United States’ FDA
Medical Device/IVD
Pharmaceuticals
Cosmetics
Food Supplements
Medical Devices
USA Medical Device Regulations:
In the United states the Food and Drug Administration (FDA) regulates the sale of medical devices. The main regulation that defines the requirements of market authorization in the US is the Federal regulations (such as the Code of Federal Regulations, Title 21. and the Federal Food Drug & Cosmetic Act.
GRP-USA Medical Device Services:
Global Regulatory Partners Inc. (GRP), can help you navigate the complex regulatory landscape of the FDA. Our teams of regulatory affairs, clinical, quality and pharmacovigilance experts can collect the regularly intelligence develop the appropriate regulatory strategy and register successfully your medical device or IVD with FDA.
Authorized local agent
The US Food and Drug Administration (FDA) requires all foreign medical device and IVDs manufacturers who intend to register and sell their products in the United States of America (USA) to appoint and retain a US Agent with a physical address within the USA territory. Global Regulatory Partners, Inc., (GRP) can act as your US agent with FDA .
GRP Services in USA:
- Communication with the FDA
- Assistance with FDA inspection
- Adverse Effects Reporting ( 21 CFR 803 Medical Device Reporting (MDR) regulations)
- Establishment registration and products’ listing with FDA ( FDA Unified Registration and Listing System (FURLS)).
- Annual Reporting.
- Products’ Registration.
- Organization of consultation meetings with FDA
Regulatory intelligence
Global regulatory Partner, Inc. (GRP) provides a full spectrum of regulatory affairs services, that cover all medical devices and IVD’s lifecycle. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.
GRP’s regulatory affairs services :
- regulatory intelligence,
- regulatory strategy,
- regulatory operations,
- and publishing; product registration,
- registration amendments;
- consulting meetings with regulatory authorities.
Regulatory intelligence (RI) is an essential tool for regulatory professionals, as it allows them to collect the required information related to a product, analyze it and use it to develop the appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.
Due to the continuous change of the regulatory environment, it is becoming more challenging for regulatory professionals to stay up to date of the latest regulatory requirements than can impact their products’ registration with FDA and access the US market.
Global Regulatory Partners Inc., (GRP) has a team of professionals who have the tools and expertise to collect a tailored Regulatory Intelligence for your product that includes not only the collection and analysis of all regulations that are applicable to your product but also information on similar products on US market, to allow you develop the best regulatory strategy to develop, register and commercialize your products in US market.
As the US Food and Drug Administration (FDA) regulatory requirements for medical devices and IVDs keep evolving, partnering with experienced FDA consultants, such as Global Regulatory Partners Inc., regulatory affairs team can help you develop the appropriate regulatory strategy for the development, registration and commercialization of your product in US market in compliance with FDA requirements.
GRP regulatory affairs team has developed many regulatory strategies for medical device and IVD products from different therapeutic areas, that allowed medical device companies to forecast with confidence their key milestones, develop and register their products successfully with FDA and meet their business goals.
In developing the regulatory strategy, GRP team takes into consideration different parameters such as:
- information on competitors,
- product’s development status and milestones,
- business goals, timelines,
- applicable regulatory requirements, operating costs,
- and the assessment of potential risks that may occur during product’s development, registration or commercialization.
Medical Writing is an important function of regulatory affairs. It consists of writing scientific, technical documents and reports of different types which include regulatory and research-related information, disease or drug-related educational and promotional literature.
FDA expects to receive precise, clear and well-written technical and regulatory documents from pharmaceutical and biologic companies. Any bad writing can raise FDA queries and consequently can delay the FDA products’ review process and approval.
Global Regulatory Partners Inc, (GRP) medical writers have the expertise in presenting the collected scientific information in a suitable way so it can be understood by different target audience, namely, FDA, patients or general public, physicians or the regulators. GRP Medical writers understand the medical concepts and terminology, knowledge of relevant FDA guidelines as regards to the structure and contents of specific documents, and good writing skills.
