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.

Pearl Pathways Hires John Lockwood

head_shot_JLPearl Pathways announces the hiring of John Lockwood as a Senior Regulatory Compliance Advisor.

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.

EU passes new medical device legislation

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 contact@pearlpathways.com.

In July Pearl Pathways’ partner will be hosting a webinar

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 contact@pearlpathways.com.

Sarah Witwer’s teaching at Grace College this Fall

Pearl Pathways, Sarah Witwer, Regulatory Compliance Advisor will be a professor Grace College this coming fall 2015. Sarah has over 30 years of experience in the industry and is an experienced regulatory professional with expertise in developing regulatory strategies, filings, managing manufacturing issues, and more.

This will be her third year teaching a course in the Orthopaedic Regulatory and Clinical Affairs Program at Grace College in Warsaw, Indiana.

The course she will be teaching is entitled “RCA5500 Regulation of Medical Devices: Submission.” It is taught virtually and includes two weekends face-face in Warsaw, IN. This course encompasses the regulation and submission requirements for clearance of medical devices and is tailored toward the orthopedic industry.

Are you interested in learning more about Sarah’s class? Click here to learn more.

FDA to release draft guidance on approving medical devices using foreign trial data

Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not intended to announce a new policy, but rather articulate specific measures and considerations that must be applied when using such data to ensure the foreign medical device clinical data is adequate under FDA standards.

Such medical device manufacturers planning on submitting clinical data from outside the United States much provide the following information:

  • Detailed information about the research facilities and qualifications of the trial’s clinical investigators
  • Protocol and results summary
  • Full description of the device
  • Demonstration of the scientific validity for all of the gathered data
  • Ample assurances concerning informed consent

Ultimately, this guide document could provide clarity, help ensure the data is compliant with FDA standards, and allow products to reach the global market sooner.

To learn more, read Outsourcing-Pharma’s article by Zachary Brennan.