Navigating the FDA Website and Other Resources

Apr 21

Have you ever wondered… “What does the FDA think about [blank]”?

If you’re new to the industry or in an industry regulated by the Food and Drug Administration (FDA), understanding the tools and resources provided by the FDA will help you understand and meet the FDA’s expectations as well as stay compliant. The FDA’s website provides a plethora of resources but knowing where to find things can be daunting. The following areas are regulated by the FDA: Food, Drugs, Medical Devices, Radiation-Emitting Products, Vaccines/Blood/and Biologics, Animal and Veterinary, Cosmetics, and Tobacco Products [1] .

The Office of the Federal Register (OFR) publishes the Federal Register 2 which contains federal agency regulations, proposed rules and notices of interest to the public, executive orders, proclamations, and other presidential documents [3] . Why does this matter? Those who are in businesses regulated by the FDA should understand proposed rules including petitions for policy making, and rules and regulations that impact their scope of business. Documents published in the Federal Register as rules and proposed rules include citations to the Code of Federal Regulations (CFR) to refer readers to the CFR parts affected. The CFR contains the complete and official text of agency regulations organized into fifty titles covering broad subject areas [2] .

For this blog, we’ll focus on a few main areas, here is an overview on navigating the FDA’s website and a few other resources for those in the cellular and biologics space, tissue, medical devices, and drugs (pharma), starting with FDA’s website: https://www.fda.gov/ [1] . Once in the FDA’s website, a quick keyword search in the search bar will query all items published and available by the FDA.

Vaccines, Blood & Biologics ( https://www.fda.gov/vaccines-blood-biologics [4] )

This page provides resources to companies in the areas of (clicking on the link will take you to the site): Allergenics [5] , Blood & Blood Products [6] , Cellular & Gene Therapy Products [7] , Guidance, Compliance & Regulatory Information (Biologics) [8] , Tissue & Tissue Products [9] , Vaccines [10] , Xenotransplantation [11] , Development & Approval Process (Center for Biologics Evaluation and Research – CBER) [12] , Safety & Availability (Biologics) [13] , International Activities [14] , Science & Research (Biologics) [15] , News & Events [16] , Fecal Microbiota Products [17] , and the Center for Biologics Evaluation and Research (CBER) [18] .

Each page provides information for the related type of products or therapies such as regulatory information, donor eligibility determination requirements, compliance and surveillance, labeling, forms, establishment registration, product listings, good “X” practices (where “X” may be for tissue, clinical, manufacturing, laboratory etc.), safety, and reporting.

Medical Devices (https://www.fda.gov/medical-devices) [19] This page provides multiple resources for medical device manufacturers from registering your establishment, submissions for premarket devices, guidance documents, recalls and more. This area falls under the Center for Devices and Radiological Health (CDRH), more information can be found here at CDRH [20] .

Drugs (https://www.fda.gov/drugs) [21]

This site provides resources for the lifecycle of drugs, from development to manufacturing, submissions and compliance. This area falls under the Center for Drug Evaluation and Research (CDER), CDER regulates over the counter and prescription drugs, including biological therapeutics and generic drugs. More information can be found here at their site here CDER [22] .

Looking to qualify vendors or partnerships and want to better understand which regulation impacts them? The following are pages to find Establishment Registrations for:

Medical Device Establishments:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm [23]

Human Cell and Tissue Establishments (HCTPS):

https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/tiss/index.cfm [24]

Drug Establishments:

https://dps.fda.gov/decrs [25]

Blood Establishments:

https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/ [26]

For those who must perform Infectious Disease testing, here’s where to find the licensed, cleared, and approved FDA test kits:

https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/testing-human-cells-tissues-and-cellular-and-tissue-based-product-hctp-donors-relevant-communicable [27]

Other Resources:

1. I’d like to learn more about different quality systems. Where do I find the Code of Federal Regulations for the Federal Register (electronic version) that provides guidance to these systems?

https://www.ecfr.gov/ [28]

Quick links for the following CFR areas:
- Biological Products: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F [29]
- Medical Device Products: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H [30]
- Drug Products: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C [31]
- Drugs for Human Use: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D [32]
- Human Cells, Tissues, and Cellular and Tissue-Based Products: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271 [33]

2. For laboratory testing, where do I find the Clinical Laboratory Improvement Amendments (CLIA) license information for certain laboratories? Follow this link: https://qcor.cms.gov/main.jsp [34]

Once on this page, click “CLIA Laboratory Lookup”
Type in the identifying information or key words under the “Facility Name”, if the “CLIA Identification Number” is available, enter this, or enter the “CLIA Lab Director”, and click “Search”
Results will appear based on the information entered

Multiple resources are available throughout the FDA’s website, reach out and let us know if you need help! Did you know the Centers for Disease Control and Prevention (CDC) has a global presence in over sixty (60) countries? Check back for a later blog on navigating the CDC’s website and how this resource impacts our industry!

Resources and Links:

[1] https://www.fda.gov/

[2] https://www.federalregister.gov/

[3] https://www.archives.gov/federal-register/the-federal-register/about.html

[4] https://www.fda.gov/vaccines-blood-biologics

[5] https://www.fda.gov/vaccines-blood-biologics/allergenics

[6] https://www.fda.gov/vaccines-blood-biologics/blood-blood-products

[7] https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products

[8] https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics

[9] https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products

[10] https://www.fda.gov/vaccines-blood-biologics/vaccines

[11] https://www.fda.gov/vaccines-blood-biologics/xenotransplantation