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.

FDA finalizes plan for an accelerated review program involving critical medical devices

As of April 15, 2015, a year after its initial proposal, FDA will begin to accept applications to participate in its new accelerated review program. The program is intended for critical devices defined as, “devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.” FDA plans to increase access to resources including senior management and case managers in order to leapfrog the acceleration review process. Ultimately, this accelerated review program will provide an avenue for potential life-saving devices to reach those patients in need sooner.

To learn more, read FDA’s guidance here.

Upcoming Second Annual BSI Mini-Roadshow Event on April 16th in Chicago

BSI logoThe British Standards Institution (BSI), the world’s first national standards body to partner with medical device manufacturers is holding its second annual Mini-Roadshow program on April 16th. The event topics include:

  • European Regulatory Update – CE, 13485, OBL
  • Clinical Data Evaluation – Lesson’s Learned
  • Compliance Navigator & Action Manager
  • Technical Files – Key Pitfalls
  • UAV & MDSAP Update

Presenters: Paul Brooks, Ibim Tariah, and John Bis

What: BSI Medical Device Mini-Roadshow

Where: Chicago Marriott Naperville1801 North Naper Boulevard Naperville, IL 60563

When: April 16th, 2015 from 8:30AM – 12:30PM

 

Registration is FREE! To register and learn more, click here.

We hope to see you there on April 16th!

 

FDA announces they will not regulate “low risk” general wellness devices

While mobile health apps and wearable devices have become exponentially more popular, FDA has explained they will not be regulating “low risk” general wellness devices. Traditionally, medical devices are required to obtain FDA approval or provide evidence of similarity to a preexisting product. In a new draft guidance entitled General Wellness: Policy for Low Risk Devices, the Agency has confirmed their decision not to regulate products classified as “low risk general wellness.” FDA defines such products as “solely intended for a general audience and presenting a very low risk to users’ safety.” Some examples provided in the guidance include exercise equipment, sleep, stress, or weight management devices, and other physical fitness products intended for recreational use.

For more information, read Alexander Gaffney’s article on RAPS.org here.

Pearl Pathways sponsoring, attending Asia-Pacific Device Summit in San Diego

Pearl Pathways is excited to sponsor its Asia partner and attend upcoming Asia-Pacific Summit for Medical Devices, a two-day intensive seminar on medical device regulations. This conference provides an opportunity to network and hear first-hand accounts from several local experts from Asia-Pacific. Some of the topics include managing growth, ensuring sales, marketing, and regulatory compliance, and structuring for flexibility, compliance, and success. We invite you to join us at the event!

What: Asia-Pacific Device Summit

When: March 5th – 6th, 2015

Where: Hilton San Diego Mission Valley Hotel

Prices will go up in February, so register here today!

We hope to see you in San Diego!

New FDA Approach to Medical Device Accessory Regulation

FDA has released a draft guidance on its new approach for defining and classifying new medical device accessory types. Device accessories have previously been classified in congruence with the parent device or as a completely separate classification regulation. The new FDA approach intends to classify the risk of the device when used with the parent device, as intended. In theory, this will provide a more accurate risk classification for the accessory devices, thus assuring the safety and effectiveness of the device.

In order to get new medical device accessories to the market more promptly, the guidance suggests that manufacturers use the de novo classification process to classify new types of device accessories.

Need help mapping out the regulatory path for your medical device accessory? Contact us at contact@pearlpathway.com.

To read Alexander Gaffney’s full article on raps.org, click here.