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Enforcement & Litigation

Set Alert for Enforcement and Legislation

FDA Unveils 3-Phase Approach For Bringing Products Back Under Compliance After Pandemic Enforcement Leeway

The US FDA says in a new draft guidance document that makers of a variety of devices and diagnostics that were given wide enforcement berth by the agency to use their products to respond to COVID-19 must eventually transition back to full regulatory compliance under a proposed three-phase plan.

Enforcement Compliance Guidance Documents

Senators, State AGs Differ On Whether Further Federal Regulation Needed For OTC Hearing Aids

Sens. Warren and Grassley say federal regulation is needed to ensure consumers in all states benefit from OTC hearing aids. State AGs, on the other hand, have asked the FDA to “define preemption terms in a way that recognizes the important role state and local entities play in protecting consumers.”

Policy Durable Medical Equipment

Philips Trilogy Evo Ventilators, Repair Kits Recalled Because Supplier Used Nonconforming Foam

Specific Trilogy Evo ventilators and their repair kits have been recalled because a Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) foam, a nonconforming material, in the manufacture of their muffler assembly. The US FDA gave the recall a high-risk designation on 26 January.

Recalls Safety

QUOTED. Sen. Patty Murray.

Sen. Patty Murray said she doesn’t want more uncertainty about user fees during the COVID-19 pandemic and will move to get all the user fees renewed before they expire in September. See what Sen. Murray told Medtech Insight about it here.

Quoted User Fees

Top Senator ‘Disappointed’ With Missing MDUFA Package

Sen. Patty Murray said she doesn’t want more uncertainty about user fees during the COVID-19 pandemic and will move to get all the user fees renewed before they expire in September.

Regulation Policy

COVID-19 Delays CMS Final CLIA Rule On Analyte Proficiency Testing

The CMS says due the pandemic it won’t be able to meet a February deadline to finalize a rule for proficiency testing of analytes used by CLIA laboratories. The deadline has been moved forward a year.

Regulation Policy

FDA Extends On-Site Surveillance Inspections Freeze Another 2 Weeks Because Of Omicron

The US agency had previously decided to halt domestic inspections through at least 19 January because of the COVID-19 Omicron variant. But now that timeline has been lengthened.

FDA Compliance

Medtronic’s Second Class I Recall This Year Is For HawkOne System

The US FDA on 21 January gave its highest risk designation to a recall of Medtronic’s HawkOne Directional Atherectomy System. The recall comes on the heels of another class I for the company’s cranial software.

Recalls Safety

Speaking Of Medtech, Ep. 6: 2022 Predictions For FDA’s Device Center

In this episode of Speaking Of Medtech we’re breaking out the crystal ball to give a few predictions of what could be in store this year for industry and the US FDA’s Center for Devices and Radiological Health. From the ongoing COVID-19 pandemic to digital devices and facility inspections, there’s a lot of ground to cover.

Speaking of Medtech FDA
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