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Noise Claims in Hearing Aid Labeling - Guidance for Industry
… the guidance you are requesting. Noise Claims In Hearing Aid Labeling Manufacturers who make noise claims in their labeling for hearing aids (e.g. improved speech understanding in noisy … Modernization Act (FDAMA) of 1997, air conduction hearing aids are exempt from premarket notification subject …
The Open Public Hearing at FDA Advisory Committee Meetings
… ensuring FDA has access to such advice through the public hearing process as provided in existing laws and regulations. … Every advisory committee meeting includes an open public hearing (OPH) session, during which interested persons may … of the Commissioner … Guidance Document … The Open Public Hearing at FDA Advisory Committee Meetings: Guidance for the …
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
… Federal Food, Drug, and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification products (PSAPs). A lack of clarity between PSAPs and hearing aids has contributed to stakeholder and consumer confusion. This guidance is intended to describe hearing aids, PSAPs, their respective intended uses, and the …
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act
… also outlines the procedures for an administrative hearing (hearing) related to a final order. Finally, this guidance …
Guidance for Industry: Dear Manufacturer Letter Regarding Front-of-Package Symbols
… highlight several nutrients. In 2007, FDA held a public hearing to solicit information about the criteria used for … FDA is evaluating the information presented as part of the hearing docket. A webcast of the hearing is currently available. While the agency continues to …
CPG Sec. 140.100 Seizure of Books that Constitute Misleading Labeling
… by section 304 of the Act to seize without a prior hearing may be argued to be an unconstitutional prior … *against the product and an injunction to halt, after a hearing, the misuse of the book.* *Material between asterisks …
CPG Sec. 160.100 Regulatory Actions and Small Business
… petitions to the Agency. Providing information on Agency hearing procedures and how small businesses can participate …
CPG Sec 560.500 Jams, Jellies and Related Products - Imports
… not available. After detention, the importer may request a hearing. If he can demonstrate by acceptable evidence that …
CPG Sec 550.550 Maraschino Cherries
… colored and flavored. Later, evidence submitted at the hearing held in April 1939 for the purpose of establishing a …
Center for Devices and Radiological Health (CDRH) Appeals Processes
CPG Sec 585.850 Sweet Potatoes - Sirup Pack
… of fact, conclusion, and final order (resulting from a hearing) were silent concerning this practice. Following …
CPG Sec 550.475 Jellies, Nonstandardized
… do not purport to be standardized articles. The record of hearing and findings of fact which form the basis for the …
Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon
… More on AquAdvantage Salmon Background on the Public Hearing on the Labeling of Food Made from the AquAdvantage …
Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
… square (rms) sound pressure level greater than 99 dBA with hearing protection in place. These criteria apply only to …
Emergency Use of an Investigational Drug or Biologic
… include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke. Institutional procedures may …
Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979
… FOR DISQUALIFICATION 58.204 NOTICE OF AND OPPORTUNITY FOR HEARING ON PROPOSED DISQUALIFICATION 58.206 FINAL ORDER ON … and affording affected parties an opportunity for a public hearing on the matter. If a hearing is requested, affected parties will have the …
Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process
Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations
… led to the referral Summary of public comments Open public hearing Presentation of questions Expert panel discussion …