Accelerate your product development.

Regulatory Services

Development Process Submissions

  • FDA Presubmission Meetings, e.g., Pre-IDE, Pre-510(k), Pre-HDE, Pre-PMA

    These meetings are held to obtain informal FDA feedback prior to submission of the specified document.

    MED can work with you to develop your meeting strategy and prepare the meeting request package, as well as assisting in or leading interactions with the FDA

  • PMDA Preconsultations and Consultations

    At these face-to-face meetings, medical device companies discuss the planning and implementation of clinical trials and major marketing authorization submissions with the PMDA (the regulatory authority in Japan).

    MED has been responsible for 15 Pre-/Major consultation meetings and 7 GCP conformity audits, and has been an active contributor to the PMDA and FDA’s “Harmonization By Doing” group. These interactions have helped MED build relationships with the PMDA and have given MED a deep understanding of PMDA culture.

  • IDE (Investigational Device Exemption)

    An IDE application requests approval to conduct a clinical investigation of a significant risk device in the U.S. The application must document nonclinical testing supporting safety, and provide a clinical investigation protocol as well as other background information.

    MED has written dozens of original IDEs and IDE supplements that the FDA approved.

  • 513(g) Request for Information

    This filing helps you obtain FDA’s views about the classification and the regulatory requirements that may be applicable to your particular device.

  • HUD (Humanitarian Use Device) Designation

    This application must demonstrate that a medical device is intended to benefit patients in the treatment or diagnosis of a disease or condition that affects fewer than 8,000 individuals per year in the U.S.

    In addition to writing the application, MED researchers can perform literature research to determine if your device meets the HUD threshold.

  • RFD (Request for Designation)

    An RFD is submitted to the FDA to determine the regulatory status of a product as a drug, device, biological product, or combination product. If the product is designed as a combination product, the RFD will also determine which center of the FDA will have primary jurisdiction for regulating your product.

  • IND (Investigational New Drug)

    This is an application required to conduct a clinical trial of a new drug in the U.S.

  • CTA (Clinical Trial Application)

    This application is required to conduct a clinical trial of a drug in Canada.

  • ITA (Investigational Testing Authorization)

    This application is required to conduct a clinical trial of a medical device in Canada.

    MED can work with you to develop your meeting strategy and prepare the meeting request package, as well as assisting or leading interactions with Health Canada.