Product registration
US FDA classifies medical devices and IVDs in three (3) classes based on the level of control necessary to assure their safety and effectiveness. Additionally, medical device/IVDs classification is risk based, that is, the risk the device poses to the patient and/or the user. Class I includes devices/IVDs with the lowest risk and Class III includes those with the greatest risk. The registration process of medical devices and IVDs with the FDA depends on their classification as summarized below.
The consultation meetings with FDA for medical devices and IVDs are called “Pre-sub meetings” or “Q-Sub meetings”. These meetings allow sponsors and manufacturers to obtain FDA feedback and input on various regulatory and clinical questions related to their medical devices or IVDs, such device design as Investigational Device Exemptions (IDE) necessary for high-risk medical device clinical investigations, 510(k) submissions, and clinical or non-clinical study protocols.
The FDA Pre-sub programs are useful for devices with novel technologies, or those with indications that qualify them as “first of a kind” devices. Pre-sub meetings with FDA can be face-to-face meetings or via teleconferences with appropriate FDA personnel, or simply a written feedback.
Although Pre-Sub meeting submissions are not mandatory, medical device and IVD manufacturers are highly encouraged to do so to receive early feedback and ensure better quality of their regulatory submissions to the FDA. Global Regulatory Partners, Inc., (GRP) Regulatory affairs team has prepared and attended many Sub-Q meeting with FDA for different medical devices and IVDs USA.
Manufacturers wishing to introduce Class II medical devices /IVDs (and a small number of Class I and III devices) to the US market must first submit a 510(k) (Premarket Notification) to the FDA and receive FDA clearance. A 510(k) is also required for manufacturers changing the intended use of their medical device /IVD or changing the technology of a cleared medical device/IVD in such a way that it may significantly affect its safety and/ or effectiveness.
There are 4 types of 510(K): Traditional 510(K), Abbreviated 510(K), Special 510(K), DeNovo. To learn more about the different types of 510(K) check our white paper on “510(k) Pre-market Notification”
Global Regulatory Partners, Inc., (GRP) Regulatory affairs team had prepared, submitted and cleared with FDA many 510(K)s for multiple Class II medical devices and IVDs in USA.
Registration of Class III devices: Premarket applications PMA
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices.
Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance. There are three types of PMA: Traditional, Modular, Streamlined.
Medical Writing is an important function of regulatory affairs. It consists of writing scientific, technical documents and reports of different types which include regulatory and research-related information, disease or drug-related educational and promotional literature.
FDA expects to receive precise, clear and well-written technical and regulatory documents from pharmaceutical and biologic companies. Any bad writing can raise FDA queries and consequently can delay the FDA products’ review process and approval.
Global Regulatory Partners Inc, (GRP) medical writers have the expertise in presenting the collected scientific information in a suitable way so it can be understood by different target audience, namely, FDA, patients or general public, physicians or the regulators. GRP Medical writers understand the medical concepts and terminology, knowledge of relevant FDA guidelines as regards to the structure and contents of specific documents, and good writing skills.
| Device Classification | Risk Category | Regulatory Controls-Registration Process |
|---|---|---|
| Class I | Low risk |
General Controls
|
| Class II | Medium risk |
General Controls and Special Controls
|
| Class III | High risk | General Controls and Premarket Approval (PMA) |
GRP whitepaper: 510(k) Premarket Notification
A 510(K) is a pre-market submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective and substantially equivalent to a legally marketed device.
GRP Whitepapers: Formal meeting with the FDA
FDA encourages sponsors to consult the agency during their products’ development program through one of its 3 types of formal meeting (Type A, Type-B and Type-C). Each meeting has its own purpose and process.
Clinical
Global Regulatory Partners, Inc., (GRP) clinical team apply our therapeutic, regulatory, and operational expertise to consistently make sure that your clinical studies are conducted with ICH guidelines and other applicable regulatory requirements. In an increasingly challenging environment, our clinical team has the experience and knowledge to find, recruit, and retain patients in clinical trials and successfully deliver access to the appropriate sites and patients.
