What are the lessons learned from the dirty scopes investigation?

Our recent blog post, Medical Device “Emerging Signals”, updated about FDA’s intent to notify the public about “new information about a medical device used in clinical practice”. FDA’s intent to alert the public to the most current information known about a medical device to prevent potential risk to patients is a good concept — implementation requires cooperation from hospitals and medical device manufacturers.

In a blog entry posted January 13, 2016, Michael Mezher, RAPS, addressed a Senate report released on duodenoscopes that were found to be the source of infection in patients. In Mezher’s article, the report found hospitals did not report safety issues in a timely fashion to the medical device manufacturers who were then to report to FDA. Also, it was found that there were no reports in design changes that were made to the scope from the device manufacturers. The delays in reporting safety issues and design changes without review meant patients were at risk because the scopes were still in use.

Lessons learned – more oversight, guidance and improvements in reporting can be made for better outcomes. The report makes recommendations for the FDA to determine if a design change is necessary on the scopes, require unique device identifiers (UDIs) to improve device monitoring, and update guidance on when device manufacturers need to submit a new 510(k) for device modifications.  These recommendations were made in efforts to improve safety on medical devices.

FDA’s emerging signals draft guidance is a step to transparency and may result in less risk to patient health. The patient is counting on hospitals, device manufacturers and FDA working together responsibly.

To read Mezher’s complete article on RAPS.org, please click here. Contact us if you need regulatory filing assistance or quality system support to ensure your Medical Device Reporting (MDR) processes are compliant.

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The FDA issued a draft guidance document on December 31, 2015 entitled “Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). This draft guidance has been developed to provide more detail on FDA’s intent to notify the public about “emerging signals” regarding regulated medical devices.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.

Bioequivalence Complexities

The complex issue of testing for bioequivalence was covered in a recent article by Phil Taylor, In-pharma. It is recognized that the FDA has the very complex job of determining bioequivalence of generics to innovator products. Physicians and patients rely on FDA regulations for safety and efficacy of all drugs approved for use, including generics. To bring the FDA and physicians together to work in concert, the article discusses the benefit that could manifest when the FDA can share and disclose data and information used in justification for bioequivalence with physicians who make drug decisions on behalf of their unique patient needs. The physician, when armed with all of the information the FDA has about a drug, can be the best advocate for the individual patient when recommending drug therapy. The physician / patient relationship conducts the final “clinical trial” of whether a drug, generic or not, is effective & safe for the patient.

For more information on this interesting topic, please view Taylor’s article here.

Omnibus Appropriations bill gives more funding to FDA and NIH in 2016

The House Appropriations Committee announced the Omnibus Appropriations bill providing the FDA more funding this year for medical product safety initiatives. Funding is also directed to the Combating Antibiotic Resistant Bacteria (CARB) initiative, the Precision Medicine Initiative and the Orphan Product Development Grants Program.

The NIH will also receive more funding for Alzheimer’s disease research, brain research, antibiotic research and the Precision Medicine Initiative. An increase in funding will also be available for biomedical and translational research.

The additional funding from this bill means a victory for those patients waiting.

For more information, please read Melissa Fassbender’s entire article at in-Pharma. Pearl Pathways always has the patient in mind – contact us for help in accelerating your product development.


FDA is finding LDTs need more regulatory attention to protect patient health

According to Emily Wasserman of Fierce Medical Devices, “FDA is calling for more oversight of lab-developed tests (LDTs)”.  In a recent congressional hearing, FDA reviewed 20 case studies where certain LDTs “may have caused or have caused” harm to patients.  With this information, it seems that the current Clinical Laboratory Improvement Amendments (CLIA) regulations for LDTs are not comprehensive enough and more regulatory attention is required to protect patient health.

To check out Wasserman’s article click here.  Need help with mapping out your regulatory path for an LDT?  Contact us at Pearl Pathways.

FDA releases best practices drug development draft guidance

Melissa Fassbender, inPharma, recently published an article about the US Food and Drug Administration (FDA) and the new draft guidance on best practices for drug development. Stephen King, FDA spokesman, stated that the guidance’s purpose “is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effect drugs to the American people.” The guidance, being finalized in 18 months, will act as nonbinding recommendations.

To read Fassbender’s article, click here. To submit comments to FDA regarding this draft guidance, see this link.

FDA developing regulations for NGS

The US Food and Drug Administration (FDA) is planning to develop ways to better determine accuracy of predictions from regulatory testing of next-generation sequencing (NGS), according to FDA Commissioner nominee Robert Califf.

Michael Mezher states that FDA has been working on this development as part of the Obama Administration’s Precision Medicine Initiative. FDA is considering multiple approaches, such as a flexible design concept approach and a performance standards approach.

Up next, FDA will be hosting two workshops in the first quarter of 2016 to discuss further the plan and retrieve insight from the public. To read Mezher’s article on raps.org, click here. For more information about the November workshop held by FDA, click here. Need help with your regulatory path for your NGS diagnostic? Contact us.

FDA must clarify flexibilities

The U.S. Food and Drug Administration (FDA) has been called by multiple organizations to clarify its “regulatory flexibility” with orphan drug reviews, according to Michael Mehzer, RAPS. FDA released a draft guidance in August addressing the most common issues faced by drugmakers developing treatments for rare diseases. While many organizations, such as the National Organization for Rare Disorders (NORD), support the guidance, they request more specific information and examples on nonclinical studies, national history studies, endpoint identification, and trial design.

To read Mehzer’s article, click here. Need assistance in managing your orphan drug designation or regulatory filing? Contact us.

CDRH increases foreign inspections as planned

The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) released new data stating that the number of quality systems surveillance inspections for foreign manufacturers increased by 30%, despite the minor overall growth from 2013 to 2014. The increase in foreign inspections provides evidence that the center’s efforts have been working, according to Zachary Brennan, RAPS.

Currently, Chinese manufacturers are requiring more inspections, with Germany and Japan following suit. Although inspections increased abroad, the result of warning levels decreased. The chart below demonstrates the outcomes from domestic inspections compared to foreign inspections.

inspection outcomes

To read Brennan’s article on raps.org, 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.