Regulatory Services

Work with a dedicated team.

If you come to MED Institute for support with regulatory submissions, we’ll partner with you to figure out the best way to get your product approved. The regulatory process can be a long one, but throughout the process, we’ll treat you like a colleague, not a client.

MED Institute can help you develop regulatory strategies for everything from product development to final marketing approvals and postapproval support. At every stage, we’re using fundamental science and data to show how the product meets regulatory requirements.

Development Phase 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 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 Japanese PMDA.

MED has been responsible for 15 Pre-/Major consultation meetings and 7 GCP conformity audits, and has participated in 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 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 4,000 individuals per year in the U.S.

In addition to writing the application, MED researchers can perform epidemiological 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 classification of a product as a drug, device, biological product, or combination product. The product’s designation as a combination or non-combination product will also determine which agency center of the FDA will have primary jurisdiction for regulation.

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 the FDA.

Marketing approvals

510(K)

A 510(k) is a submission to the FDA to demonstrate that the device to be marketed is substantially equivalent in terms of safety and effectiveness to a legally marketed device. This is also known as “premarket notification.”

Over the years, MED personnel have written or advised on dozens of 510(k) submissions in a wide variety of product areas.

PMA (PREMARKET APPROVAL)

A PMA application demonstrates the safety and effectiveness of a Class III medical device to the FDA.

MED Institute has supported over a dozen approved PMAs with strategy development, submission writing, communication with the FDA, and panel meeting support and management.

HDE (HUMANITARIAN DEVICE EXEMPTION)

This marketing application is similar to a premarket approval (PMA) application, but it doesn’t require a demonstration of the device’s effectiveness.

In the early ‘80s, MED Institute helped write the legislation for HDE regulation and helped a Cook Medical product receive the first HDE ever approved by the FDA.

NDA (NEW DRUG APPLICATION)

An NDA is an application to FDA demonstrating the safety and effectiveness of a new drug.

CER (CLINICAL EVIDENCE REPORT)

A CER is used to verify the clinical safety and performance of a medical device. It includes an assessment and analysis of clinical literature pertaining to the device, or similar devices. MED has written or assisted with over 100 CERs.

SHONIN

Shonin is a Japanese pre-market approval application that is submitted to the PMDA for higher-risk medical devices.

NINSHO

Ninsho is a pre-market certification application submitted to a registered certification body for marketing of a controlled medical device (Class II) in Japan.

Postapproval support

POSTAPPROVAL STUDY

Postapproval clinical studies are often required as a condition of approval of a PMA.

MED has experience designing studies for devices used across many clinical applications.

PUBLICATION SUPPORT

MED can assist with the editorial and technical aspects of writing manuscripts that report the results of clinical or non-clinical studies for peer-reviewed medical journals. We have assisted with over two dozen published articles, including co-authoring articles in such journals as the Journal of Vascular Surgery, the Journal of Urology, Gastrointestinal Endoscopy, and the European Journal of Vascular and Endovascular Surgery.

522 STUDY

522 studies are post-market surveillance studies that are sometimes required for certain already-approved devices. The FDA will typically require a 522 study if there are questions of specific concern involving the device.

The regulatory team at MED has designed several 522 studies and has managed correspondence with the FDA throughout the studies.

RECLASSIFICATION PETITION

The FDA, or any interested party, can request that all devices of a given type be reclassified (for example, from Class III to Class II). Such petitions involve summarizing the existing information on the device and demonstrating that the reclassification is warranted.

For more detailed information, please contact:

Justin Renfrow
Contracts Director
Dan Dillon
Senior Regulatory Scientist