Global Regulatory Partners, Inc., (GRP) clinical team has managed many clinical studies for different medical devices and IVDs in USA in line with GCP and FDA requirements.
GRP clinical services include:
- Protocol development
- Clinical operations
- Sites’ and investigators’ identification, qualification and selection
- Site initiation and training
- Clinical monitoring
- Medical monitoring
- Statistical analysis
- Electronic Trial Master File
- Full-service data management
- gov registration and management
- Clinical site quality and GCP audits
Quality Services
The US Food and Drug Administration requires manufacturers, specification developers, contract manufacturers, and relabels/preprocessor, and even some distributors must implement a quality system that meets the Quality System Regulation (QSR) for medical devices found in 21 CFR Part 820. The QSR is similar to ISO 13485 standard for quality management systems, but not the same.
As part of your full or partial QMS audits, monitoring your critical suppliers is both good business practice and a regulatory requirement. It is your responsibility to ensure proper manufacturing processes even if you rely on subcontractors for components of your manufacturing operations. GRP certified quality auditors can conduct quality audits to your main and critical suppliers to assess their compliance to QMS requirements and your products requirements.
FDA regulations require manufacturers to conduct regular internal audits of their quality management systems. GRP provides internal auditing services which allow for an independent review of your full quality system. We can also conduct specific QSR process audits in which we focus on specific areas of the quality system where you suspect non-compliance occurs or has occurred or focus on areas where conflicts of interest make an outside, independent GMP audit desirable.
GRP certified quality auditors can perform gap analysis audits to your manufacturing sites to evaluate your current level of compliance with Quality System Management requirements as per FDA regulation 21 CFR Part 820 and ISO 13485. Gap analysis quality audits can be conducted at any time during your medical devices/IVDs lifecycle. Their main goal is to identify quality deficiencies beforehand to be able to correct them in time, before any FDA inspection or after recalls.
A pre-production QMS is ideal for medical device manufacturers that are 18-24 months away from commercialization and distribution. The benefit for this approach is to allow the organization to build and improve their quality system as they proceed through design and development, validation testing, conducting clinical trials, and eventually market launch.
The US Food and Drug Administration (FDA) and other market regulators including COFEPRIS require proof of compliance with established design control procedures for some device classifications. It is important to show ongoing compliance all the way from device conception through release to market.
To ensure ongoing compliance with quality system procedures, you should;
- evaluate your pre-production QMS using internal audits at least once a year.
- Conducting periodic internal audits also supports the evolution of the QMS when new processes are added to the system as the organization approaches launch of the product.
GRP certified quality auditors can conduct a QSR or QMS mock-up audits that mimic FDA inspections. These types of audits will help you prepare for FDA inspections and can be surprise audits as well to mimic real surprise FDA inspections. The FDA QSR /ISO 13485 mock-up audits are performed using the FDA’s Quality System Inspection Technique (QSIT) to prepare an organization for actual FDA inspections especially after PMA submission or after a serious recall.
GRP can conduct a gap or internal audit in anticipation of an FDA inspection or even assist during an actual FDA inspection. GRP can assist you in identifying any problem areas of your quality system prior to an FDA inspection. This type of FDA audit is similar to a gap audit, but we focus on any areas that may be reviewed more intently by an FDA Investigator, e.g. complaint handling, design control, corrective action, manufacturing processes, special processes, etc.
The FDA does not perform a pre-registration audit for Class I and II device manufacturers; however, it performs a QMS audit prior Class III registration. Additionally, FDA conducts pre-announced inspections to medical device manufacturers to ensure their compliance to quality system requirements.
Even though FDA doesn’t require a pre-registration audit for Class I and Class II devices, companies are required by law to be following the applicable sections of the QSR before placing their device on the market. If the FDA inspect their facility and found it not in compliance, they may issue a Form 483.
Medical device companies must conduct regularly internal audits to monitor their quality management system and ensure it stays in compliance with FDA QSR requirements.
