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 Following the proposal, FDA released a final rule with a complementary draft guidance for a standardized system to be run through their database known as the Global Unique Device Identification Database (GUDID), which serves as an industry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 Although some changes were made to the final guidance, FDA removed almost half of the content from the draft guidance stating that future revisions would contain more specific details for sections that have yet to be finalized.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.

FDA releases social media draft guidance

Alexander Gaffney of raps.org posted an interesting article regarding the use of Internet and social media platforms in FDA regulated industry. Many companies have been using such resources to promote products and answer customer questions; however, FDA has been known to issue warning letters and sanctions for “unapproved” or “misbranded” commentary, leading industry to demand guidance. In response, FDA has released two draft documents outlining the requirements and limitations for the use of Internet and social media platforms among drug and device companies.

Released in June, the most recent draft guidance specifically applies to networks with character limitations such as Twitter and sponsored links via Google or Yahoo. As the guidance suggests, FDA is requiring each individual post to contain “material facts about the use of the product, such as limitations to an indication or the relevant patient population…and at a minimum, the most serious risks associated with the product.” For most companies, the task of generating a promotional message to fit these criteria within a limited number of characters is near impossible. FDA urges these firms to reconsider the use of certain social media platforms in this regard .

To read the full article, click here.

FDA proposing six new rules in the next year

The US Food and Drug Administration (FDA) has significant changes in regulation planned throughout the next year, as shared by Alexander Gaffney of RAPS.org. The article highlights six major proposals, five of which fall under the Drug Quality and Security Act (DQSA) of 2013. The following is a brief description of each rule, in order of anticipated or prior proposal release date:

  • Proposal granting FDA authority to destroy low-value drugs that are refused admission into the U.S. (May 6, 2014).
  • Modification of the list of drug products that may not be compounded as a result of the product’s removal from the market, due to safety and efficacy concerns (May 2014).
  • Rules regarding human drug compounding conditions within 503A and 503B facilities (October 2014).
  • Rule outlining the minimum requirements for good manufacturing practices (GMP) at outsourcing facilities (November 2014).
  • Revision of the current requirements regarding annual reports submitted to investigational new drug applications (INDs) to create consistency with the requirements endorsed by the International Conference on Harmonization (ICH). (March 2015).
  • Final rule establishing national standards for licensing prescription drug wholesale distributors and third party logistics providers (November 2015).

To read the full article, click here.

FDA and industry groups working to bring patient perspective into the regulatory process

Alexander Gaffney of RAPS.org posted an interesting article regarding FDA’s new Patient-Focused Drug Development Initiative, created to obtain patients’ perspectives on the severity of their conditions and the treatment options currently available. The goal is to increase patient involvement in the regulatory process.

FDA isn’t alone with this idea. In addition to PhRMA’s patient initiative that launched in November 2013, the advocacy group FasterCures is forming a Benefit Risk Advisory Council. Council members come from a variety of backgrounds including industry, patient and trade groups, rare disease advocates, academic institutions, and government. FasterCures’ intention with this group is provide feedback from stakeholders to drug developers and regulators.

To read the full article, click here.

Is FDA outnumbered in the fight to regulate medical apps?

There’s an app for just about everything, but how do you know which one to trust? There are nearly 80,000 medical apps available to the public; however, very few are tested and regulated by FDA, according to Varun Saxena’s article on fiercemedicaldevices.com.  As a result of the draft guidance released by FDA last year, the agency has decided not to use its regulatory authority on some lower-risk medical apps.

Because of this lack of regulation and testing, some apps with misleading information have slipped through the cracks. For example, a 2013 article on JAMA Dermatology’s website cited three apps that falsely diagnosed images of melanomas as benign more than 30% of the time. Such findings are alarming to industry and medical organizations, who are pushing FDA to increase regulation. For now, it is important for the public to understand: FDA is outnumbered by medical apps, the majority of which cannot be trusted just yet.

 

To read the full article, click here. Need help in determining how your medical app is regulated?  Contact us  at contact@pearlpathways.com.

FDA launches openFDA initiative

FDA has launched openFDA, a new “digital strategy” initiative intended to make government data and information more publicly accessible as covered by Alexander Gaffney of RAPS.org. The initiative began in January 2014 with the introduction of open.fda.gov, a website containing “open APIs (application programming interfaces), raw data downloads, documentation and examples, and a developer community of an important collection of FDA public datasets.”

Although it is still in the beginning stages of development, the website will enable healthcare and regulatory professionals to access FDA’s data without having to send hundreds of Freedom-of-Information Act (FOIA) requests. The ultimate goal of the openFDA initiative is to provide regulatory and adverse event data with the click of a mouse.

To read the full article, click here.

Google Glass, an emerging healthcare technology

The general public has been swooning over Google Glass since the introduction of the Explorer program last year, in which people could apply to be “the first to make, tinker, create, shape, and share through Glass.” A significant amount of these applications came from doctors and hospital affiliates wanting to incorporate the technology into their practice. Joseph Keenan’s article on http://www.fiercemedicaldevices.com explains the experiences and concerns of some doctors who have already begun working with Google Glass.

The technology associated with Google Glass allows doctors to view medical images, hold video conferences, stream operations online, and record what they see, all while performing a procedure. Additional software is currently in process to enable doctors to view a patient’s vital signs, medical history, lab results, and surgical checklists. While most agree this technology would be useful in the future of healthcare, there are still major privacy and safety concerns. Many hospitals and clinics have even decided to ban Google Glass pending FDA approval to avoid HIPAA non-compliance issues and safety risks.

Despite the risk factors, Google Glass presents medical practitioners with a unique opportunity for education and innovation. Keenan shares that one doctor, Dr. Selene Parekh, has been using Glass for over a year to record his orthopedic surgeries at Duke Medical Center. His goal is to be able to broadcast these surgeries as a learning tool for other surgeons in countries that may not be as up-to-date.  In another case, Dr. Paul Szotek, a trauma surgeon at IU Health Methodist Hospital here in Indianapolis, has been using Glass to give students a first-person perspective on medical procedures.

To read Joseph Keenan’s article, click here.

To read the article including Dr. Szotek’s work, click here.

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.

Closing the gap in the US drug import system

Alexander Gaffney of raps.org posted an interesting article regarding the current standing of the drug import system. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA may prohibit the import of any drug that has not been approved in the United States. Consequently, FDA is often required to either deny the product or detain it for further processing. This requirement presents a loophole to exporters: in the event that their product has been refused by FDA, its sponsor may request to have the drug returned (even misbranded or counterfeit drugs) and essentially gain the opportunity to resend it with a greater chance of passing inspection.

FDA’s major concern regarding these imports is the negative impact on consumer health because of misbranded dietary supplements and counterfeit drugs. In fact, FDA estimates that anywhere between 20 and 100 million packages containing drugs are imported into the U.S. each year, many from questionable online pharmaceutical sources.

In an effort to solve this issue of imported drugs, a proposition has been created granting FDA authority to destroy any refused drug without providing its sponsor an opportunity for return as long as the value of the drug is less than $2,500. In this case, the owner of the drug would then receive a notice of intent to destroy from FDA.

To read the full article, click here.

FDA completes rewrites of device pre-submission guidance

Alexander Gaffney from raps.org released an interesting article on FDA’s completion of the rewrite of device pre-submission guidance. FDA issued a guidance document to outline the changes and why these meetings are so important. They believe that the meetings offer a way to identify, clarify, and solve any obvious potential issues before the process starts. Also contained in the guidance are appendices that are associated with specific types of applications. To read the full guidance click here. To read the full article click here.