Services: FDA Regulatory Consulting
We take care to understand each client's US and global business objectives to assure that the regulatory strategy complements and supports plans for commercialization. In addition to preparing 510(k)s, IDEs, and PMAs and assuring FDA clearance or approval, we have successfully submitted a number of de novo petitions (de novo 510(k)s), we have contributed to both industry-sponsored and FDA-sponsored reclassification petitions, and we have taken a number of products through the Humanitarian Device Exemption (HDE) process.
FDA Regulatory Services offered by M Squared Associates include:
- Regulatory Strategy
- Registration and Listing
- Presubmission Packages and Meetings
- 510(k) Premarket Notifications
- De Novo Petitions / De Novo 510(k)
- Investigational Device Exemptions (IDE)
- Humanitarian Device Exemptions (HDE)
- Premarket Approval Applications (PMA)
- FDA Advisory Panel Presentations
- 513(g) Requests for Classification Information