Devine Guidance

SCAR – A Favorite Acronym

By Dr. Christopher Joseph Devine

…Reports (MDR’s – another valuable acronym) or even worse a product RECALL, Dr. D’s favorite six-letter word, then 5-working days is not an unreasonable request. The doctor’s best advice is…

…Reports (MDR’s – another valuable acronym) or even worse a product RECALL, Dr. D’s favorite six-letter word, then 5-working days is not an unreasonable request. The doctor’s best advice is…

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

Responding to a Warning Letter

By Dr. Christopher Joseph Devine

…U.S.C. 360i, and 21 CFR 803 – Medical Device Reporting (MDR) regulation. For example, when requested procedures for MDR reportable events were not provided. You should take prompt action to…

…U.S.C. 360i, and 21 CFR 803 – Medical Device Reporting (MDR) regulation. For example, when requested procedures for MDR reportable events were not provided. You should take prompt action to…

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

Complaints (Subsections d and e)

By Dr. Christopher Joseph Devine

…fail to file MDRs. Such stellar performance will be rewarded by a friendly visit from the agency, with a Form 482 in hand (a.k.a., notice of inspection). Warning letter violations…

…fail to file MDRs. Such stellar performance will be rewarded by a friendly visit from the agency, with a Form 482 in hand (a.k.a., notice of inspection). Warning letter violations…

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

Complaints (Subsections a, b, & c)

By Dr. Christopher Joseph Devine

…must file an MDR. Dr. D recommends a complaint file be opened for each complaint received. Confucius says, “It is better to over report than under report MDRs.” In closing,…

…must file an MDR. Dr. D recommends a complaint file be opened for each complaint received. Confucius says, “It is better to over report than under report MDRs.” In closing,…

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

Handling and Storage

By Dr. Christopher Joseph Devine

…Reporting (MDR) process. Receive enough of these forms (a.k.a., MDRs); the device manufacturer can expect a visit from the agency. Warning letter violations The first warning letter observation falls into…

…Reporting (MDR) process. Receive enough of these forms (a.k.a., MDRs); the device manufacturer can expect a visit from the agency. Warning letter violations The first warning letter observation falls into…

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Building the Clinical Risk Perspective into Medical Device Manufacturing

By Thomas Maeder

…oversight rarely appears as a specific observation in FDA warning letters, but is often implied by critiques of MDR reporting or of design controls, notably 820.30(g), requiring that design validation…

…oversight rarely appears as a specific observation in FDA warning letters, but is often implied by critiques of MDR reporting or of design controls, notably 820.30(g), requiring that design validation…

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

Personnel Training

By Dr. Christopher Joseph Devine

…training needs, and company employees who are responsible for medical device manufacturing and complaint, CAPA, and Medical Device Report (MDR) handling are not adequately trained to ensure those duties are…

…training needs, and company employees who are responsible for medical device manufacturing and complaint, CAPA, and Medical Device Report (MDR) handling are not adequately trained to ensure those duties are…

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