2018, Consulting, Electronics and Specialization

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2018

Consulting

Electronics

Specialization

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law

NOVEMBER 20, 2024

of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18. It is recommended to submit a Pre-Submission to the Agency when considering your chemical characterization strategy, especially for any devices/materials with special considerations or use of alternative strategies and solvents.

Provider

Provider Medical Manufacturing Consulting

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law

JUNE 10, 2025

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.

Specialization

Specialization Manufacturing Electronics PCP

Primary Care Digest

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

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