Cook Medical Recalls More than 4 Million Catheters

By MedTech Intelligence Staff

…of the catheter tip, which results in tip fraction and/or separation. This problem has resulted in 30 Medical Device Reports (MDR) thus far. Catheter polymer degradation can cause adverse events…

…of the catheter tip, which results in tip fraction and/or separation. This problem has resulted in 30 Medical Device Reports (MDR) thus far. Catheter polymer degradation can cause adverse events…

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

How Can an Establishment Manufacture Medical Devices Without a DMR?

By Dr. Christopher Joseph Devine

MDR is nothing more than the recipe needed to manufacture finished medical devices that are safe and effective in their intended use. Two: Having a MDR is not optional. Three:…

MDR is nothing more than the recipe needed to manufacture finished medical devices that are safe and effective in their intended use. Two: Having a MDR is not optional. Three:…

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FDA

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

By MedTech Intelligence Staff

…Testing (Biocompatibility) Postmarket Surveillance Studies Under Section 522 of the Food, Drug, and Cosmetic Act Medical Device Reporting (MDR) for Manufacturers A-List Draft Guidance Medical Device Decision Support Software Use…

…Testing (Biocompatibility) Postmarket Surveillance Studies Under Section 522 of the Food, Drug, and Cosmetic Act Medical Device Reporting (MDR) for Manufacturers A-List Draft Guidance Medical Device Decision Support Software Use…

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

Detention Never a Good Thing, Even for Medical Devices

By Dr. Christopher Joseph Devine

…that Part 803 (Medical Device Reporting) has been through some minor agency tweaks over the past two years, such as UDI and eMDR requirements. Please keep in mind, when changes…

…that Part 803 (Medical Device Reporting) has been through some minor agency tweaks over the past two years, such as UDI and eMDR requirements. Please keep in mind, when changes…

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

eMDRs Part Deux: FDA on a Mission

By Dr. Christopher Joseph Devine

…519 of the Act; (c) failed to adequately develop, maintain and implement written MDR procedures as required by 21 CFR 803.17; (d) filed what appears to be late MDRs; and…

…519 of the Act; (c) failed to adequately develop, maintain and implement written MDR procedures as required by 21 CFR 803.17; (d) filed what appears to be late MDRs; and…

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

eMDRs: Fix Your SOPs Now

By Dr. Christopher Joseph Devine

…your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008). The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to…

…your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008). The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to…

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

Endoscopes, Too Little and Too Late

By Dr. Christopher Joseph Devine

…abscesses, after undergoing an endoscopic procedure with your firm’s devices. Your firm submitted one MDR (MDR #8010047-2015-00218) to account for all the patients involved in the event. Your firm failed…

…abscesses, after undergoing an endoscopic procedure with your firm’s devices. Your firm submitted one MDR (MDR #8010047-2015-00218) to account for all the patients involved in the event. Your firm failed…

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

Only Two Form 483 Observations Can Equate to a Warning Letter

By Dr. Christopher Joseph Devine

…organization’s MDR procedure. Please note, as of last week (August 14, 2015) the use of eMDR reporting formally went into effect. Dr. D strongly suggests becoming familiar with the FDA’s…

…organization’s MDR procedure. Please note, as of last week (August 14, 2015) the use of eMDR reporting formally went into effect. Dr. D strongly suggests becoming familiar with the FDA’s…

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

Decorative Contact Lens are Medical Devices, Say What?

By Dr. Christopher Joseph Devine

…include, but are not limited to, the following: Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.” Quality, Purity, Strength “The inspection revealed that…

…include, but are not limited to, the following: Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.” Quality, Purity, Strength “The inspection revealed that…

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Device Meet Drug: Integrating Combination Products Into Your Portfolio

By Anna Julia Hummel, Dr. Tido Eger

…Administration, Department of Health and Human Services, Subchapter H – Medical Devices. European Medical Device Regulations (MDR). Revisions of Medical Device Directives. Accessed May 12, 2015. Retrieved from: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm. Federal…

…Administration, Department of Health and Human Services, Subchapter H – Medical Devices. European Medical Device Regulations (MDR). Revisions of Medical Device Directives. Accessed May 12, 2015. Retrieved from: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm. Federal…

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