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Food, Drug and Cosmetic Act (FDCA)

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FDA, Life Sciences Industry, Medical Device, Food, Drug and Cosmetic Act (FDCA)

FDA’s Posts Final Guidance for Remanufacturing

May 14, 2024

The FDA has issued a final guidance for servicing and remanufacturing services for medical devices, which will end the agency’s enforcement discretion for remanufacturing activities. Manufacturers...

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FDA, Lab Developed Tests, Life Sciences Industry, Medical Device, Food, Drug and Cosmetic Act (FDCA)

FDA Proposes End to Enforcement Discretion for Lab-Developed Tests

October 09, 2023

The FDA has released a draft rule for regulation of lab-developed tests (LDTs) that would terminate the existing policy of enforcement discretion over a period of approximately four years. The...

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Medmarc is a proud member of TDC Specialty. TDC Specialty is the marketing name for the specialty insurance operations and services of The Doctors Company and its subsidiaries and affiliated companies, including TDC Specialty Underwriters, Inc., TDC Specialty Insurance Company, TDC National Assurance Company, Healthcare Risk Advisors, Inc., Hospitals Insurance Company, Inc., ProAssurance Specialty Insurance Company, NORCAL Specialty Insurance Company, and Medmarc Casualty Insurance Company. All products and services are written or provided by subsidiaries or affiliates of The Doctors Company. The Doctors Company does not underwrite excess and surplus lines insurance. Certain coverages may be provided through surplus lines insurance subsidiaries of The Doctors Company through licensed surplus lines brokers. Coverages may be underwritten by TDC Specialty Insurance Company, TDC National Assurance Company, Hospitals Insurance Company, Inc., ProAssurance Specialty Insurance Company, NORCAL Specialty Insurance Company, or Medmarc Casualty Insurance Company. Product summaries are for informational purposes only. Coverage is subject to the language of the policy as actually issued. Coverage, policy terms, and availability may vary by state.

TDC Specialty Underwriters, Inc., is based and domiciled in Connecticut; in California d/b/a Insurance City Solutions (license #0L85833) and in New York, d/b/a TDC Specialty Underwriters Services. Healthcare Risk Advisors, Inc., is based and domiciled in New York.