The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.
The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.
How can an establishment refuse to give requested information to FDA or fail to obtain product approval or clearance from the FDA? The winner of this week’s prized FDA Warning Letter “failed or refused” to furnish material or information requested by FDA.
A recent report describes an ambitious national medical device monitoring system that harnesses novel data sources, modern analytical techniques and the participation of all stakeholders to optimize patient care.
A recent report describes an ambitious national medical device monitoring system that harnesses novel data sources, modern analytical techniques and the participation of all stakeholders to optimize patient care.
There are great opportunities for foreign medical device companies in China as the people want better healthcare, the government is increasing access to healthcare, and the market is growing between 15 and 20 percent per year. But access to the marketplace is harder than ever. Why?
There are great opportunities for foreign medical device companies in China as the people want better healthcare, the government is increasing access to healthcare, and the market is growing between 15 and 20 percent per year. But access to the marketplace is harder than ever. Why?
As FDA recommended in its comments to healthcare, it is imperative that providers inform their patients of all risks. However, it is incumbent upon patients to become knowledgeable consumers and ask questions about any procedure they are being exposed to, including the use of instruments that may have been reprocessed.
Mandatory revalidation may not be mandatory when a material change occurs; however, such changes need to be appropriately evaluated. When in doubt, repeat packaging validation. Or, if you believe the scientific evidence/rationale is adequate, then write a robust rationale as to why repeating packaging validation is not required.
The agency has said the new standards are meant to reduce the risk of unintended connections between enteral and non-enteral devices.
The agency has said the new standards are meant to reduce the risk of unintended connections between enteral and non-enteral devices.
If your establishment is entering equipment into commerce that is deemed a finished medical device and product servicing is expected during the normal product life-cycle, then compliance with §820.200 is mandated by the QSR. Mandatory means “not optional” in the eyes of the regulatory gods at FDA.
Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.
Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.
Establishing a quality policy and quality objectives is considered a Quality 101 type of activity. If an establishment is ISO 9001 or ISO 13485 accredited or claiming to be in compliance with 21 CFR, Part 820, then they better have a posted quality policy and meaningful quality objectives.
