Alert

FDA Final Order: Metal-on-Metal Hip Implant Manufacturers Must File PMA

By MedTech Intelligence Staff

…semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component. “FDA believes that there is insufficient evidence and information to conclude that general…

…semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component. “FDA believes that there is insufficient evidence and information to conclude that general…

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

Failure to Calibrate Equipment, Seriously?

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 9, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. LAR MFG., LLC….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 9, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. LAR MFG., LLC….

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Jon Speer, Greenlight.guru

Risk: Look at the Big Picture

By Maria Fontanazza

Establishing risk acceptability is a fundamental yet complex part of risk management, throughout the product lifecycle. With a variety of factors involved in the process, medical device companies face the…

Establishing risk acceptability is a fundamental yet complex part of risk management, throughout the product lifecycle. With a variety of factors involved in the process, medical device companies face the…

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ECRI Instiute

Testing Devices Critical Part of Improving Patient Safety

By Maria Fontanazza

…a myriad of services to the broader healthcare industry, from healthcare facilities to nurses and physicians to medical device companies (which ECRI calls “suppliers”). With the objective of improving patient…

…a myriad of services to the broader healthcare industry, from healthcare facilities to nurses and physicians to medical device companies (which ECRI calls “suppliers”). With the objective of improving patient…

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David Amor, Medgineering
Soapbox

Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing

By David Amor

…of a company’s regulatory approach. There is an example I recall when a venture group called me after a product’s 510(k) was refused for several reasons. I immediately recognized the…

…of a company’s regulatory approach. There is an example I recall when a venture group called me after a product’s 510(k) was refused for several reasons. I immediately recognized the…

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Dollar, money

Combination Products to Get Part of $5.1 Billion Requested FDA Budget

By MedTech Intelligence Staff

…center will accelerate the development of new combination products, along with supporting development of companion diagnostic tests and using combination products to treat cancer. FDA also wants more than $3…

…center will accelerate the development of new combination products, along with supporting development of companion diagnostic tests and using combination products to treat cancer. FDA also wants more than $3…

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ECRI, duodenoscopes, endoscopes

Why Duodenoscopes Are So Tough to Clean

By Maria Fontanazza

…get the cleaning done—and how fast. During a recent visit to ECRI (Plymouth Meeting, PA), Lavanchy explained the complex design of the devices and why they can be so difficult…

…get the cleaning done—and how fast. During a recent visit to ECRI (Plymouth Meeting, PA), Lavanchy explained the complex design of the devices and why they can be so difficult…

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

Significant Design Change Requires FDA Notification

By Dr. Christopher Joseph Devine

…because you introduced or delivered into interstate commerce for commercial distribution a device with major changes/modification to the intended use without submitting a new premarket notification to the agency, as…

…because you introduced or delivered into interstate commerce for commercial distribution a device with major changes/modification to the intended use without submitting a new premarket notification to the agency, as…

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Ed Dougherty, Dentons

Developing an mHealth Technology? Answer These Questions First

By Maria Fontanazza

…navigate the market. During an interactive session, Ed Dougherty, principal in Dentons’ global healthcare practice, asked attendees what questions companies should make sure they answer, especially those “starry-eyed” entrepreneurs, as…

…navigate the market. During an interactive session, Ed Dougherty, principal in Dentons’ global healthcare practice, asked attendees what questions companies should make sure they answer, especially those “starry-eyed” entrepreneurs, as…

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Human Factors, Combination Products Focus of Latest FDA Guidances

By MedTech Intelligence Staff

…states. The draft guidance is open for comments until May 3, 2016. The agency addressed human factors in combination products in a draft guidance released last week. Human Factors Studies…

…states. The draft guidance is open for comments until May 3, 2016. The agency addressed human factors in combination products in a draft guidance released last week. Human Factors Studies…

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