Medical Equipment Laws

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Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling and reporting requirements.

FDA's Role in Regulating Medical Devices | FDA

https://www.fda.gov/medical-devices/home-use-devices/fdas-role-regulating-medical-devices

In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must …

Medical Equipment and Devices | Federal Trade …

https://www.ftc.gov/industry/health-care/medical-equipment-devices

Boston Scientific and BTG, In the Matter of. Medical device company Boston Scientific Corp. agreed to divest certain assets to Varian Medical Systems to settle …

For Hospitals and Patients, We Need New Medical Device ‘Right …

https://www.beckershospitalreview.com/strategy/for-hospitals-and-patients-we-need-new-medical-device-right-to-repair-laws.html

The Critical Medical Infrastructure Right-to-Repair Act of 2020, introduced in Congress, is designed to remove barriers to fixing medical equipment during the COVID …

State Regulation of Medical Device Distribution

https://www.morganlewis.com/~/media/files/publication/outside%20publication/article/fdli_medicaldevicedistribution_may-june2009.ashx

medical equipment” or “home medical manufacturers-suppliers, these usually apply only companies that ship directly to patients or end-users (e.g., Florida, Illinois and …

Everything About Florida Law Durable Medical Equipment

https://floridahealthcarelawfirm.com/everything-about-florida-law-durable-medical-equipment/

In Florida, healthcare businesses that violate laws on durable medical equipment face hefty fines and fees on top of legal costs. For example, if you rent or sell …

Laws and Rules - Medical Device Manufacturers and …

https://www.dshs.texas.gov/medical-device-manufacturers-distributors/laws-rules-medical-device-manufacturers-distributors

Texas Administrative Code, Title 25. Sections 229.431 – 229.444, Licensing of Device Distributors and Manufacturers (HTML) Sections 229.431 – 229.444, Licensing of …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.72

The information on this page is current as of Nov 29, 2022. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). …

Justice Department Charges Dozens for $1.2 Billion in …

https://www.justice.gov/opa/pr/justice-department-charges-dozens-12-billion-health-care-fraud

Nationwide Coordinated Law Enforcement Action to Combat Telemedicine, Clinical Laboratory, and Durable Medical Equipment Fraud The Department of Justice …

New Medical ‘Right To Repair’ Legislation …

https://www.forbes.com/sites/sallypipes/2021/05/10/new-right-to-repair-legislation-endangers-california-patients/

Here in California, state lawmakers are currently considering legislation that would severely undermine the quality and safety standards which ensure life-saving medical devices are …

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