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Mark Leimbeck, UL
March 1, 2016
Mark Leimbeck, UL

Consistency Needed in Addressing IEC 60601-1 3rd Edition Risk Management

By MedTech Intelligence Staff

There’s a greater emphasis on being able to demonstrate competence in performing required activities.

Continue reading →

Denise Nazario, Stryker
February 24, 2016
Denise Nazario, Stryker
CAPA Corner

Ready, Set, Action: Correction, Preventive or Corrective?

By Denise Nazario Castello

Having a grasp on which actions are necessary at various stages of the CAPA process is critical to a quality program.

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Ed Dougherty, Dentons
February 10, 2016
Ed Dougherty, Dentons

Developing an mHealth Technology? Answer These Questions First

By Maria Fontanazza

Tips from industry peers who are going through the process.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
January 26, 2016
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

More Truths in Advertising

By Dr. Christopher Joseph Devine

FDA simply won’t tolerate extreme claims outside a product’s cleared or approved use.

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FDA
January 18, 2016
FDA

FDA Encouraging Manufacturers to Proactively Prepare for Cybersecurity Vulnerabilities

By MedTech Intelligence Staff

The recently released draft guidance on cybersecurity stresses the importance of preparation versus reaction.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
January 13, 2016
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Receiving Inspection, Who Needs It?

By Dr. Christopher Joseph Devine

There’s no excuse. FDA really does make it easy.

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FDA
December 29, 2015
FDA

CDRH Wants to Publish at Least 12 Final Guidance Documents in 2016

By MedTech Intelligence Staff

From human factors to laboratory developed tests to medical device reporting, CDRH has ambitious plans for 2016.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
December 21, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The Twelve Days of Christmas: Not Exactly!

By Dr. Christopher Joseph Devine

A twist on the classic holiday song, complete with FDA condemnation.

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December 15, 2015
Ameing for Asia

Are Clinical Trials Needed to Register Your Device in China?

In lieu of trials, some companies may be able to submit a CER.

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Alert
November 10, 2015
Alert

Dirty Endoscopes Dethrone Alarms as Biggest Health Tech Hazard

ECRI’s annual list points the finger at poor cleaning of flexible endoscopes.

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Columns

May 14, 2024

FDA Issues Final Guidance on Remanufacturing of Medical Devices

By MedTech Intelligence Staff
FDA Logo

The guidance defines remanufacturing, includes relevant considerations to determine if activities are remanufacturing, and provides recommended labeling information to ensure serviced devices are returned to their established performance and safety specification.

May 1, 2024

FDA Releases Laboratory Developed Tests Final Rule

By MedTech Intelligence Staff
FDA Logo

“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and health care providers can trust.”

April 10, 2024

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines

By MedTech Intelligence Staff
Gavel

The consent decree restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met.

April 3, 2024

FDA to Host Virtual Workshop on ASCA Program Expansion

By MedTech Intelligence Staff
FDA Logo

On April 17, the FDA is hosting a Virtual Public Workshop on approaches to Accreditation Scheme for Conformity Assessment Expansion.

March 25, 2024

FDA Proposes Ban on Electrical Stimulation Devices

By MedTech Intelligence Staff
FDA Logo

“These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.”

March 17, 2024

FDA Outlines its Approach to Artificial Intelligence Regulation

By MedTech Intelligence Staff

“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.

February 20, 2024

FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data

By MedTech Intelligence Staff
FDA Logo

Following a “alarming” increase in medical device submissions containing unreliable data, the FDA is reminding manufacturers and study sponsors that they are responsible for qualifying third-party test labs and closely scrutinizing all testing data.

January 31, 2024

FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office

By MedTech Intelligence Staff
FDA Logo

As part of its reorganization of the CDRH, the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office that will include the Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR) and Office of Equity and Innovative Development (OEID).

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  • MedTech Economics
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