FDA to exempt genetic screening systems

FDA is contemplating the exemption of specific genetic screening systems that would test parents for conditions that they may pass down to their children; however, FDA states that not all autosomal recessive carrier screening gene mutation detection systems will be included in the exemption.

According to Zachary Brennan, “FDA may exempt a device if the agency determines that a 510(k) application is not necessary to provide reasonable assurance of the safety and effectiveness of a device.” Currently, the screening is only able to determine carriers of the genes, which have caused false positive results and unnecessary psychological distress.

FDA will make its final decision within the next 120 days. For the FDA report, click here. To find out more, visit the article.

CIMDR discusses ISO 10993 changes

Our Asia Pacific partner, Brandwood Biomedical, authored a fantastic report about last month’s China International Medical Device Regulatory Forum (CIMDR) held in Guangzhou, featuring a workshop on Biological Evaluation of Medical Devices. Twelve senior experts from ISO Technical Committee 194 attended. The workshop pertained to risk management models, importance of chemical characterization, tissue engineering, and multiple aspects of ISO 10993, including blood compatibility testing.

There are varying interpretations of ISO 10993, and different opinions on the extent of testing and specific methods used. Because of these differences, the ISO committee is working hard to establish updated standards and clarification in order to be more consistent globally. The workshop showed a strong indication of a need for changes, and efforts are being made to promote that.

China’s biological evaluation has continued to cause problems with consistency, development and growth, however the workshop displayed engagement and commitment to updating their practices. China is working hard to modernize their practices by aligning them with international standards for device regulation.

To read more about Arthur Brandwood’s opinion on the event, or for more information about the changes to ISO 10993, click here.

Pearl Pathways exhibiting at the IMDMC conference on October 29

On October 29, the Indiana Medical Device Manufacturers Council (IMDMC) is hosting their annual conference. Governor Mike Pence will be attending as the keynote speaker. There is still time to register for a booth or sponsorship. Make sure to stop by Pearl Pathways’ booth. For more event information, click here.

Health Canada now requires labels

Health Canada, a Canadian medical device market regulator, has recently announced that all submissions must include proper labeling for Class II Medical Device Licenses. They have updated their application process to match the change. To read the full article on Mass Device, click here.

Pearl Pathways hires Mary Anne Gfell


Clinical research professional and former Covance Global Project Manager, Mary Anne Gfell, joins Pearl Pathways.

Bringing over 15 years of experience in clinical research and quality compliance, Gfell is a key addition to the Pearl Pathways team. Prior to joining Pearl Pathways, she worked as a Global Project Manager at Covance, a multi-national CRO where she managed central laboratory services for Phase 1 through 4 clinical global studies. Gfell has extensive expertise in both drug and device trials, and started her career in a clinical setting as a Med Tech. She has further expertise in the creation and oversight of quality systems as well as the development of clinical protocols.

Gfell is an active Certified Clinical Research Coordinator (CCRC), a member of the Association for Clinical Research Professionals (ACRP), and holds her project management certification.

To read full press release, click here.

Pearl Pathways announces publishing of new case studies

Pearl Pathways is excited to announce the release of pharma, medical device, and new academic hospital case studies. This brings our total number of case studies to sixteen. Check out our dedicated case study website page here where you can learn through real life examples of how Pearl Pathways has created solutions for our clients. See something that sounds like a problem you are facing? Contact us now for a consultation. To view our case studies, click here.

FDA says yes to 3-D drugs

Recently, the US Food and Drug Administration (FDA) has approved the first 3-D printed drug. This drug was created by a private company located in Pennsylvania and has up to 1,000mg of levetiracetam in it. The reason for this drug is to help those who have trouble swallowing pills. Many children, elderly and others have trouble swallowing pills, but thanks to this new pill they now only need one spill of liquid.

Before 3-D printing drugs was created, 3-D printing was used for medical devices and replicating organs. With the news of 3-D printing, many are hoping to create more drugs for those who have troubles swallowing.

To read more on Fiona Barry’s article in in-Pharma, click here.

What will happen to the medical device tax?

Earlier this month, efforts were made once again to repeal the medical device tax under the Affordable Care Act (ACA). The medical tax is unpopular for both Republicans and Democrats and in June the US House of Representatives passed a bill called Protect Medical Innovation Act in a 280-140 vote. The original tax (created in 2010) would provide a 2.3% tax on the price of a medical device. Many were hoping that this tax would provide the United States with $30 million in revenue.

Although many are hoping to get rid of this tax, the bill will be facing an up hill battle as the White House has announced that it will veto the bill.

To read more on Michael Mezher’s article in RAPS, click here.

Efforts to repeal tax on medical devices making way in Congress

The fight continues. Recent efforts have been made (again!) to repeal the tax on medical device companies, which was a provision in the Affordable Care Act. The revenue from this tax is estimated at about $30 billion in the next ten years. Those in favor of the tax are hoping it will help support the expansion of health coverage throughout the United States. Medical device manufacturers are opposed.

To read more about this ongoing saga, check out Joseph Keenan’s recent article in www.fiercemedicaldevices.com.

120 types of medical devices may be exempted per new FDA Guidance

On June 30th, the US Food and Drug Administration (FDA) announced the intent to exempt 120 medical device classes with the goal to make it easier for companies to market devices. These devices will be exempt from the review requirements and premarket notifications (i.e. 510(k)).

FDA regulation has three classifications for medical devices; low, moderate and high risk. Low risk medical devices have fewer costs and regulatory requirements; therefore manufacturers often desire that their products meet this category.

More details and a list of the 120 types of medical devices can be found in the new FDA guidance released July 1, 2015 entitled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.

FDA should change the regulations to exempt this list of devices from premarket notification ultimately; however, per Alexander Gaffney’s article in www.raps.org, FDA says it won’t “enforce compliance with 510(k) requirements” in the meantime, and will not require companies to submit a 510(k).

To learn more, read Alexander Gaffney’s article on www.raps.org on FDA’s plan, and check out the new guidance here.