FDA Posts

FDA Struggles with Rising Imports

Mark Crawford

It’s been a long time coming—overwhelmed by an ever-increasing flood of imported products that need be inspected, in June the FDA announced a plan to better address monitoring and regulating these goods. And, facing the stark realities of restricted funding, outdated technology, and sometimes less-than-willing global partners, it won’t be easy. (more…)

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


So Now That the Food Safety Bill Has Passed, What’s Next?

On January 5, 2011, the Food Safety Modernization Act was passed into law by President Obama.  The new legislation gives the Food and Drug Administration the power to recall tainted food, quarantine geographical areas and access food producers’ records. According to the FDA, the burden of foodborne illness is considerable.  Every year, 1 out of 6 people in the United States — 48 million people — suffers from foodborne illness, more than a hundred thousand are hospitalized, and thousands die. So what does the new legislation mean to food processing companies and manufacturers now? (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.

The Pharmaceutical Industry Still Struggling with CAPA as Part of Overall Quality Management System

One of the biggest challenges for pharmaceutical companies is to complete investigations and actions in a timely manner. In 2009, ICH Q10 adopted by the FDA as an industry guideline, names pharmaceutical Quality Management Systems as a necessity to detect and evaluate non-conformances and take respective corrective and preventative actions. Although it takes time, an efficient CAPA process is an effective tool that can significantly improve quality systems and processes. (more…)

MHRA Looking for Quality Risk Management Systems — Sound Familiar?

The UK is on to something. British inspectors will be looking for a “risk register” and a defined document management control system including periodic reviews of risk management assessments when inspecting drug manufacturers. It seems both sides of the Atlantic are on board with quality risk management, and for good reason. (more…)

Quality and Safety Systems Need to Break Out of their Shells

The Senate reconvened this month with a very important bill on its plate – the Food Safety Modernization Act (S. 510). With the recall of more than 550 million eggs and over 1,500 people sickened from salmonella fresh on their minds, this bill couldn’t be served up at a better time. Many of the backers of this bill feel strongly that this could have prevented or at least minimized the outbreak, and are hopeful that it will “solve” all potential future outbreaks. However, the 483 violations found at the two facilities were mostly facility-focused and clear violations of the Salmonella Prevention Plan. While the FDA has focused on the state of the facility’s environment, where is the focus on the quality and safety systems that are supposed to be in place at the company to prevent it from becoming a national crisis? As food safety issues continue to grow, regardless of whether S.510 is passed or not, manufacturers need to take control of their quality and safety issues in-house to prevent such disasters.  (more…)

eMDR to Become Mandatory – Ready, Aim… WAIT!

eMDR to Become Mandatory – Ready, Aim… WAIT!

The FDA’s Center for Device and Radiological Health (CDRH)  has had a focused project team engaged in developing, educating, communicating and assisting medical device companies on how to submit Adverse Event reports (MedWatch 3500A) in an electronic format, now known as eMDR (electronic Medical Device Report). In 2005, Indira Konduri, eMDR Project Manager, solicited help from industry to move forward on the testing and confirmation of the eMDR requirements.  The solution leveraged the Health Level 7 standards (HL7) and the outcome was an Individual Case Safety Record (ICSR version 1).  Kudos to the eMDR team during this period when the FDA showed an incredible ability to “listen” to the voice of industry and displayed a willingness to engage in joint discussions on the best way to handle issues. (more…)

The FDA Devotes Almost Half of its Staff to Product Regulation – Shouldn’t They Eat Their Own Dog Food?

Compliance and Quality management is crucial issue for almost any business, large or small. No matter what medical product your company manufactures or services, it’s a virtual certainty that you are beholden to an array of different regulations, both internal and from the FDA such as cGMP quality systems. Ensuring that your company remains in compliance with these regulations and proving the quality and safety of products and services at all times is something that can’t be left to chance. (more…)