FDA Review checklist

The FDA Review Checklists can be used by your internal QA team to self-regulate. Acting as FDA reviewers, they can confirm that your submission conforms to all format, content, and support requirements. And, of course, should the QA team find a weakness, you can correct and rereview prior to actual submission. 

Each of the submission documents described in this book includes two checklists. The first is a checklist intended to assist in the preparation of the document it outlines the requirements, organizational structure, and format. The second is a checklist derived from the FDA s review and guidance documents, discussions with FDA reviewers, and with professionals experienced in the development of type submissions. It is intended to be a checklist that might be used by the FDA reviewer of the final submissions document (in many cases, these checklists have been adopted by FDA personnel and are in actual use). 

This FDA Orphan-Drug Review checklist has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Office of Orphan-Drug Development to critique and assess applications received. It can be used internally as a part of the Quality Assurance process, as a guideline for regulatory development of an application, and/or as a self-assessment tool to predict likely FDA response to an application. 

The. .. program has undergone six code modifications. Each of these code modifications was implemented after a Software and Test Case Review Checklist was completed. .. However, none of these six code reviews detected the. .. problem. .. which led to the current recall. [FDA Warning Letter, 1998]... 

But that sense of control can be regained and the result made rational and predictable through a careful QA process that checks the submission against FDA established criteria and through the use of an internal, self-regulating review process that applies the checklist criteria used by the FDA to the submission development process. 

Perhaps uniquely, the FDA has developed and distributed its own checklist for meeting requests, used internally to evaluate requests when they are received. Presumably, this unusual inclusion is a result of the relatively mundane—administrative only—review. The checklist can be found in the second FDA document included here How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVM — Checklist. ... 

This checklist is intended for use in the preparation and submission of Meeting Requests. It is recommended that, prior to transmission to the FDA, a second internal review be conducted by an individual or department not involved (presumably Quality Assurance) in the preparation of the submission. 

As soon as the final IND is completed, it is submitted (see the checklist). The FDA conducts a formal review (response generally issued within 30 days of submission). That response (generally provided in a conference call) may be full approval with permission to conduct the proposed study of studies, approval with some restriction on the proposed study or studies, or a rejection. Each requires a response from the submitter. 

The FDA s Office of Device Evaluation, Center for Devices and Radiological Health, has developed a number of information sheets and guidance policies to help sponsors conduct clinical trials. IDE Memorandum D94-1 is particularly helpful. It contains an IDE Checklist for Administrative Review that sponsors can use to ensure that their IDE is administratively complete. Another important document is entitled Implementation of the FDA/ HCFA Intragency Agreement Regarding Reimbursement Categorization of Investigational Devices—IDE Memorandum D95-2. This memo establishes procedures... 

The European Union Medical Device Directive (and various other national systems) has adopted a review scheme known as the Essential Requirements Checklist. The manufacturer must meet the essential requirements of the Directive, which is a standardized grouping of attributes for medical products. All devices, regardless of classification or conformity assessment route, must prove that the product meets the essential requirements. Where a harmonized standard exists for the product, and the product meets the standard, it is deemed to automatically meet the essential requirements, but for biotextUes, these are few and far between. One notable device-specific standard for a biotextile vascular graft is ISO 7198 First edition 1998-08-01 Cardiovascular implants - Tubular vascular prostheses, which is recognized by FDA. 

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