FDA 3147 2010 free printable template

REASON FOR REQUESTING VARIANCE Compliance with the limits of 21 CFR 1040. 11 c would restrict the intended use of the product because compliance would limit the output power to the extent that the desired effects would not be sufficiently visible Other or additional explanation Specify FORM FDA 3147 9/14 PREVIOUS EDITION IS OBSOLETE PSC Graphics 301 443-1090 EF PAGE 1 OF 4 PAGES 11.

How to fill out FDA 3147

How to fill out FDA 3147

1. Obtain the FDA Form 3147 from the FDA website or your local FDA office.
2. Provide the applicant's name and contact information at the top of the form.
3. Describe the device or product for which you are requesting a determination.
4. Indicate the intended use and indications for use of the device.
5. Fill out the section regarding the regulatory history of the device.
6. Include any supporting documentation, such as clinical data, if applicable.
7. Review the entire form for completeness and accuracy.
8. Submit the completed form and any attachments to the FDA through the specified channel.

Who needs FDA 3147?

1. Manufacturers seeking to determine the regulatory status of a device.
2. Companies planning to market a new medical device in the U.S.
3. Individuals or organizations involved in medical device research.

People Also Ask about

What is 21 CFR Part 210 and 211?

21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. 21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.

What is the meaning of 21 CFR?

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.

What is Part 21 of CFR?

(a) This part establishes procedures to implement the Privacy Act of 1974 (5 U.S.C. 552a). It applies to records about individuals that are maintained, collected, used, or disclosed by the Food and Drug Administration and contained in Privacy Act Record Systems.

What does CFR Title 21 cover?

The Code of Federal Regulations Title 21 contains the codified Federal laws and regulations that are in effect as of the date of the publication pertaining to food and drugs, both legal pharmaceuticals and illegal drugs.

What does 21 CFR Part 211 deal with?

(a) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals).

What is the FDA 21 CFR?

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government.

For pdfFiller’s FAQs

What is fda 3147 form?

The FDA Form 3147 is a document used by the Food and Drug Administration (FDA) in the United States. It is titled "Application for Determination of Compliance with Terms of Pediatric Exclusivity or Exemption" and is typically submitted by pharmaceutical companies. The form is related to the pediatric exclusivity program, which provides an additional period of exclusive marketing for certain drugs if the company conducts studies to assess their safety and effectiveness in children. The FDA Form 3147 is used to request a determination from the FDA regarding compliance with the requirements of pediatric exclusivity, potentially leading to an extension of the company's exclusive marketing rights.

Who is required to file fda 3147 form?

The FDA 3147 form is used for reporting information related to adverse events associated with medical products. The primary responsibility for filing this form lies with manufacturers, packers, distributors, and other initial distributors of the medical product. Healthcare professionals, consumers, and patients can also voluntarily submit adverse event reports using the FDA's MedWatch program.

How to fill out fda 3147 form?

To fill out FDA Form 3147, also known as the "MedWatch Consumer Voluntary Reporting Form," follow these steps: 1. Download the form: Visit the official FDA website or search for "FDA Form 3147" online. Download and open the form on your computer. 2. Provide basic information: Fill in your personal details in the "Patient Information" section, including your name, contact information, date of birth, and gender. 3. Describe the problem: In the "Describe the Problem" section, briefly explain the issue or problem you experienced with a specific product, medication, or medical device. 4. Describe the product: Provide details about the specific product involved in the "Product Information" section. Include the product's brand name, manufacturer, date of product use, and the reason for use. 5. Describe the event or problem: Explain in detail what happened or what problem you encountered in the "Describe the Event or Problem" section. Include the timeline, any symptoms experienced, and any medical intervention required. 6. Provide other relevant information: Fill out any additional sections that apply to your situation, such as "Healthcare Professional Information" (if applicable) and "Attachments" (for uploading any supporting documents, if necessary). 7. Consent and contact information: Read and agree to the "Authorization for Voluntary Reporting" section, providing your consent for the FDA to use and share the information you provide. Finally, complete the "Contact Information" section to ensure the FDA can reach out to you if needed. 8. Review and submission: Go through the form, double-checking for any errors or missing information. Once you are satisfied, save the completed form and submit it as instructed (either online or via mail, depending on the submission method provided). It is important to note that FDA 3147 is specifically for consumer voluntary reporting, so it may not be suitable for healthcare professionals or adverse event reporting related to clinical trials.

What is the purpose of fda 3147 form?

The FDA Form 3147, also known as the Drug Evaluation Staff Monthly Status Report, is used by the U.S. Food and Drug Administration (FDA) to track the progress of new drug applications (NDAs) and supplemental applications for drugs that have already been approved. This form helps the FDA to maintain an organized record of the regulatory process and facilitates communication between the FDA and the drug manufacturers. It provides an overview of the drug development process, including information such as the status of the application, key milestones, current challenges, and any regulatory actions taken by the FDA. The purpose of the FDA Form 3147 is to ensure transparency and efficiency in the drug approval process and to aid in decision-making regarding the evaluation and approval of new drugs.

What information must be reported on fda 3147 form?

The FDA 3147 form, also known as the "MedWatch Form," is used to report adverse events, product defects, or other safety concerns related to drugs, biologics, medical devices, dietary supplements, or cosmetics to the U.S. Food and Drug Administration (FDA). The required information on the form includes: 1. Patient Information: Demographic details of the patient experiencing the adverse event, such as age, gender, weight, and relevant medical history. 2. Reporter Information: Contact information and occupation of the person reporting the event, which can be a healthcare professional, patient, consumer, or representative. 3. Adverse Event: Details regarding the adverse event, including the date of the incident, symptoms experienced, severity, and outcome (e.g., hospitalization, disability, death). 4. Suspect Product: Information about the specific product involved, such as the brand name, manufacturer, lot number, expiration date, and product description. 5. Concomitant Medications: Any other medications, treatments, or therapies the patient was concurrently using at the time of the adverse event. 6. Patient Outcome: Follow-up information regarding the patient's health after the event, such as additional treatments, hospitalizations, or changes in the condition. 7. Reporter's Comments: Any additional relevant information or comments that may aid in the investigation of the adverse event. It is essential to provide accurate and detailed information to ensure effective evaluation and potential regulatory action by the FDA.

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What is FDA 3147?

FDA 3147 is a form used by the Food and Drug Administration (FDA) for the voluntary reporting of adverse events and product problems associated with the use of medical devices.

Who is required to file FDA 3147?

FDA 3147 must be filed by medical device manufacturers, importers, and healthcare professionals who encounter adverse events or product problems related to medical devices.

How to fill out FDA 3147?

To fill out FDA 3147, one should provide detailed information regarding the adverse event or product problem, including patient demographics, device identification, event description, and any related clinical information.

What is the purpose of FDA 3147?

The purpose of FDA 3147 is to collect and analyze information on adverse events and product issues to enhance the safety and effectiveness of medical devices in the market.

What information must be reported on FDA 3147?

The information that must be reported on FDA 3147 includes patient information, device details, a description of the adverse event, the outcome, and any actions taken regarding the device.