Tag Archives: FDA

Devine Guidance

FDA Issues a Warning Letter with no Plant Inspection! What?

By Dr. Christopher Joseph Devine

If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly.

If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

What About the Reports?

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

If you work in the device industry in the United States and introduce FDA approved/cleared product into commerce in the United States, then it is incumbent upon the device establishment to play by FDA’s rules. Remember, if you are playing in FDA’s sandbox, then you must play by FDA’s rules.

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FDA Issues Final Guidance on Reprocessing of Reusable Medical Devices

By MedTech Intelligence Staff

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.

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FDA Unveils Vision for National Post-Market Device Surveillance

By MedTech Intelligence Staff

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.

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Ameing for Asia

Hopes and Hurdles for Medical Device Companies in China in the Year of the Ram

By Ames Gross

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?

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Reprocessing Warning

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

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.

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