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Medical Device Regulatory Guidance

Medical device regulatory requirements are very detailed and require the appropriate diligence before a medical device can receive regulatory approval and go to market. Medical Device Consultants, Inc. is a full-service CRO, which has helped hundreds of medical device and diagnostics innovators to navigate the challenging journey from product concept to commercialization. Our medical device regulatory experts often refer to the following documents for medical device FDA guidance and for guidance in meeting Medical Device Directive (MDD) requirements and Canadian Medical Device Regulations. Contact MDCI today for help in meeting these complex medical device regulatory requirements.

FDA Medical Device Regulatory Guidance

510k FDA Guidance Documents and Memos

• Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff
• Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff
• The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance
• Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)
• Frequently asked questions on the 510(k) paradigm

Cardiovascular Device - FDA Guidance

• Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps
• FDA Guidance on Replacement Heart Valves

Dental Device - FDA Guidance

• Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions

IVD & ASR - FDA Guidance

• Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
• CLIA Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

Medical Devices with Antimicrobial Agents - FDA Guidance

• Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

Software for Medical Devices - FDA Guidance

• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Medical Device Risk Management - FDA Guidance

• Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management

Quality System - FDA Guidance

• Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
• The Quality System Regulation

Additional FDA Medical Device Guidance

• Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3)
• Design Control Guidance For Medical Device Manufacturers
• Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

International Medical Device Regulatory Guidance

Canadian Medical Devices Regulations

• Canadian Medical Devices Regulations (SOR/98-282)

Medical Device Directive Guidance

• EU Medical Device Directive - Council Directive 93/42/EEC.