The Food and Drug Administration (FDA) recently released a draft guidance on voluntary recalls urging companies to institute recall plans and procedures in advance to ensure quick and effective execution when a recall is necessary: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. FDA broke the guidance into four main parts: (1) preparation for a recall; (2) response to a reported problem with a product; (3) initiation of a recall; and (4) FDA’s role in initiation of a recall. As firms develop plans for voluntary recalls, we recommend that they consult with counsel to ensure that they comply with regulatory requirements and appropriately address the concerns raised by the FDA in this draft guidance.
With the enactment of the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill), hemp-derived CBD appeared to be on the table for marketing all across the country. However, the U.S. Food and Drug Administration’s (FDA) press release issued that same day put a hold on the jubilation, stating that FDA considered any and all cannabis-containing or cannabis-derived products as drug products and not food or dietary supplements, regardless of whether the CBD was hemp-derived.
On April 2, 2019, departing FDA Commissioner Scott Gottlieb issued a statement about FDA’s next steps to advance a regulatory pathway for cannabis-containing and cannabis-derived products. At the same time FDA updated its cannabis-containing products and cannabis-derived products Q&A. It is clear that, at this point, FDA has not changed its position.
The Advanced Medical Technology Association (AdvaMed) has published its updated Code of Ethics. The updated code will become effective on January 1, 2020. AdvaMed has also published an overview of changes.
The updated AdvaMed Code now includes “Key Concepts” at the beginning of each section, with visuals, graphics, callout boxes, examples, explanations and FAQs.
The AdvaMed Code provides medical technology companies with guidance on ethical interactions and relationships with healthcare professionals (HCPs) to ensure that medical decisions are based on the best interests of the patient.
Because the medical technology industry is highly divergent, the AdvaMed Code drafters recognize no single compliance program fits each company. Therefore, AdvaMed encourages companies to adopt an “appropriately tailored” ethics and compliance program, accounting for the specific types of risks that apply to their operations. Companies adopting the AdvaMed Code are encouraged to submit to AdvaMed an annual certification stating adoption of the AdvaMed Code and implementation an effective compliance program.
Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate. The Food and Drug Administration (FDA) considers data integrity to be critical throughout the current good manufacturing practice (CGMP) to ensure product quality and public safety. In response to an increased number of data integrity violations, which have led to warning letters, import alerts and consent decrees, the FDA published a draft guidance on Data Integrity and Compliance with CGMP on April 14, 2016. After considering comments to the draft guidance, the FDA has now issued its Final Guidance on Data Integrity and Compliance with Drug CGMP on December 12, 2018. The Final Guidance is in a Q&A format and provides detailed instructions to the industry that reflects the FDA’s current thinking on data integrity.
On September 24, 2013, the Food and Drug Administration (FDA) issued a “final” rule regarding the Unique Device Identification System to adequately identify devices through distribution and use. The FDA has since issued several guidances updating implementation of the unique device identifier (UDI). On November 5, 2018, the FDA issued its latest UDI policy, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” which supersedes the direct marking deadlines mandated by an earlier guidance.
The Food and Drug Administration recently issued draft guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” Comments to this draft guidance should be provided by December 5, 2018.
FDA provides authorization for marketing a device when its benefits outweigh its risks. Uncertainty surrounding these benefits and risks is a factor that FDA considers when making its determination with respect to premarket approval application (PMA) approvals, de novo classifications, 510(k) clearances, humanitarian device exemption (HDE) approvals and investigational device exemption approvals. As it has in previous guidances, FDA attempts to provide “a flexible, patient-centric, benefit-risk approach” that is “tailored to the type and intended use of the device and the type of decision” required. For example, PMA and de novo requests require a demonstration of reasonable assurance of safety and effectiveness. However, HDE applications inherently have a greater uncertainty surrounding the benefit-risk profile as Congress provided that these applications need not show a reasonable assurance of effectiveness as the patient population is generally very small.
Section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes certain qualified third parties (3P Review Organizations) to conduct the initial review of premarket notification submissions for certain low-to-moderate risk medical devices. The 3P Review Program has been in existence since 1996, and the Food and Drug Administration (FDA) has modified aspects of the 3P Review Program from time to time to comply with changes in the statutory framework. The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, amended Section 523. In response, the FDA has now published a draft guidance, titled “510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations,” which modifies the 3P Review Program guidance. Comments and suggestions are due by December 13, 2018. When finalized, this guidance will supersede FDA’s guidance documents from 2001 and 2004.
On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), a combination of a number of previously passed House and Senate bills related to addressing the opioid crisis. One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.
Read the full text of this Alert on the Duane Morris LLP website.
The 510(k) process provides a review procedure for marketing clearance of devices that are “substantially equivalent” to other approved devices or to a standard recognized by the Food and Drug Administration (FDA).
On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)). The FDA calls the alternative the Quality in 510(k) “Quik” Review Program Pilot. Under the program, the FDA’s goal is “to make a final decision within 60 days.”
The U.S. Food and Drug Administration (FDA) recently published a report titled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS),” which summarizes stakeholder engagements completed in fiscal year 2013 and fulfills FDA’s Prescription Drug User Fee Act (PDUFA) commitment to issue a report of its findings regarding REMS standardization.