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.
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 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.
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.
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.
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.
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).
Lockwood has over 20 years of experience in quality, regulatory, auditing, and purchasing roles in the life sciences industry. In addition to holding a variety of positions within small and large medical device manufacturers, he also brings nearly a decade of experience in consulting and operations. Prior to joining Pearl Pathways, John led the quality function at an Indianapolis based laser medical device company.
To read the full press release click here.
After years of European regulators pushing for a new legislation framework and weeks of speculation, the European Council (EC) seems to have made some progress and agreed to approach the new framework for medical devices and IVD (in vitro diagnostics) laws.
The original proposed guidelines started in 2012 with the goal of being adopted in 2014. However, the current discussions have carried over into 2015, and it but still does not look like it will pass until after the Latvian presidency ends this month. The EC is hoping adoption of these regulations will occur soon so they can promote increased reliability and safety to patients, as well as ensure that medical devices and IVDs are up to date with technological and scientific advances.
To find out more on the new framework legislation and the changes that will occur, continue reading here.
Need help with regulatory submissions for medical devices and IVD’s in the EU? Our staff is here to help. Email us at email@example.com.
Brandwood BioMedical is hosting a webinar entitled ‘Australia’s “Fast Track” pathway of device registration for local manufacturers.’ The topic of the webinar will provide more information on how to take advantage of the new TGA policy announced in Q4 2014 which removes the requirement for manufacturers to undergo direct TGA conformity assessment, and apply for registration instead using CE certification.
This webinar could help you save time and money.
Date: July 7th
Time: 12:00pm – 1:00pm (AES), 10:00pm on July 6th (EST)
To register for the webinar click here.
Do you plan to register a medical device in the Asia Pacific region? If yes, sign up for this webinar and contact us at firstname.lastname@example.org.