FDA Medical Device Regulatory Consulting
Let Regulatory Compliance Solutions (RCS) guide you through the ever-evolving device regulations to successfully register your medical device. Medical devices range from simple tongue depressors to complex programmable pacemakers. We offer the following regulatory support for your medical device product approvals:
FDA Center for Devices and Radiological Health (CDRH) Medical Device Approvals
- Pre-Submission Support (regulatory strategy, FDA pre-submission meeting, etc.)
- Product classification (Food, Drug & Cosmetic Act Section 201(h))
- Exempt, Class I, Class II, Class III
- 510(k) or “premarket notification”
- De Novo (innovative pathway)
- Premarket Approval (PMA)
- Humanitarian Use Device (HUD) and Device Exemption (HDE)
- Submission preparation & filing
- Liaison between FDA-CDRH and the client