDA is aware that due to Covid-19 outbreak, the supplies of personal protective equipment (PPE) became stressed. The agency recognized the needs raised by healthcare providers especially for surgical masks and surgical and isolation gowns. Therefore FDA may consider expedited review of manufacturing site changes or premarket submissions. Please refer to the attached weblink from FDA for detailed information. Or you may contact marketing@metgoodnyc.com to let us assist you make the submission to FDA.
At the recent 2019 International Medical Device Regulator's Forum (IMDRF) meeting,the following information was presented an update on the Chinese government's agencies:
• Regulation on Medical Device Supervision and Administration (State Council Decree No. 680.)
• UDI System Rules (2019, No. 66)
• UDI pilot program to start with high risk implants (2019.7-2020.7)
• E-RPS submission
+ Notice on Medical Device registration electronic submission implementation (2019 No.46)
+ Based on the RPS ToC guidance of IMDRF WG agreements
+ Start from June/24/2020
+ From Oct/31/2020, paper submission format still acceptable. But the format must be the same as
the electronic submission materials.
• AI guidance
+ The first guidance about AI medical device was developed
+ NMPA set up AI medical device invention cooperation platform including clinical study organization,
IT companies and etc.
• Custom-made medical device
+ NMPA MOH implemented on the Provision on custom-made medical device administration
2019 No. 53 from Jan 1st, 2020.