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FDA proposes to exempt 107 medical devices with new draft guidance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 This list was released as part of the August 1st draft guidance, allowing devices that are “sufficiently well understood and do not present risks that require premarket notification review to assure their safety and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 Following the proposal, FDA released a final rule with a complementary draft guidance for a standardized system to be run through their database known as the Global Unique Device Identification Database (GUDID), which serves as an industry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 Although some changes were made to the final guidance, FDA removed almost half of the content from the draft guidance stating that future revisions would contain more specific details for sections that have yet to be finalized.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.

MedTech growth in Latin America not slowing down

Latin America has become one of the fastest growing medical device markets due to the high amount of medical OEMs and suppliers entering the area for cost advantages. Chris Wiltz, of mddionline.com, reports that the areas medical technology market is already worth $10.5 billion and is on a path to reach $20 billion in 2015. Latin America offers an area of skilled workers, a large customer base, and an even larger budding economy.  As the graph below shows, the exponential growth has led to a combined GDP per capita that is over 10,000 times as large as the economy. Where do you think the ceiling is for MedTech in Latin America? Read the full article here.


China simplifying process for efficiency

Stewart Eisenhart, of Massdevice.com, reported that the China Food & Drug Administration (CFDA) is moving forward with improvements to their classification of medical devices process and is simplifying the road to the market for innovative devices. China has a three point plan to finish this project. First, create an online medium for medical device manufacturers to request regulatory validation of their product classification if they are unsure of its classification. In the past, it was purely a written process. Second, there will now be exemptions to the China Compulsory Certification (CCC) Mark certification that applies more to automotive, wireless, and consumer products. There will be only eight categories that will be exempt from the CCC. Finally, according to China Briefing, a new approval process can push new innovative devices into the market much quicker by having special circumstances and priority status to the review board. Will China be at risk with a less stringent path to market for innovative devices? Read the full article here.

First quarter medical deal declines may not reflect the state of the M&A industry

In a recent article on massdevice.com, Brad Perriello shares interesting data from Pricewaterhouse Coopers’ (PWC) US Pharmaceutical and Life Sciences Deals Insights Quarterly report Medical device mergers and acquisition deals in the first quarter fell from eight in the Q1 of 2012 to seven in Q1 of 2013. The same time comparison had the total value dropping from $2.3 billion down to $1.7 billion. Dimitri Drone from PWC purports that this decline is not necessarily reflected of the true deal activity. Active and not yet closed deals are not included in these numbers and Drone says “There’s a lot of talk about M&A among the people we interact with in medical devices.” The report still forecasts a growth overall in medical device M&A activity for 2013. What do you think?  Are you seeing more of an appetite for deals? To review the PWC report, click here, and for the full article click here.