Michael Causey’s picture

By: Michael Causey

Jon Speer’s picture

By: Jon Speer

When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet FDA requirements for your design controls. The problem, however, is that too often people forget to ask themselves “Why?”

Larry Spears’s picture

By: Larry Spears

If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements, combination product rules, and updated electronic medical device reporting (eMDR) requirements add to the complexity of a quality management system for good manufacturing practices (GMP) requirements.

Kelly Kuchinski’s picture

By: Kelly Kuchinski

Nestlé USA has officially announced its plans to replace the artificial flavors and colors in its chocolate candy products with natural ingredients. This decision will affect more than 250 chocolate bars across 10 brands. The first three modified candy bars—Baby Ruth, Butterfinger, and Crunch—will appear on store shelves by mid-2015.

Michael Causey’s picture

By: Michael Causey

Michael Causey’s picture

By: Michael Causey


s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure. Bad idea. The company may not have recovered very well, either.

Jeff Mazik’s picture

By: Jeff Mazik

If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting.

Gary Minks’s picture

By: Gary Minks

Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be even more time-consuming when individual regulatory authorities require an independent audit of a manufacturer’s quality management system, refusing to accept audit reports from the same facility prepared for submission to a regulatory authority in another jurisdiction.

Tamar June’s picture

By: Tamar June

The landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the Food and Drug Administration (FDA) unveiled four proposed amendments that will likely make a tough law even tougher.

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