Medical Device “Emerging Signals”

The FDA issued a draft guidance document on December 31, 2015 entitled “Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). This draft guidance has been developed to provide more detail on FDA’s intent to notify the public about “emerging signals” regarding regulated medical devices. FDA defines an emerging signal as “new information about a medical device used in clinical practice: 1) that the Agency is monitoring or analyzing, 2) that has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device, 3) that has not yet been fully validated or confirmed, and 4) for which the Agency does not yet have specific recommendations.”

An “emerging signal” would alert the public to the most current information known about a medical device. The intent is to prevent potential risk to patients. Opponents to this idea are asking why the FDA would release information that has not been fully verified / investigated by the FDA. For more information, read Zachary Brennan’s article on RAPS.org.

Medical Device Tax suspended for two years = good news for Medical Device Companies and Patient Health

President Barack Obama recently signed a bill suspending the Medical Device Tax for two years. It took a great combined effort of many large and small medical device companies to make this happen, many from Indiana. This outcome greatly benefits all medical device companies. Hopefully, now the monies that companies would have earmarked toward taxes could now instead be put into new product development. This investment in R&D could also drive more jobs and ultimately more innovative solutions to improve patient health.

After learning of the suspension, Fred Hite, CFO of OrthoPediatrics of Warsaw, Indiana stated “Luckily now we’ll be able to go back and review that and remove the expense and cash that we had put in to the budget for the medical device tax and instead replace that with incremental programs developing new projects.”

Great news for medical device development. To read Varun Saxena’s full article about this topic in Fierce Medical Devices, click here. The Pearl Pathways team is ready to partner with your team on your new projects to improve patient health, contact us.

Register now for the Asia Pacific Device Summit

On March 10-11, 2016, the Asia Pacific Device Summit will be held in San Francisco, CA. This event will bring together medical device experts from Asia and the US. Click here for more information. Register for the event through Brandwood Biomedical, Pearl Pathways’ strategic international partner.

Save the date: IMDMC Medical Device event at the Statehouse February 3, 2016

On February 3, 2016 the Indiana Medical Device Manufacturers Council (IMDMC) will be hosting the annual Medical Device Exhibit and Breakfast at the Indiana Statehouse. This event provides the opportunity to interact with state and federal officials about the industry. To register for the event, click here.

 

Register now for greenlight.guru’s December 8th webinar on medical device risk management

On Tuesday, December 8th at 1:00pm. EST, greenlight.guru, Pearl Pathways’ strategic partner for eQMS, will be offering a webinar about how to manage risk in new product development, specific to medical devices. By attending this webinar you will learn the in’s and out’s of quantifying risks and how to leverage risk management in supporting your medical device product development. Click here to register now.

2015 top 10 women

Fierce Medical Devices announced the release of their list of top women in medical devices in 2015. The list is comprised of ten women across the nation of who have made an impact in the medical device industry this year. To access the article and list, click here.

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.