Medical Device Posts

Are You Ready for the EU’s New e-Labeling Rules?

Mark Crawford

In June 2011 the European Commission released a draft regulation on e-labeling (http://ec.europa.eu/enterprise/tbt/). The comment period is over and the final version is expected to be adopted on December 14, with activation starting in March 2013. This gives medical device companies about a year to catch up on the details—of which there are many. (more…)

Will the Medical Device Regulatory Improvement Act Be a Game-Changer?

Mark Crawford

Three years ago the FDA enacted tougher measures to reduce the potential conflicts of interest for medical device experts advising the U.S. Food and Drug Administration (FDA).

Claiming that these rules are strangling the timely advance of new medical devices to the market, U.S. Senators Amy Klobuchar (D-Minnesota), Richard Burr (R-North Carolina), and Michael Bennet (D-Colorado) have introduced the “Medical Device Regulatory Improvement Act” in an effort to streamline the FDA regulatory process. (more…)

Beware: Annex 11 Has Implications for Medical Devices

Beware: Annex 11 Has Implications for Medical Devices

Mark Crawford

In January 2011 the European Medicine Evaluation Agency (EMEA) released an updated version of the European Union’s GMP Annex 11 for computerized systems (Annex 11), as well as an expanded version of Chapter 4 on document management.

These are significant changes for the pharmaceutical industry—the new Annex 11, for example, is about four times larger than the older version. EMEA decided to overhaul Annex 11 to keep up with the increased use of computerized systems in all aspects of good manufacturing practice (GMP), as well as their increased complexity. Annex 11 now addresses the regulatory needs of modern IT systems and imparts extensive requirements for compliance at all levels—for example, it dictates how computer printouts of critical records must indicate if any data has been changed since the original entry. Other key topic areas include business continuity, incident management, electronic signatures, migrating and archiving documents, and more comprehensive security controls. (more…)

Could Your Quality Systems Protect You in a Court of Law?

Mark Crawford

Quality system management and documentation contain a wealth of information (or lack of) that can be used by a regulatory agency like the FDA or a plaintiff in a lawsuit to determine if the company is in compliance with federal regulations or its own internal quality management procedures. Failure to meet these requirements can be highly damaging to a company in litigation.

“Quality manuals and quality system documents are intended to guide the operation of a company’s quality management system, says James Kolka, president of Kolka & Associates in Atlanta and an international legal consultant in regulatory affairs. “Quality system documents are neither intended nor constructed to provide evidence of a company’s concern for patient safety and product safety. If a company wants to prove it cares about patient safety and make safe products, it must build documentation to prove that point.” (more…)

FDA Wants Four-Star Reviews

Mark Crawford

The FDA is tired of being the rate-determining step when it comes to the medical device approval process. In the field of chemistry, the rate-determining step is the slowest step in a chemical reaction—the reaction cannot go faster than the rate-determining step. To speed up their game, the FDA recently announced its medical device reviewers will undergo more extensive training, starting in September 2011.

The medical device review process of the FDA’s Center for Devices and Radiological Health (CDRH) has been heavily criticized over the years for being cumbersome and slow. A major factor in these complaints, especially for 510(k) and Premarket Approval Application (PMA) procedures, is high FDA reviewer turnover. (more…)

FDA Upgrades Human Factors and Usability Expectations

Mark Crawford

Less uncertainty from the FDA, and a smoother 510(k) submission process, is always a good thing. That’s why most medical device manufacturers (MDMs) support the new FDA guidance document released on June 22 that will improve the safety of medical devices by conducting more human factors engineering.

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Impact of the New 510(k)/PMA Process on Companies for Quality Management

The entire medical device community is waiting patiently to see how the U.S. Food and Drug Administration changes the 510(k) clearance process. In January 2011, the Agency announced a plan containing 25 actions it intends to implement during the year to improve the most common path to market for medical devices.

According to a press release, the FDA’s key actions include:

  • Streamlining the “de novo” review process for certain innovative, lower-risk medical devices
  • Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process
  • Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making

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The Increasing Need for Quality Medical Devices is Matched by the Need for Compliance with ISO 13485:2003

In October 2010, Medtronic agreed to pay $268 million to settle U.S. lawsuits and claims related to its Sprint Fidelis family of defibrillation leads recalled three years ago due to faulty wires. In 2009, the company estimated that at least 13 people may have died because of the problem. It’s situations such as this that emphasizes why standards have been put in place, such as ISO 13485: 2003, that help medical device companies maintain quality assurance and manage risk. (more…)