Introduction: Understanding FDA Risk Information for Approved Medical Devices
The U.S. Food and Drug Administration (FDA) announced an additional “unique type of restriction” on the sale and distribution of an approved medical device, reinforcing the importance of transparent FDA risk information. The FDA issued an order requiring healthcare providers and facilities that offer the Essure permanent contraception device to provide specific, standardized information to patients regarding the risks and benefits associated with the device.
This action highlights FDA’s evolving regulatory approach and its willingness to implement enhanced oversight mechanisms to ensure that critical risk information is effectively communicated to patients and end users.
Looking For a Medical Device Regulatory Consultant?
FDA Restriction on Sale and Distribution of an Approved Medical Device
This was not the first regulatory step taken by the FDA to strengthen the presentation of risk information related to the Essure device. However, the latest action signifies FDA’s readiness to use new regulatory tools to oversee how approved medical devices are promoted and distributed in the U.S. market.
Under this requirement, FDA introduced a new level of physician–patient engagement focused specifically on documented risk communication.
Patient Decision Checklist: Strengthening Risk Communication
As part of the FDA order:
Patients must be provided with an opportunity to review and sign specific sections of an approved Patient Decision Checklist.
The implanting physician is required to sign the same checklist to confirm that:
- The benefits and risks of the device have been discussed
- The benefits and risks of available alternatives have been explained
- All patient questions have been adequately addressed
This documentation ensures accountability and confirms that informed decision-making takes place before device implantation.
Updated Labeling and Advertising Requirements
FDA further mandated that all labeling and advertising for the device must clearly state that:
Sale and distribution are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling.
This requirement integrates risk disclosure directly into both promotional and clinical communication channels, reinforcing patient safety.
FDA 510(k) Clearance & Premarket Approval for Medical Devices
Operon Strategist supports manufacturers throughout the FDA 510(k) clearance and Premarket Approval (PMA) process for medical devices. Our consulting services include:
- Registration of Small Business Units (SBU), where applicable
- Identification and management of testing requirements
- Preparation and submission of the regulatory dossier
- Resolution of FDA queries until completion of the approval process
Regulatory Background and Post-Market Surveillance
This latest FDA requirement follows a November 2016 labeling update for the product, which introduced:
- A boxed warning
- A Patient Decision Checklist intended to supplement patient counseling
At the time of approval, FDA referenced allegations raised through a trade complaint originally submitted as a Citizen Petition. To further assess the device’s safety profile, FDA had already ordered the manufacturer to conduct a post-marketing surveillance study in February 2016.
FDA’s Position on Patient Risk and Market Availability
This regulatory action demonstrates FDA’s balanced approach when managing medical devices that present potential patient risks. In a March 2018 statement, FDA Commissioner Scott Gottlieb emphasized that:
FDA continues to believe that the product may be appropriate for some women based on current information.
The agency did not remove the device from the market. Instead, FDA chose to strengthen risk communication requirements, signaling that more assertive regulatory measures may be implemented when the agency believes critical risk information is not effectively reaching patients.
Enforcement and Compliance Expectations
FDA confirmed that it will actively review and monitor the manufacturer’s compliance plan and stated that it:
- Plans to enforce these requirements
- Will take appropriate action in cases of non-compliance
- May impose criminal and civil penalties if requirements are not met
Although the full compliance plan details are not publicly available, FDA’s approach closely resembles Risk Evaluation and Mitigation Strategies (REMS) used in the pharmaceutical regulatory framework.
Partner with Operon Strategist to ensure FDA compliance, streamline approvals, and safeguard patient safety.
The Role of Operon Strategist in FDA Risk Compliance
As FDA strengthens oversight on approved medical devices and emphasizes transparent risk information, regulatory compliance is more critical than ever. Navigating evolving requirements like restricted distribution, enhanced labeling, and documented patient risk communication demands expertise. Operon Strategist supports manufacturers by interpreting FDA expectations, aligning labeling and risk communication strategies, and assisting throughout 510(k) clearance and Premarket Approval pathways, helping organizations maintain compliance, reduce regulatory risk, and ensure patient safety while keeping approved devices accessible.
In addition to FDA risk compliance and labeling strategy support, Operon Strategist offers a comprehensive portfolio of medical device regulatory consulting services that can be seamlessly aligned through internal regulatory planning and execution. These services include FDA 510(k) consulting, Premarket Approval (PMA) support, Medical Device Registration and Listing, Quality Management System (QMS) implementation as per 21 CFR Part 820 and ISO 13485, Post-Market Surveillance and Vigilance support, and Regulatory Gap Assessment services. By integrating these services, Operon Strategist enables manufacturers to build a strong, compliant regulatory foundation across the entire medical device lifecycle.
FAQs
What is FDA risk information for medical devices?
FDA risk information details the potential hazards, benefits, and safety considerations associated with approved medical devices.
Why is the Patient Decision Checklist required?
The checklist ensures patients are informed about device risks, benefits, alternatives, and that physicians have addressed all patient questions.
What are FDA’s enforcement measures for non-compliance?
FDA may impose civil or criminal penalties, and monitors compliance similarly to REMS programs.
How can Operon Strategist help with FDA approvals?
Operon Strategist provides guidance on FDA 510(k) clearance, PMA approval, risk communication, labeling, and other regulatory services.
