Common Questions
How can we avoid receiving a Form 483 or Warning Letter?
The best way to minimize your chances of receiving a Form 483 is to always be "inspection ready." In other words, your quality management system should comply with US FDA 21 CFR Part 820 (Quality System Regulation) at all times because the FDA conducts random QSR audits with very little notice. Conduct regular internal audits of your QMS and learn what to expect from an FDA QSR inspection. Emergo can help with quality management system implementation and perform audits.
What if the Form 483 or Warning Letter results in a recall?
Emergo offers a range of post-market consulting services, including surveillance, vigilance, Field Safety Corrective Actions (FSCAs), and recalls. If you choose to withdraw your product from the US market in this situation, we can also help you design an exit strategy.
Additional services for United States:
- Consulting & Training for Medical Device Unique Device Identification (UDI) Requirements
- FDA 510(k) Submission Consulting and Approval
- FDA eMDR Adverse Event Reporting for Medical Device Companies
- FDA QSR Consulting
- FDA Submission for Medical Devices and In Vitro Diagnostics (IVDs)
- FDA US Agent Medical Devices in USA
- FDA認証(許可)取得のためのFDA 510(k)申請
- Human Factors Engineering (HFE) and Usability Testing for Medical Devices
- US FDA Consulting for Medical Device and IVD Manufacturers
- US FDA Medical Device Classification System
- US FDA Medical Device Establishment Registration
- US FDA Official Correspondent for Medical Device Companies
- US FDA Pre-Sub (Q-Sub) Consulting for Medical Devices