USA Regulatory ServicesAt Medreg, we help you determine the appropriate FDA classification for your medical device using the Authentic Classification Database. Our regulatory experts guide you through identifying the applicable regulatory pathway by decoding FDA regulation requirement, associated product code, risk class, predicate, applicable FDA guidance (Product performance and safety, process requirements, material standards, technology requirement & submission standards) by utilizing skill and knowledge.
Whether your device falls under Class I, Class II, or Class III, we support you in navigating the relevant regulatory requirements, including 510(k) submissions and Premarket Approval (PMA), as applicable.
- Class I (low risk): general controls – Medreg may help you to determine requirement of design control, GMP control (QMSR), Product listing, & firm establishment. We also provide US Agent services. Most of the class I medical devices are 510(k) exempted which require to be verified from FDA database. We also help for 510(k) documentation.
- Class II (moderate risk): general controls and Special Controls – Medreg may help you determine the requirements of design control, GMP control (QMSR), Product listing, & firm establishment. We also provide US Agent services. Very few of the class II medical devices are 510(k) exempted which require to be verified from FDA database. Whereas, most of the class II devices require Premarket Notification (510(k)). Medreg may help you for:
- 510(k) Documentation
- Predicate search
- Substantial Equivalence demonstration
- Executive Summary
- Labelling requirements (Immediate label, Instruction for Use (IFU), Surgical Technique, Packaging labels (secondary / tertiary))
- Biocompatibility Evaluation – Medreg have an expert Dr. Bipinchandra Trada (ERT, DABT, FASc(AW)) that can help you with Biocompatibility evaluation, Toxicological risk assessment, Biological evaluation strategy, Biological Evaluation Plan (BEP), Biological Evaluation Report (BER). For further information: Biotox
- Performance and Safety assessment
- Small Business Qualification
- MDUFA fees
- eCopy / eSTAR preparation and submission
- Interactive discussion with FDA reviewer
- Responding to additional information
- And deciding when to submit new 510(k) for any changes to FDA cleared device by following regulatory change assessment methodology.
