Overview of Device Regulation | FDA
Overview of regulations: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling and reporting requirements.| U.S. Food and Drug Administration
Overview of regulations: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling and reporting requirements.| U.S. Food and Drug Administration
This guidance contains information for food facilities to determine what requirements to follow for their human food by-products for use as animal food.| U.S. Food and Drug Administration
The regulatory classes for medical devices that are based on the degree of control necessary to assure the various types of devices are safe and effective.| U.S. Food and Drug Administration
The main risks associated with CT scans are incidental results, leading to follow-up tests that may cause additional risks and the increased radiation exposure.| U.S. Food and Drug Administration
The FDA approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults.| U.S. Food and Drug Administration
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs on FDA Form 1572, Statement of Investigator| U.S. Food and Drug Administration
International Council on Harmonisation - Efficacy| U.S. Food and Drug Administration
FDA understands that when a drug is in shortage, patients and health care professionals may look to compounded drugs as an option to get their medication.| U.S. Food and Drug Administration
Hypoallergenic cosmetics are products that manufacturers claim produce fewer allergic reactions than other cosmetic products. Consumers with hypersensitive skin| U.S. Food and Drug Administration
The FDA granted supplemental approval to Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease| U.S. Food and Drug Administration
FDA’s investigation is complete. CDC declares outbreak over.| U.S. Food and Drug Administration
FDA’s investigation is complete. CDC declares outbreak over.| U.S. Food and Drug Administration
Starting January 1, 2023, sesame was added as the 9th major food allergen in the 2022 FDA Food Code.| U.S. Food and Drug Administration
This Summary provides a synopsis of the textual changes from the 2017 FDA Food Code and the Supplement to the 2017 Food Code Chapters and Annexes to the 2022 edition.| U.S. Food and Drug Administration
A Conversation on the FDA’s 2022 Food Code with Glenda Lewis & Andre Pierce| U.S. Food and Drug Administration
CORE Network strengthens FDA's efforts to prevent, detect, investigate, respond to, and learn from incidents and outbreaks.| U.S. Food and Drug Administration
Food safety and nutrition information for at-risk groups including pregnant women and older adults.| U.S. Food and Drug Administration
Certain foods – including ready-to-eat refrigerated foods, unpasteurized (raw) milk, and foods made with unpasteurized milk – often may be contaminated with a bacteria called Listeria, the third leading cause of death from food poisoning in the United States.| U.S. Food and Drug Administration
Questions and answers about the home-use test kit to measure human chorionic gonadotropin (hCG) in your urine, an indicator of pregnancy.| U.S. Food and Drug Administration
Dr. Stefano Luccioli shares his insights about the current food allergen landscape and emerging research that may change the way we think about, and live with, food allergies.| U.S. Food and Drug Administration
Food recalls, safety alerts and advisories, outbreak investigations, and keeping food safe in emergencies.| U.S. Food and Drug Administration
Educational fact sheets on food safety topics for consumers| U.S. Food and Drug Administration
FDA’s investigation is complete. CDC declares outbreak over.| U.S. Food and Drug Administration
Food Safety Tips for Consumers & Retailers During an Outbreak.| U.S. Food and Drug Administration
Food Safety Resources for Produce Shippers and Carriers During a Foodborne Illness Outbreak| U.S. Food and Drug Administration
Introduction to FDA's Whole Genome Sequencing (WGS) Program| U.S. Food and Drug Administration
Basic principles and application guidelines for Hazard Analysis and Critical Control Point (HACCP).| U.S. Food and Drug Administration
The FDA is sharing safety and regulatory information about phthalates in food packaging and food-contact applications.| U.S. Food and Drug Administration
The FDA is announcing its intention to extend the compliance date for the Food Traceability Rule by 30 months.| U.S. Food and Drug Administration
Resources for FDA compliance staff and news about enforcement action related to color additives.| U.S. Food and Drug Administration
FDA participates and exercises leadership in the Codex Alimentarius Commission.| U.S. Food and Drug Administration
FDA protects consumers from harmful exposure to chemicals in food that would have an adverse impact on human health.| U.S. Food and Drug Administration
FDA is advising home and commercial bakers to avoid using glitter and dust products to decorate cakes and other food items.| U.S. Food and Drug Administration
