Strategic Regulatory Services for Medical Devices and Combination Products
GZP offers a full range of strategic regulatory consultation services for medical device companies and sponsors of combination products. From initial classification and pathway determination through premarket submissions, inspections, and post-market surveillance, GZP’s experienced team provides objective, expert guidance at every stage of the device development lifecycle.
GZP’s combination product expertise is a particular strength — navigating the complex intersection of CDER, CBER, and CDRH jurisdictional requirements demands a team with cross-disciplinary depth, and GZP brings exactly that.
Medical Device Services
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Strategic Regulatory Consultation
- Regulatory pathway assessment and classification determination
- Planning for regulatory compliance — executive and investor briefings
- Interactive strategy development for 510(k), De Novo, PMA, and IDE submissions
- US Agent services for non-US companies intending to market products in the United States
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Premarket Submissions
- Premarket Notification — 510(k): preparation, submission, and maintenance
- Premarket Approval — PMA: preparation, submission, and maintenance
- De Novo classification requests
- Investigational Device Exemptions (IDE): program establishment and maintenance
- Q-Submissions and pre-submission meeting packages
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Assessment & Audit Services
- Independent quality system audits per Quality System Regulation (QSR/21 CFR Part 820)
- IDE compliance assessments
- Labeling format and content review
- MDR (Medical Device Reporting) program development and compliance review
- Recall strategy development — proactive and reactive
- Export compliance assessments
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Registration & Listing
- Establishment registration and device listing — timely and accurate compliance
- Post-market surveillance program design
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Combination Product Services
Combination products — those that include a drug/device, biologic/device, or drug/biologic component — require a uniquely integrated regulatory approach. GZP’s cross-disciplinary team is well-positioned to navigate the assignment of primary mode of action (PMOA), interact with FDA’s Office of Combination Products (OCP), and coordinate across CDER, CBER, and CDRH requirements.
- Combination product classification and PMOA determination
- RFD (Request for Designation) preparation and submission
- Integrated regulatory strategy spanning drug, biologic, and device requirements
- CMC support for drug-device combination products
- Design control integration with IND/NDA/BLA development
Frequently Asked Questions – Medical Devices & Combination Products
What types of medical device submissions can GZP prepare?
GZP can prepare and manage all major device submission types, including 510(k) premarket notifications, PMA applications, De Novo classification requests, Q-Submissions (pre-submission meetings), and Investigational Device Exemption (IDE) applications.
Can GZP help determine whether our product is a device, drug, biologic, or combination product?
Yes. This classification question is often one of the most consequential early decisions a sponsor can make. GZP can assess your product’s primary mode of action, advise on classification, prepare a Request for Designation (RFD) to FDA’s Office of Combination Products if needed, and help develop the appropriate regulatory strategy from there.
Do you support international device companies entering the US market?
Yes. GZP provides US Agent services for non-US companies intending to market medical devices in the United States, and can manage establishment registration, device listing, and all required agency interactions on your behalf.
What does a quality system audit from GZP involve?
GZP conducts independent, objective audits for conformance with FDA’s Quality System Regulation (21 CFR Part 820) and ISO 13485. We assess existing compliance systems to identify gaps, inconsistencies, or redundant activities, and provide practical recommendations for remediation and streamlining.
Have additional inquiries?
We are here to help. Let’s engage in a conversation.