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FDA Announces Updates to “Refuse to Accept Policy”

7 questions to ask before submitting 501(k)

The FDA recently issued updates to its guidance for its “Refuse to Accept Policy for 510(k)s” for Center for Biologics Evaluation and Research-regulated...

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FDA Reconfirms Continued Acceptance of Single Audits

In an update to its review of the International Medical Device Regulators Forum report the FDA in December reconfirmed that it will continue to accept results of the Medical Device Single Audit...

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How Useful Are Pre-sub Meetings With the FDA?

Making the most of your Q-submissions

How important is the FDA Pre-sub meeting? If saving time and money is important, then taking advantage of the FDA Pre-submission meeting program is key.

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What You Missed Last Month November Edition (3D Printing)

November proved to be a busy month in the MedTech Industry. From a custom 3D printed shoulder implant helping a patient overcome the wounds of a shooting tragedy to the world’s first jaw...

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What You Missed Last Month October Edition (3D Printing)

Another busy month has passed in the MedTech Industry; especially with 3D printing. From using custom 3D printed valve models for heart surgery to the FDA presenting its case for regulating 3D...
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FDA Seeks Feedback on Draft Guidelines For 3D Printing Medical Devices

FDA committed to fostering innovation in additive manufacturing.

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FDA Sets Priorities for 2016: What Does It Mean for Medical Devices?

It’s the year of Big Data, and FDA has slated several priorities for fiscal year 2016 to improve regulatory science and introduce revised data quality standards. From leveraging Big Data for...

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What You Missed Last Month (October 2015 – Medical Devices & 3D Printing)

Happy November! Fall is finally here, and with the cascading leaves also descends a plethora of exciting developments emanating from the world of Medical Devices and 3D Printing!

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What You Missed Last Month (August 2015 Edition –Medical Device & 3D Printing)

It’s back to school with Team Kapstone! In August, we picked up educational and inspirational stories in 3D printing, medical device, and orthopedics. Here’s your August “What You Missed” reading...

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What You Missed Last Month (July 2015 Edition –Medical Device & 3D Printing)

While you were enjoying your summer vacation, Team Kapstone compiled some of the best stories in 3D printing, medical devices, and orthopedics. Catch back up with three articles to Inspire, Equip,...

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