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Comment Period FDA Approval Life Sciences

Jones Day

FDA on Board With Continuing Remote Inspections

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The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

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The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

MoFo Life Sciences

QMSR: Welcomed By The Industry, But Lacking In Practicality

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On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments."...more

Hogan Lovells

CMS delays “reasonable and necessary” definition, expedited breakthrough device coverage process rule

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On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more

Polsinelli

CMS Proposes Medicare Coverage Pathway for FDA-Designated Breakthrough Technologies

Polsinelli on

On September 1st, the Centers for Medicare & Medicaid Services (CMS) proposed a rule offering medical device manufacturers Medicare coverage upon FDA clearance or approval when their products have been designated by the U.S....more

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