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Medical Devices Recordkeeping Requirements

King & Spalding

EU Artificial Intelligence Regulation Published - What You Need to Know

King & Spalding on

Friday, July 12, 2024, the EU published the new EU Artificial Intelligence Regulation, which is first EU AI Regulation worldwide setting requirements concerning safety and free movement of goods and services using AI...more

McDermott Will & Emery

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, 2022. While FDA generally...more

BakerHostetler

FDA and Pharmacy Weekly Digest - October 2020 #1

BakerHostetler on

FDA Released Food Traceability Proposed Rule – The United States Food and Drug Administration (FDA) is proposing to establish additional traceability recordkeeping requirements for manufacturers, processors, packers or...more

Stinson LLP

FDA Eases Medical Evaluation and Recordkeeping Requirements for Hearing Aids

Stinson LLP on

On Wednesday, the Food and Drug Administration (FDA) released a new guidance document indicating that it will not enforce the medical evaluation and recordkeeping requirements (21 CFR §801.421(a) and (d)) prior to the...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

OSHA: Kinesiology Tape is “Medical Treatment” for Recordkeeping Purposes

You have probably seen kinesiology tape, also known as KT Tape or Kinesio Tape: those bright, neon-colored tape strips worn by runners, cyclists, athletes, triathletes, and folks at the gym. In a December 12 letter of...more

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