US FDA Consulting for Medical Device and IVD Manufacturers
ANSWERED ON THIS PAGE:
- Why does third-party FDA consulting makes sense for some medical device companies?
- Which aspects of the FDA premarket review process can be helped by third-party consulting?
- Which types and sizes of medical device firms stand to benefit from using third-party consulting to interact with US regulators?
As the US Food and Drug Administration’s medical device and IVD review process becomes more complicated, partnering with an experienced FDA consultant can make a significant difference in your market authorization and compliance efforts.
Whether your goal is to implement a quality management system that complies with the FDA Quality System Regulation (QSR) or obtain 510(k) premarket notification clearance, a skilled FDA consulting firm can assist you in meeting all US regulatory requirements.
Founded in 1997, Emergo has extensive experience providing FDA consulting to medical device and IVD manufacturers of all sizes seeking to bring their products to the US market. We have assisted medical device manufacturers worldwide with US FDA device classification, registration, premarket clearance/approval, in-country representation and quality system compliance.
FDA consulting services we offer:
- FDA 510(k) submissions for obtaining FDA clearance
- FDA Investigational Device Exemption (IDE) submissions for US clinical studies
- FDA Requests for Classification and Requests for Determination
- FDA Pre-Submission (Pre-sub) meetings
- FDA QSR Consulting (21 CFR Part 820) for medical device and IVD manufacturers
- US Agent representation for manufacturers based outside the US
- FDA QSR training for medical device companies
- QSR (21 CFR Part 820) audits for medical device companies and their suppliers
- FDA Form 483 Warning Letter analysis, response and recovery
- General regulatory and quality system assistance and training
Why choose Emergo as your FDA consulting firm?
- We offer effective FDA regulatory support for all sizes of firms--from small, start-up medical device companies to large, multi-divisional corporations
- Our FDA consulting services are fully tailored to address your particular business needs
- Our FDA consulting and project management teams coordinate efforts to deliver your services on time and within budget
- We maintain constant accessibility and support both on- and off-site during the course of your FDA consulting project
Contact us today for more information on our FDA consulting services.
Who owns a 510(k) premarket clearance? Can ownership be transferred?
The person who possesses the premarket clearance for a device is considered the 510(k) holder. If a 510(k) premarket clearance is sold or otherwise transferred to another entity, the FDA is notified via compliance with annual device listing requirements.
How long is my 510(k) premarket clearance valid?
An FDA 510(k) premarket clearance is valid until changes are made to the device that could either significantly affect its safety or effectiveness, or its intended use. Changes need to be assessed to determine if a new 510(k) submission to the FDA is warranted.
Can multiple medical devices be included in a single submission?
Devices that share the same FDA classification regulation/product code can often be “bundled” into a single regulatory submission.