Food manufacturers are required to list all ingredients in the food.| U.S. Food and Drug Administration
FDA approved medications can help manage this disease that most commonly occurs in middle-aged and older dogs.| U.S. Food and Drug Administration
Comprehensive list of links to the UDI rule and guidances, training for industry, UDI and GUDID technical resources, and dockets.| U.S. Food and Drug Administration
This requires UDI data submitted to GUDID to be of a high quality such that all stakeholders in the healthcare community have sufficient confidence in the accuracy and completeness of that data. This will enable the GUDID to be a reference source of data used in downstream systems.| U.S. Food and Drug Administration
Device labelers have two options for submitting GUDID data: the GUDID web application and HL7 SPL file submission using the FDA Electronic Submission Gateway.| U.S. Food and Drug Administration
Nicotine keeps people using tobacco products, even when they want to stop. Learn more about nicotine and its effects from CTP.| U.S. Food and Drug Administration
This poster describes the common types of xylitol containing products and the most common symptoms of xylitol poisoning in dogs.| U.S. Food and Drug Administration
Guidance for Industry and FDA Staff - Humanitarian Use Device (HUD) Designations| U.S. Food and Drug Administration
Search the listing of Humanitarian Device Exemptions (HDEs) for medical devices.| U.S. Food and Drug Administration
FDA Plans to Phase Out Animal Testing Requirement| U.S. Food and Drug Administration
Un simple termómetro de refrigerador puede jugar un papel crucial.| U.S. Food and Drug Administration
For a MLMDs, effective transparency ensures that information that could impact patient risks and outcomes is communicated to all interacting with the device.| U.S. Food and Drug Administration
The Inspire UAS system is an implantable nerve stimulator to treat obstructive sleep apnea now indicated for use in people with greater AHI scores or greater BM| U.S. Food and Drug Administration
Información alimentaria para consumidores sobre alergias alimentarias, etiquetado de alimentos que contienen alérgenos alimentarios importantes, síntomas de una reacción alérgica y notificación de un problema con el etiquetado de un alimento.| U.S. Food and Drug Administration
Learn what foodborne illness is and how to prevent certain foodborne risks during your pregnancy.| U.S. Food and Drug Administration
Debe haber escuchado hablar en las noticias acerca de epidemias de enfermedades transmitidas por los alimentos, por ejemplo, causadas por la E. coli O157:H7 o Listeria monocytogenes.| U.S. Food and Drug Administration
Infórmese acerca de las enfermedades transmitidas por los alimentos y cómo prevenir determinados riesgos asociados con ellas durante el embarazo.| U.S. Food and Drug Administration
It is important to better understand and address how wiping and cleaning of food contact surfaces relates to the transfer of food allergens in retail.| U.S. Food and Drug Administration
Everything you need to conduct a food safety presentation for pregnant women.| U.S. Food and Drug Administration
Nutritionists recommend that everyone consume a balanced diet.| U.S. Food and Drug Administration
Happy holidays! This season of goodwill and giving thanks is also a festive celebration of food. Make this holiday feasting season a healthy one by keeping foods safe.| U.S. Food and Drug Administration
Protéjase y proteja a su familia siguiendo estos consejos de seguridad cuando prepare alimentos que contengan harina.| U.S. Food and Drug Administration
Eating raw (uncooked) flour, dough or batter could make you sick| U.S. Food and Drug Administration
Human gene therapy is the administration of genetic material to modify or manipulate the expression of a gene product or to alter the biological properties of living cells for therapeutic use.| U.S. Food and Drug Administration
FDA posted a shortage of the immediate release formulation of amphetamine mixed salts, commonly referred to by the brand name Adderall or Adderall IR.| U.S. Food and Drug Administration
FDA's current perspective on Bisphenol A used in food contact applications such as polycarbonate beverage bottles.| U.S. Food and Drug Administration
These resource pages are intended to explain some terms and concepts important for the evaluation of biocompatibility of medical devices| U.S. Food and Drug Administration
Questions and answers that have been raised by pet owners and veterinarians about FDA’s work looking into potential causes of non-hereditary canine DCM.| U.S. Food and Drug Administration
Reassessing the safety of food ingredients and substances as new, relevant data become available, is a key part of our food safety mission.| U.S. Food and Drug Administration
List of select chemicals in the food supply under FDA review| U.S. Food and Drug Administration
