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April 2024 Regulatory Compliance Updates

Verisys

– The best resource for monthly healthcare regulatory compliance updates. Compliance Updates: April 2024 Overlook: Licensure Compacts Other Legislation Board Updates Interstate Medical Licensure Compact (IMLCC): On March 21, 2024, Florida joined the IMLCC as the 42nd member jurisdiction via Florida Senate Bill 7016.

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Medical Spa Requirements Florida

Florida Health Care Law Firm

Its growth is expected to almost double by 2028. The law requires that all services be provided by licensed medical professionals who have current certifications in the procedures they are providing. Do You Need a Medical Spa License in Florida? Who Can Own a Medical Spa in Florida? Call now for more information.

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From Discretion to Regulation: What FDA’s Final Rule Means for Laboratory Developed Tests

Hall Render

Stage 5: Effective May 6, 2028 Four years following the publication of the Final Rule, the FDA will enforce premarket review requirements for moderate (Class II) and low-risk (Class I) IVDs (i.e., The FDA notes that it will continue to exercise enforcement discretion during the review of premarket submissions received by this stage.

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Understanding Marketability Acts: Eliminating Encumbrances on Real Property

Hall Render

Easements and Similar Interests : Easements, licenses, rights of way and similar encumbrances grant a third party the right to use a portion of another’s property for a specific purpose. If an easement or similar interest is recorded properly in the public records, it is generally exempt from extinguishment under most Acts.

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Healthcare Reforms Under the IRA: Expanding Access to Care

Healthcare Law Blog

Fifteen more Part D drugs are set to be published in 2027, followed by 15 Part D and Part B drugs, collectively, in 2028. With respect to biological products, however, such drugs must be licensed in accordance with the Public Health Service Act (“PHSA”) for at least 11 years, and marketed in conformance with the PHSA.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. The written procedure for recall was inadequate and this procedure had not been implemented.

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SQA Regulatory Surveillance Summary for May and June 2024

SQA

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

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