USA Medical Device Regulations:
In the United States of America (USA), the Food and drug administration (FDA) controls and regulates the market access, entry, import, sales and use of medical devices, In vitro diagnostic (IVD) product and Software as a Medical device (SAMD). USFDA is one of the most regulated market for Medical Devices, IVDs and SAMD with proper, defined and pre-emptive registration pathways.
U.S. Medical Device Registration
Medical devices, IVD and SAMD registrations and submissions based on risk assessment and classification are very specific and different for every health authority.
- Athreva’s medical device experts can handle medical devices and IVD submissions and registrations effectively for United States Food and Drug Administration (USFDA).
QMS Compliance Services
Implementing and maintaining a quality management system (QMS) is a pivotal part of regulatory compliance for most markets around the world. Athreva has expertise to establish, maintain, and remediate your QMS requirements.
As a part of Athreva’s QMS compliance services, we offer
- Gap analysis to identify the applicable standards
- FDA QSR 21 CFR Part 820 consultation support for medical device and IVDs
- Support with Quality system ISO 13485 for medical device manufacturer
- Support for audit co-ordination and query response for ISO 13485
- Compliance with design control protocols
Regulatory Strategy and Approach
Acquiring the right regulatory strategy for medical device in US market is a complex process for successful product development, registration, and commercialization. It entails a lot of efforts from cross-functional teams to develop the device from conception to submission along with proper understanding of regulatory strategy needs. Athreva can support in developing appropriate and effective regulatory strategies.
- Classification strategy for borderline products
- Advise for combinational product submission
- Technical analysis of the product changes and categorization to critical and non-critical changes
- Update of technical file with the changes for submission to FDA
- Regulatory advice on change implementation with supporting documentation
US Agent Services
A manufacturer based in the United States and/or any part of the globe intending to manufacture, prepare for market access, entry, import, sale or distribute medical device or IVD must identify a local Agent based in USA. Athreva can expertly handle FDA interactions on your behalf and indulge with responsibilities like:
- Legal representation in USA with the FDA
- Providing a registered correspondence address in the US
- Incident reporting and complaint handling as per the manufacturer’s need
- Support for technical file submissions to the FDA
- Aiding the FDA in scheduling audits
- Interaction with the agency for submissions, queries, and additional information requests