FDA Posts

Go to the Head of the Class: 3 Ways Employee Training Puts Quality Front & Center

Go to the Head of the Class: 3 Ways Employee Training Puts Quality Front & Center

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

There’s a popular saying: ‘You don’t know what you don’t know.’ No kidding. But nowhere is this truer than in the regulated workplace. When employees aren’t trained, they run the risk of adversely impacting its quality, its compliance, its reputation, even its profits.

That’s why employee training is an essential component of a comprehensive quality management system. In fact, you’re likely to find well-trained employees at the foundation of any successful organization that manufactures safe, dependable, quality products. (more…)

Unannounced Regulatory Audits Hitting Global Med Device Community

Unannounced Regulatory Audits Hitting Global Med Device Community

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

No one likes to be caught off-guard. Have you ever had a contractor show up at your home before you’ve even woken up? Or your child tells you he needs his original birth certificate the very next morning to register for camp. These facts of life often arise when you least expect it. (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’s New RTA Policy Is Just What Some Companies Need

FDA’s New RTA Policy Is Just What Some Companies Need

Mark Crawford

The FDA’s updated Refuse to Accept (RTA) policy for 510(k) applications that lack required documentation is now in effect.  The draft version was issued last summer.

This new policy outlines an early review process for 510(k) applications to determine whether they contain all the required materials for starting a substantive review. (more…)

FDA Seeks More Control over Drug Compounders

FDA Seeks More Control over Drug Compounders

Mark Crawford

Meningitis gets attention.

As a result of the national outbreak linked to a Massachusetts compounding pharmacy that has so far killed 32 people and sickened about 500 others, the FDA has petitioned Congress for more authority over compounding facilities. (more…)

Five Years, Twenty-Six Days

Five Years, Twenty-Six Days

Mark Crawford

On October 15, the FDA published guidance regarding new efforts to reduce the average total wait time for 510(k) decisions from an average of 150 days in FY 2012 to 124 days in FY 2017. They will seek to do this by hiring more reviewers and investing more resources, both made possible by the Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. (more…)

Social Media Can Be a Dangerous Tool

Social Media Can Be a Dangerous Tool

Mark Crawford

It’s not too hard to slip up with social media and get the unwanted attention of the FDA, which is getting serious about policing off-label promotion of products.

With companies scrambling to utilize social media (often without dedicated management), and the confusion that exists about what companies can do legally with off-label promotion, mistakes are going to happen. (more…)

Clinical Trials Guidance: Q&A with Patrick Stone

Mark Crawford

Patrick Stone is president and lead consultant for TradeStone QA LLC in Austin, Texas (www.tradestoneqa.com). A strong advocate for human subject protection, his specialties include bioresearch monitoring in human clinical and pre-clinical trials. The following interview focuses on the FDA and clinical trials. (more…)

FDA Seeks to Standardize Electronic Data Submittals

Mark Crawford

In February the FDA released a guidance document proposing a standardized format for submitting clinical and nonclinical data to the agency. The FDA maintains that by following this protocol early in the product development cycle medical device and pharmaceutical companies can reduce bottlenecks and speed up the approval process. (more…)