4 Questions to Ask Before Submitting a 510(k)

November 12, 2020 / by Kapstone Medical / 2 minute read

So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA regulates medical devices, but that’s about as far as your knowledge takes you.

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EU MDR and Post Market Surveillance: What You Need to Know

January 8, 2020 / by Kapstone Medical / 5 minute read

Part 6 in a 7-part series on the EU’s Medical Device Regulation

The new EU Medical Device Regulation (MDR) builds on the framework of the MDD with an increased emphasis on post-market surveillance (PMS) and post-market clinical follow-up (PMCF), similar to FDA’s approach for high risk devices.

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FDA Approves First Continuous Glucose Monitoring System Not Requiring Blood Sample Calibration

December 26, 2018 / by Kapstone Medical / 1 minute read

The FDA approved last July the first continuous glucose monitoring system that could free millions of people with diabetes from daily finger sticks.

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FDA's ASCA Pilot Program

December 20, 2018 / by Kapstone Medical / 1 minute read

Agency publishes details for conformity assessment

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published additional information on its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment, or ASCA.

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FDA lists proposed guidance publications for 2019

October 30, 2018 / by Kapstone Medical / 1 minute read

The FDA issued its list of proposed guidance publications for 2019 on Oct. 5 as part of its agreement to speed approvals of medical devices in exchange for additional funding from industry.

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What You Missed Last Month September

October 29, 2018 / by Kapstone Medical / 1 minute read

September was a busy month for the 3D printing industry. There has been new insight on additive manufacturing and how to handle the latest Medical Device Regulation, a woman’s collapsed ankle was restored with a 3D printed ankle implant, and a new report shows that the medical additive manufacturing field will see significant growth in the coming years. Here is a quick look at what you missed last month:

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Emerging AI Applications in Medical Devices

October 23, 2018 / by Kapstone Medical / 3 minute read

In April, the U.S. FDA issued its first marketing permit for a medical device using artificial intelligence to detect greater than mild diabetic retinopathy. While it was the first such AI approval, it promises to be just the beginning of AI medical devices.

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Shared responsibility for cybersecurity of medical devices widely recognized

October 22, 2018 / by Kapstone Medical / 2 minute read

The FDA issued a warning about vulnerabilities of medical devices to cybersecurity threats in a press release on Oct. 1, 2018 and is taking steps to help organizations improve cybersecurity of their medical devices.

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Playbook sets framework for dealing with medical device cybersecurity attacks

October 18, 2018 / by Kapstone Medical / 2 minute read

Citing the increasing number of cyber attacks in healthcare and concern about the potential for targeting medical devices, the FDA announced in an October 1, 2018 press release the publication of its Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook.

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What You Need to Know about FDA’s Draft Guidance on Writing Test Reports

September 24, 2018 / by Kapstone Medical / 2 minute read

The FDA issued updated draft guidance for submission of test reports and non-clinical bench test performance in premarket submissions in May 2018. As a draft guidance, the FDA is seeking comment from the industry prior to finalization.

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What You Missed Last Month July Edition

August 29, 2018 / by Kapstone Medical / 1 minute read

Lots has happened in the MedTech Industry since last month. New EU Medical Device Regulations continue to pose as a threat to additive manufacturing, the FDA is urging companies to go paperless, and there has been a recent development in 3D printing that will allow biological tissues to be created. Here is a short overview of what you missed in the month of July:

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FDA’s Strategic Policy Roadmap for 2018

April 25, 2018 / by Kapstone Medical / 2 minute read

FDA Commissioner aims to streamline review and beef up technical support

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