Signal Medical Warning Letter

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MicroSeal Hip System Problems Result in Warning Letter to …

https://www.aboutlawsuits.com/microseal-hip-warning-letter-82570/

Signal Medical has received an FDA warning letter for altering the design of its Microseal hip replacement system without FDA approval. Skip to main content …

FDA warns Signal Medical on unapproved …

https://orthostreams.com/2015/05/fda-warns-signal-medical-on-unapproved-hip-implants/

The FDA sends a warning letter to Signal Medical, flagging it for making unapproved changes to its MicroSeal hip implants. The FDA flagged Signal Medical …

CDRH Transparency: Compliance & Enforcement | FDA

https://www.fda.gov/about-fda/cdrh-transparency/cdrh-transparency-compliance-enforcement

When a medical device manufacturer fails to comply with these requirements, the FDA responds with tools that include warning letters and recalls. In most cases, a company …

October - December 2020 | Potential Signals of Serious …

https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/october-december-2020-potential-signals-serious-risksnew-safety-information-identified-fda-adverse

Aug 11, 2021

Medical Devices Warning Letters | StarFish …

https://starfishmedical.com/blog/medical-devices-fda-warning-letters/

Medical Devices FDA Warning Letters. If you are in the medical device industry, either as an …

FDA Warning Letters Signal Narrowing of “Medical Food” …

https://www.morganlewis.com/pubs/2014/02/foodindustry_lf_fdawarninglettersmedicalfoodcategory_14feb14

On December 26, 2013, shortly after the close of the comment period for the Draft Medical Food FAQ, the FDA issued two Warning Letters to medical food …

FDA’s document-based inspections prompt …

https://www.raps.org/news-and-articles/news-articles/2021/4/fdas-document-based-inspections-prompt-warning-let

Regulatory News | 13 April 2021 | By Joanne S. Eglovitch. The US Food and Drug Administration (FDA) on 13 April warned South American active pharmaceutical …

Top 10 Reasons for FDA Warning Letters to Medical …

https://www.medtechintelligence.com/feature_article/top-10-reasons-for-fda-warning-letters-to-medical-device-firms/

The following were the Top 10 observations noted in those letters: 21 CFR 803.17 – Failure to develop, maintain, and implement written Medical Device Reporting …

Violations Found in Medical Device Warning Letters

https://www.natlawreview.com/article/unpacking-averages-violations-found-medical-device-warning-letters

The first trick is to make sure that we have all the device warning letters. It’s not as simple as taking all the warning letters issued by the Center for Devices and …

Food and Drug Administration (FDA) Warning Letters …

https://www.natlawreview.com/article/food-and-drug-administration-fda-warning-letters-signal-narrowing-medical-food-categ

The products identified in these Warning Letters were intended to manage a wide variety of patient conditions, including neuropathy, cardiovascular disease, …

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