Regulatory Solutions

Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices Guidance for Industry and Food and Drug Administration Staff

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This guidance document provides recommendations for 510(k) submissions for ultrasonic diathermy devices, also known as physiotherapy devices. Ultrasonic diathermy devices are devices under section 201(h) of the Federal Food, Drug and Cosmetic Act (the FD&C Act). This guidance includes recommendations on the use of certain International Electrotechnical Commission (IEC) standards in generating information that can ... Read more Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices Guidance for Industry and Food and Drug Administration Staff

Assembler’s Guide to Diagnostic X-Ray Equipment Guidance for Industry and Food and Drug Administration Staff

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The Center for Devices and Radiological Health (CDRH) is charged with the responsibility for enforcing regulations created under the Radiation Control for Health and Safety Act of 1968 (Public Law 90-602) (the Act). The Act was later moved to the Federal Food, Drug, and Cosmetic Act (FD&C Act) with the passage of the Safe Medical ... Read more Assembler’s Guide to Diagnostic X-Ray Equipment Guidance for Industry and Food and Drug Administration Staff

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry

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This guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).2 Specifically, this guidance ... Read more Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry

“Medical X-Ray Imaging Devices Conformance with IEC Standards Guidance for Industry and Food and Drug Administration Staff”

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This guidance describes FDA’s policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDA’s regulations that apply to medical devices and electronic products. In this guidance, FDA is seeking to harmonize performance standards prescribed pursuant to section 534 of Subchapter C ... Read more “Medical X-Ray Imaging Devices Conformance with IEC Standards Guidance for Industry and Food and Drug Administration Staff”

“Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry”

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INTRODUCTION (1)2 A. Objective (1.1) This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing International Council for Harmonization (ICH) Quality guidances, this guidance provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and ... Read more “Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry”

“Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment Guidance for Industry”

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This guidance is intended to provide recommendations to sponsors regarding eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and to foster greater efficiency in development programs for drugs for the treatment of neovascular age-related macular degeneration. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances ... Read more “Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment Guidance for Industry”

Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry

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INTRODUCTION (1)2 A. Objective (1.1) This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing International Council for Harmonization (ICH) Quality guidances, this guidance provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and ... Read more Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry

Drug or Device – Who regulates your product?

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The very first step towards bringing your product to the market is understanding which center at the FDA shall regulate your product. The primary centers at the FDA are: CDRH – Center for Devices and Radiological Health CDER – Center for Drug Evaluation and Research CBER – Center for Biologics Evaluation and Research Although, FDA … Read more Drug or Device – Who regulates your product?

Nutraceuticals

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INTRODUCTION Nutraceuticals is a broad umbrella term that is used to describe any product derived from food sources with extra health benefits in addition to the basic nutritional value found in foods. The term “nutraceutical” combines two words – “Nutrient” (a nourishing food component) and “pharmaceutical” (a medical drug). The name was coined in 1989 … Read more Nutraceuticals

CER Requirements and Expertise

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According to MEDDEV 2.7/1 Rev.4, “Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to analyse whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s instructions for ... Read more CER Requirements and Expertise