Medical Device FDA Guidances

The FDA regulates medical devices sold in the United States to assure their safety and effectiveness. Depending on the device classification, along with other factors, federal regulations, such as the Code of Federal Regulations, Title 21, define requirements that must be fulfilled for CDRH to approve or clear devices sold in the United States.

eCTD Format
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Providing Regulatory Submissions for Medical Devices in Electronic Format (2020) FDA This document provides guidance on FDA’s interpretation of the statutory requirement for submission and pre-submission of medical devices in electronic format; this document also contains guidance on additional submission types for which submission in electronic format is anticipated to be recommended. English Complimentary
Meetings with the FDA
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Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program FDA The purpose of this guidance is to provide an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with the Food and Drug Administration (FDA) regarding potential or planned medical device Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW), Dual 510(k) and CLIA Waiver by Application Submissions (Duals), Accessory Classification Requests, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act). English Complimentary
Types of Communication During the Review of Medical Device Submission (2014) FDA During the review of a premarket submission, FDA’s practice has been to communicate with applicants through either a formal communication (such as a Major Deficiency Letter or an additional information request issued through a letter, or through phone, fax, or email, with a follow-up letter confirming the hold) or through the process of Interactive Review. English Complimentary
Premarket Application (PMA)
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Acceptance and Filing Review for PMAs FDA The PMA regulation (21 CFR 814.42(e)) identifies the criteria that, if not met, may serve as a basis for refusing to file a PMA. This guidance is intended to be used by FDA staff and the device industry to help elucidate the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process. English Complimentary
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510(k)-Review-Program (2020) FDA The 510(k) Third Party (3P510k) Review Program (formally known as the Accredited Persons (AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act.1 Under this authority, FDA recognizes third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices. English Complimentary

GRP White Paper: How Medical Devices are Classified by the FDA.

FDA defines a medical device as any product that does not achieve its purposes by chemical action or metabolization. Correctly classifying a medical device is crucial for outlining the regulatory requirements and standard that it need to comply to and the regulatory strategy for its registration with FDA.

FDA Substantial Equivalence Predicate Device

GRP WhitePaper: How the FDA defines Substantial Equivalence to Predicate Device

The concept of substantial equivalence of medical devices was introduced by the US Food and Drug Administration (FDA) as part of the Medical Devices Amendment (MDA) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) enacted on May 28, 1976.

510k Premarket Notification

GRP White Paper: 510(k) Premarket Notification

A 510(K) is a pre-market submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective and substantially equivalent, to a legally marketed device .