A Conversation Kristi Muldoon-Jacobs| U.S. Food and Drug Administration
To market a new color additive, a manufacturer must first request approval from FDA. This request is referred to as a Color Additive Petition.| U.S. Food and Drug Administration
Useful tools for consumers and health professionals to report problems (adverse reactions) with products that FDA regulates.| U.S. Food and Drug Administration
FD&C Act Chapter VII: General Authority| U.S. Food and Drug Administration
Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices| U.S. Food and Drug Administration
A color additive, as defined by regulation, is any dye, pigment, or other substance that can impart color to a food, drug, or cosmetic or to the human body.| U.S. Food and Drug Administration
Facts on the safety of color additives — dyes, or substances that can impart color when added or applied to a food, drug, cosmetic, or the human body| U.S. Food and Drug Administration
Transplantation of Non-Human Cells, Tissues or Organs Into a Human| U.S. Food and Drug Administration
Environmental Sampling is important because environmental contamination, and controls, may contribute to contamination of finished product.| U.S. Food and Drug Administration
Traumatic brain injury (TBI) can happen in a variety of situations. And everyone is at risk, especially children and older adults.| U.S. Food and Drug Administration
Tips for veterinarians to help them identify a legally marketed animal drug.| U.S. Food and Drug Administration
Drug compounding is the process of combining, mixing, or altering ingredients to create medication tailored to the needs of an animal or small group of animals.| U.S. Food and Drug Administration
CVM aims to increase awareness about veterinary medication errors and to educate veterinary professionals and the public about this important issue.| U.S. Food and Drug Administration
FDA makes adverse event reports related to animal drugs and devices used in animals available on openFDA.gov.| U.S. Food and Drug Administration
The Index is a list of animal drugs for use in minor species that have had their safety and effectiveness affirmed through an alternative FDA review process.| U.S. Food and Drug Administration
The Index is a list of animal drugs for use in minor species that have had their safety and effectiveness affirmed through an alternative FDA review process.| U.S. Food and Drug Administration
FDA has serious concerns about unapproved animal drugs. These drugs are not reviewed by FDA and may not meet FDA’s strict standards for safety & effectiveness.| U.S. Food and Drug Administration
FDA has regulatory oversight over devices intended for animal use and can take appropriate regulatory action if an animal device is misbranded or adulterated.| U.S. Food and Drug Administration
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals| U.S. Food and Drug Administration
La FDA aprobó la primera vacuna contra el COVID-19, que se comercializa ahora como Comirnaty (koe-mir'-na-tee), para la prevención de la enfermedad del COVID-19| U.S. Food and Drug Administration
FDA addresses the potentially dangerous effects of pure powdered caffeine.| U.S. Food and Drug Administration
Food Additives and GRAS Ingredients Information for Consumers| U.S. Food and Drug Administration
La cafeína puede ser parte de una dieta saludable para la mayoría de las personas, pero demasiada cafeína puede ser un peligro para la salud.| U.S. Food and Drug Administration
GMO foods have been available to consumers since the early 1990s. Since then, the FDA, EPA, and USDA have worked together to ensure that crops produced through genetic engineering for sale to consumers are safe for people, animals, and the environment.| U.S. Food and Drug Administration
Three federal agencies within the U.S. government work together to regulate most GMOs.| U.S. Food and Drug Administration
FDA Roundup: February 13, 2024| U.S. Food and Drug Administration
FDA Roundup: December 17, 2024| U.S. Food and Drug Administration
FDA has received reports of adverse events that may be related to overdoses due to dosing errors associated with compounded semaglutide| U.S. Food and Drug Administration
FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the pro| U.S. Food and Drug Administration
Low Acid Canned Food Regulation/Adulterated| U.S. Food and Drug Administration
The U.S. Food and Drug Administration has completed its evaluation of three generally recognized as safe (GRAS) notices for hemp seed-derived food ingredients.| U.S. Food and Drug Administration
Information about how FDA regulates food additives that are generally recognized as safe or "GRAS."| U.S. Food and Drug Administration
The final rule was published in September 2015 and larger animal food facilities were required to comply with the Current Good Manufacturing Practice (CGMP) requirements by September 2016.| U.S. Food and Drug Administration
