CDRH Transparency: Compliance & Enforcement
The FDA conducts inspections of medical device manufacturers to check that they are complying with medical device regulatory requirements. When a medical device manufacturer fails to comply with these requirements, the FDA responds with tools that include warning letters and recalls. In most cases, a company (manufacturer, distributor, or other responsible party) will take voluntary action to correct the violations identified by the FDA.
The CDRH Inspections Database provides information about FDA medical device inspections from 2008 to the present. The database contains information about the firms, types of devices and inspections, and links to warning letters (when available).
Each year, the FDA conducts inspections of medical device manufacturers to assess compliance with regulatory requirements, including the Quality System regulation. These inspections can result in the issuance of document known as a “Form 483,” named for the form on which the investigator records any observations.
After an inspection, FDA staff reviews the Form 483 and decides whether agency action is needed to assure correction of the cited violations.
Compliance and Enforcement Actions
- Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs)
- Warning Letters
- Letters to Industry
- CDRH Recall Database
- FDA Enforcement Activities
- List of Device Recalls
- Letters to Health Care Providers
Quality System Data
- FDA Medical Device 2017 Quality System Data: Analysis of 2017 Inspection Observations and Warning Letter Cites
- FDA Medical Device 2016 Quality System Data: Analysis of 2016 Inspection Observations and Warning Letter Cites
- FDA Medical Device 2015 Quality System Data - Analysis of 2015 Inspection Observations and Warning Letter Cites
- FDA Medical Device 2014 Quality System Data - Analysis of 2014 Inspection Observations and Warning Letter Cites