WASHINGTON--()--Greenleaf Health LLC today announced the availability of a new report, which analyzes U.S. Food and Drug Administration (“FDA” or “Agency”) enforcement data across the medical device industry. Greenleaf Health is a full service regulatory consulting firm that provides strategic guidance to companies regulated by the FDA and those developing innovative solutions to pressing public health challenges around the globe.
The new report, titled “The FDA Medical Device Enforcement Report,” provides an assessment of enforcement trends based on thousands of data points from difficult to access, publicly-available FDA databases and sources. Within the report, Greenleaf provides an analysis of FDA enforcement trends across the medical device market and considers how enforcement trends will affect manufacturers.
Since 2009, FDA has made enforcement one of the Agency’s top priorities. Over the last four years, FDA leadership has actively worked to strengthen and emphasize the importance of the Agency’s enforcement policies – as a result, FDA enforcement activities have increased steadily. Regulatory and procedural changes have redirected the course of FDA’s enforcement functions and will have long-lasting effects on regulated industry.
To provide regulated industry with a comprehensive understanding of FDA enforcement trends, Greenleaf’s enforcement report focuses on four specific areas of medical device enforcement data: FDA inspections; FDA Form-483 (“483”) observations; warning letters; and product recalls. The report provides an overview of FDA’s policy for each enforcement action and draws conclusions based on the following data:
- Inspections: Rate of inspections over a 5-year period; analysis of FDA decisions and project areas; individual district inspection activity; and company size.
- FDA Form 483: Frequency of 483s issued by the Center for Devices and Radiological Health (“CDRH”) over a 5-year period; comparison of CDRH 483s versus other FDA 483s; and observations made via 483s.
- Warning Letters: Frequency of Warning Letters issued by CDRH; subject of violations; issuing office and/or district; company size; and a comparison of Warning Letters as they relate to 483s and inspections.
- Recalls: Frequency of recalls by class; comparison of FDA versus CDRH recall totals; and analysis of frequency based on company size.
An executive summary of Greenleaf’s enforcement report may be accessed at the following link: http://www.greenleafhealthllc.com/greenleaf-health-medical-device-enforcement-report/
Along with the development of the Enforcement Report, members of the Greenleaf team are experienced at providing a comprehensive assessment of specific company trends and providing a detailed analysis of company interactions with FDA, including responses to Warning Letters, FDA Form-483s and other communications.
Greenleaf’s enforcement and compliance team is led by former FDA Associate Commissioner for Regulatory Affairs, Michael Chappell. Chappell’s extensive FDA experience brings a unique understanding of how regulated industry is impacted by FDA’s enforcement operations. Chappell joined Greenleaf following a distinguished 38-year career in FDA’s Office of Regulatory Affairs where he most recently served as head of the Agency’s Office of Regulatory Affairs.
Additional compliance and enforcement related services provided by Michael Chappell and the Greenleaf team include:
- Meeting with company management to discuss FDA enforcement philosophy
- Strategic assessment of your organization’s Quality Systems
- Assessment of Inspection Readiness and engagement with the inspectional team
- Assessment of FDA Enforcement Responses / Remediation (483s, Warning Letters, other communications)
- Analysis of Quality Systems & Training Programs
- Assessment of Corporate Compliance Systems
- Recommendations on how to strengthen your Quality & Compliance Organization(s)
For full access to the report, or to learn what other services Greenleaf Health may provide your company, please visit www.greenleafhealthllc.com