Pearl Pathways announces global partnership with Brandwood Biomedical

Pearl Pathways is pleased to announce a partnership with Brandwood Biomedical, an Australia-headquartered regulatory and quality services company with offices throughout Asia. This collaboration allows both companies to provide on-the-ground support to clients and better adapt to the changes and complexities associated with global markets. For more information, read our full press release here.

In addition, Pearl Pathways and Brandwood Biomedical will be hosting the The Asia-Pacific Summit for Medical Devices, a two-day intensive seminar on medical device regulations featuring a variety of local experts from Asia-Pacific.

When: March 5-6, 2015

Where: Hilton San Diego Mission Valley Hotel

Register here before December 5 to enjoy the lowest early bird pricing!

We hope to see you in San Diego!

Pearl Pathways attending, sponsoring IMDMC annual conference – November 6

imdmcPearl Pathways is excited to be attending and sponsoring the IMDMC Annual Conference tomorrow, November 6 at the Montague Banquet Center in Indianapolis. This conference provides an opportunity for networking, collaboration, and discussion of recent news and trends within the medical device industry. Dr. Kimber Richter from the FDA Office of Compliance will present this year’s keynote speech on “FDA Assessment of Risk/Benefit in the post Market/Recall Space.”

When: Thursday, November 6

Where: Montague Banquet Center, 8580 Allison Pointe Blvd, Indianapolis, IN

We encourage you to stop by our exhibitor booth to meet our talented staff! For more information about IMDMC, click here.

New whitepaper from Pearl Pathways “Types of In Vitro Diagnostics: Clearing up the Confusion”

By definition, all in vitro diagnostics (IVDs) for human use are medical devices. That much can be easily understood: however, classifying medical devices under the IVD umbrella can become complicated when the difference between each category is often unclear. There are many roadblocks to bringing a medical device to market, but spending time on product classification and sifting through FDA guidance documents doesn’t have to be one of them.

Pearl Pathways has published a new whitepaper entitled “Types of In Vitro Diagnostics: Clearing up the Confusion.” The paper discusses the many categories of IVDs and their requirements and regulations. These categories include RUOs, IUOs, ASRs, LDTs, Companion Diagnostics, and IVDMIAs. This paper is a must read for anyone involved in the development of IVDs.

Click here to read!

FDA moves to reduce cybersecurity threats in medical devices

FDA has released a final guidance document and collaborated with the National Health Information Sharing & Analysis Center (NH-ISAC) as part of their effort to protect patient privacy and prevent cyber-security threats in medical devices. The guidance suggests that manufacturers identify potential security risks and submit action plans to FDA to reduce vulnerability.

FDA’s additional partnership with the NH-ISAC will help foster the relationship between healthcare providers and security experts and provide programs to further minimize cyber-security threats. These threats came to light last year when two Department of Homeland Security researchers discovered a hard-coded password vulnerability affecting approximately 300 medical devices.

Click here to read Patrick Ouellette’s article on healthitsecurity.com. For additional information, read FDA’s final guidance and memorandum of understanding with the NH-ISAC.

FDA proposes to exempt 107 medical devices with new draft guidance

In an effort to simplify the approval process for low-risk medical products, FDA has exempted 107 medical devices from its 510k premarket notification regulations. This list was released as part of the August 1st draft guidance, allowing devices that are “sufficiently well understood and do not present risks that require premarket notification review to assure their safety and efficacy” to be marketed without a 510k submission, given that the device meets all other regulatory requirements.

FDA has granted exemptions for medical devices such as portable air compressors, fluid-filled teething rings, surgical lights, and obstetrical forceps.

To read Joseph Keenan’s article on Fierce Medical Devices, click here.

FDA releases final guidance on GUDID with more revisions to come

Back in 2012, FDA proposed to establish a unique device identification (UDI) system to track and identify medical devices in the US. Following the proposal, FDA released a final rule with a complementary draft guidance for a standardized system to be run through their database known as the Global Unique Device Identification Database (GUDID), which serves as an industry resource for product labeling information.

On June 27, FDA issued final guidance on the use of the GUDID with an approach that surprised many industry representatives. Although some changes were made to the final guidance, FDA removed almost half of the content from the draft guidance stating that future revisions would contain more specific details for sections that have yet to be finalized.

To read an article by Alexander Gaffney’s on raps.org explaining the guidance, click here. To review the guidance document on FDA’s website, click here.

Need help with enhancing your UDI processes?  Contact us at contact@pearlpathways.com.

New discovery wirelessly powers internal medical devices

Jennifer Hicks posted an interesting article on forbes.com about a new discovery to power implantable medical chips and devices which are intended to treat illness or relieve pain without drugs. Engineers at Stanford University have been working to rid these medical devices of batteries and recharging systems, which have restricted the use of these devices for years.

Ada Poon, assistant professor of electrical engineering, had the idea to wirelessly power or recharge internal devices with an external power source using electromagnetic waves. Her challenge in using electromagnetic waves was finding a middle ground between the two extremes—far-field and near-field. Poon needed to accomplish the distance of far-field waves and the safety of near-field waves in order to make the transfer from air to skin, and successfully power an internal device. By creating a power source using a mid-field wireless transfer, she was able to do just that.

To read the full article, click here.  Need help with regulatory filings of your medical device?  Contact us at contact@pearlpathways.com .

FDA announces a public discussion on 3-D printing considerations

Leslie Kux, Assistant Commissioner for Policy at the Federal Register, posted an event notice regarding a public workshop on “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing,” hosted by FDA. The intention of the workshop is to provide a forum for discussion on technical challenges and solutions of 3-D printing.

3-D printing, or additive manufacturing, is a technique used to create devices by layering necessary material based on a computerized model or blueprint. This technique allows designers to make quick alterations for prototype iteration or production of multiple product designs. Combining this technology with a patient’s own medical imaging, anatomically matched devices or surgical guides can be created.

FDA has already received submissions for additively manufactured medical devices and is forecasting substantial growth in the industry over the next ten years, which is motivation for hosting this workshop. FDA is seeking the perspective of stakeholders by discussing scientific and technical challenges associated with additive manufacturing. The information gathered at the workshop may aid to the development of new draft guidance and standards to ensure patient safety and support innovation.

To read the full event notice, click here.

European Commission enacts new rules concerning Notified Bodies

Louise Zornoza reports on Raps.org that on September 24, 2013, the European Commission issued new rules creating a new EU process for designating and monitoring Notified Bodies. The new rules establish the basis for withdrawal and clarify the required expertise of these groups. Notified Bodies are responsible for the oversight of local manufacturers of medium and high risk medical devices. There are currently 80 Notified Bodies in the European Union, which all conduct audits and issue CE markings for medical devices. The new rules describe the designation of a Notified Body as well as the monitoring of such body to reaffirm its compliance and use. For the full article and new rules, click here.

Brazil: ANVISA beginning to update and revise regulatory system

Stewart Eisenhart, of massdevice.com, explains that Brazilian medical device regulator ANVISA is planning a multitude of updates and revisions to Brazil’s existing regulatory system to be enacted by the end of 2014.  These proposed changes will affect almost all quality management system requirements and registrations currently in place.  Although none of the alterations have been enacted yet, the announcement of a list of medical device and in vitro diagnostic issues targeted displays ANVISA’s plan is coming to fruition. If all the changes are to be enacted by the end of 2014, Brazil will have more efficient, cost effective market access for foreign manufacturers. Do you think Brazil could begin to be a major player in foreign manufacturing in the next five years? For the full article click here.