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 In a new draft guidance entitled General Wellness: Policy for Low Risk Devices, the Agency has confirmed their decision not to regulate products classified as “low risk general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.

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.