CDRH Posts

Extending Quality Management Beyond the Four Walls of Your Quality Organization

Extending Quality Management Beyond the Four Walls of Your Quality Organization

Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions

Let’s face it, the arms of regulators are getting longer and so is their vision. The extended supply chain is experiencing additional oversight by regulatory bodies around the world, and in fact, your suppliers’ suppliers are not immune to that scrutiny. The list of organizational quality stakeholders continues to grow as the value chain expands to include suppliers and even regulators themselves.

This means that a Quality Management System (QMS) needs to be enterprise strong and it needs to be global if an organization is to respond to harmonization of standards, guidelines, and regulations around the world regarding the organization’s value chain.
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Electronic MedWatch Reporting: eMDR Testing with CDRH (Free E-Book)

Electronic MedWatch Reporting: eMDR Testing with CDRH (Free E-Book)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

A few months back, we hosted a webinar on the eMDR Countdown to Compliance during which we learned that from beginning to end, the transition to electronic medical device report submissions (electronic MedWatch or FDA Form 3500A reporting) can take between four to six months. But how do you really know that you’re ready to comply with the new mandate?

Today, let’s point the microscope at one piece of the puzzle: testing your electronic medical device report submissions with the FDA’s CDRH. Testing gives you the opportunity to identify and correct trouble areas before you transition to production electronic reporting. (more…)

electronic Medical Device Reports: 3 Reasons Med Device Manufacturers Should Go Electronic Now

electronic Medical Device Reports: 3 Reasons Med Device Manufacturers Should Go Electronic Now

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

We’ve already covered the impact of recent eMDR regulation updates on the industry (the overall benefits for patients and the health care community as a whole) in a previous post. Now let’s take a closer look at why medical device manufacturers may not want to delay their transition to electronic medical device reporting. (more…)

The ACK Facts: Truths About eMDR Acknowledgement Files

The ACK Facts: Truths About eMDR Acknowledgement Files

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

When it comes to adverse event reporting and eMDR, understanding how things work plays a role in your organization’s success. This is especially true with acknowledgement files (ACKs), as they determine whether you have met your regulatory reporting requirements. (more…)

FDA Final Ruling on electronic MedWatch reports: The Impact on the Industry

FDA Final Ruling on electronic MedWatch reports: The Impact on the Industry

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Have you heard the big news? All mandatory 3500A MedWatch reports submitted by medical device manufacturers and importers must be now submitted electronically. On February 14, 2014, the FDA released its final decision on electronic Medical Device Reporting (eMDR). By August 14, 2015, all medical device manufacturers and importers will be required to submit mandatory 3500A MedWatch reports electronically to the FDA’s Center for Device and Radiological Health (CDRH). We’ve been waiting for this final decision since 2009 when the rule was proposed and opened for public comment. (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 tells Drug Makers, “Just the Facts, Ma’am”

Beginning in March 2011, companies testing experimental drugs or medical products will be required to inform the FDA within 15 days about serious risks and adverse reactions that arise during clinical studies (FDA, Sept. 2010). This isn’t anything new … the FDA just wants to make it simpler. The final rule is a revision of a proposed rule that was issued in March 2003. Apparently, many companies were piling information on the FDA in droves, making it harder for the agency to sift through the data quagmire to find the necessary information. Wanna make it easier on yourself and the FDA? Think Electronic Regulatory Reporting.
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