As an experienced consulting firm, GRP has helped many medical device companies comply with FDA 21 CFR Part 820 and ISO 13485 Quality Management Systems (QMS). Additionally, GRP can customize the FDA QSR quality management system to meet the client’s business needs. As its quality team doesn’t use “off the shelf” QMS solutions or QMS packaged software but create a tailored QMS for each customer that meets its business needs and complies with FDA QSR as well.
To know more, please check out our white papers
FDA Whitepapers:
Establishment Registration and Device listing
US FDA’s Pre-Approval Inspections
Pharmaceuticals
FDA Drug Definition:
Drug are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
FDA Biologic Definition:
Biological products replicate natural substances and can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. Biologics are made from a variety of natural resources—human, animal, and microorganism—and may be produced by biotechnology methods.
Diagnostic Radiopharmaceutical Definition:
The FDA defines a diagnostic radiopharmaceutical as a :
(a) An article that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans and that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or
(b) Any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of such article as defined in paragraph (a) of this section.
GRP Pharmaceutical Services:
Global Regulatory Partners, Inc., (GRP), provides a full spectrum of regulatory affairs, clinical and quality services to pharmaceutical and biologic companies to allow them to develop and register their products in USA in line with FDA regulations and guidelines. GRP regulatory services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management. With offices in USA, GRP -USA can act as your US Agent with FDA as well.
Authorized local agent /US Agent
The US Food and Drug Administration requires foreign manufacturers who intends to register and sell their products in the United States of America (USA), to retain a US Agent with a physical address within the United States of America territory.
- Assistance with FDA inspection
- Adverse Effects Reporting
- Establishment registration and product listing ( FDA Unified Registration and Listing System (FURLS)).
- Annual Reporting.
- Products’ Registration.
- Organization of FDA consultation meetings.
In USA, GRP-US is licensed to act as your US Agent and can provide the following services: Communication with the FDA
GRP Whitepapers: US Representatives
The FDA requires any foreign establishment to appoint a United States agent ( U.S. agent ) for that establishment.
Regulatory intelligence
Global Regulatory Partner, Inc., (GRP) provides a full spectrum of FDA regulatory affairs services to Pharmaceutical and Biologic companies that cover the whole products’ lifecycle, starting from the development phase and going through clinical and registration phases till commercialization.
GRP regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, consultation meeting with FDA (Pre-IND, Pre-NDA), product’s registration (NDA, IND), medical writing, products’ life cycle management and maintenance. Our Regulatory affairs teams helped many pharmaceutical and biologic companies understand and efficiently manage the demanding complexity of develop, register and commercialize their products successfully in US market and in line with FDA regulatory requirements.
Regulatory intelligence (RI) is an essential tool for regulatory professionals, as it allows them to collect the required information related to a product, analyze it and use it to develop the appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.
Due to the continuous change of the regulatory environment, it is becoming more challenging for regulatory professionals to stay up to date of the latest regulatory requirements than can impact their products’ registration with FDA and access the US market.
Global Regulatory Partners Inc., (GRP) has a team of professionals who have the tools and expertise to collect a tailored Regulatory Intelligence for your product that includes not only the collection and analysis of all regulations that are applicable to your product but also information on similar products on US market, to allow you develop the best regulatory strategy to develop, register and commercialize your products in US market.
As the US Food and Drug Administration (FDA) regulatory requirements for pharmaceutical and biologic products keep evolving, partnering with experienced FDA consultants, such as Global Regulatory Partners Inc., regulatory affairs team can help you develop the appropriate regulatory strategy for the development, registration and commercialization of your product in US market in compliance with FDA requirements.
In developing the regulatory strategy, GRP team takes into consideration different parameters such as information on competitors, product’s development status and milestones, business goals, timelines, applicable regulatory requirements, operating costs, and the assessment of potential risks that may occur during product’s development, registration or commercialization.
GRP regulatory affairs team has developed many regulatory strategies for pharmaceutical and biologic products from different therapeutic areas, that allowed pharmaceutical and biologic companies to forecast with confidence their key milestones, develop and register their products successfully with FDA and meet their business goals.
Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in the US, European Union, Japan, China, LATAM, and ASEAN. GRPs dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.
Global Regulatory Partners Inc. (GRP) Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management. GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements. GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.
Medical Writing is an important function of regulatory affairs. It consists of writing scientific, technical documents and reports of different types which include regulatory and research-related information, disease or drug-related educational and promotional literature.
FDA expects to receive precise, clear and well-written technical and regulatory documents from pharmaceutical and biologic companies. Any bad writing can raise FDA queries and consequently can delay the FDA products’ review process and approval.
Products’ Registration
Overview:
The registration process of pharmaceutical and biologic products in US is a complex and very challenging process due to the amount of pre-clinical, pharmaceutical, CMC and clinical information that need to be included in the different modules of the registration dossier (Module 1, Module 2, Module 3, Module 4 and Module 5) to demonstrate the product‘s safety and efficacy , and also all the information must be presented and written in eCTD format.
Consultation meetings with FDA can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.
GRP regulatory affairs team supports includes: writing , preparation and submission of the meeting package to the FDA, prepare the questions to health authority based on the status of your product’s development and future plan, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting. GRP regulatory affairs team has organized and supported over 100 consultation meetings with FDA.
A DMF is required to supply bulk materials to the United States but the FDA does not require all manufacturers to submit a DMF. However, the information contained in a DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or related documents. DMFs are reviewed only when accompanied by an application.
| DMF Type | Information Content |
| Type I | Manufacturing Sites; Facilities; Operating Procedures |
| Type II | Drug Substance; Drug Products; Intermediates & Material used for preparation of DS and DP. |
| Type III | Packaging |
| Type IV | Excipient |
| Type V | Reference Information |
The term “Orphan drug” has two definitions. The first describes drugs or biologics that are used for the prevention, diagnosis, or treatment of diseases or conditions affecting fewer than 200,000 persons in the US. The second definition describes a drug or biologic that is intended for diseases or conditions affecting 200,000 or more people, or for a vaccine, diagnostic drug, or preventive drug to be administered to 200,000 or more persons per year, where the drug will not be profitable within 7 years following FDA approval.
Additionally, GRP Regulatory Affairs team provide support during the FDA review process of the NDA and ANDA he registration dossiers by answering FDA queries till receiving the NDA or ANDA approval. After approval, GRP Regulatory Affairs team will maintain the approved NDAs and ANDAs by preparing and submitting amendment as needed and the annual reports. Global Regulatory Partners, Inc., (GRP) regulatory affairs team has long-term experience in preparing, compiling and submitting to FDA Drug Master Files (DMFs) for active ingredients (APIs), Excipients and Packaging Materials for many API and packaging materials manufacturers. To learn more about our DMF services, check our presentations in the resource center pages.
GRP Whitepapers: Formal meeting with the FDA
FDA encourages sponsors to consult the agency during their products’ development program through one of its 3 types of formal meeting (Type A, Type-B and Type-C). Each meeting has its own purpose and process.
Orphan Drugs in the united States of America
In USA, the term “Orphan drug” has two definitions. The first describes drugs or biologics that are used for the prevention, diagnosis, or treatment of diseases or conditions affecting fewer than 200,000 persons in the US.
Clinical
Global Regulatory Partners, Inc (GRP) clinical team apply his therapeutic, regulatory, and operational expertise to consistently make sure that clinical studies are conducted in line with FDA GCP requirements and ICH guidelines. In an increasingly challenging environment, our clinical team has the experience and knowledge to find, recruit, and retain patients in clinical trials and successfully deliver access to appropriate sites and patients.
GRP’s national and international multi-site clinical services:
- Protocol Development
- Site and investigator identification and qualification
- Site initiation and training
- Clinical monitoring
- Medical Monitoring
- DSMB Coordination
- Statistical Analysis
- Electronic data capture
- Electronic Trial Master File
- Full- service data management
- ClinicalTrials.gov registration and management
- Central lab oversight and coordination
- Site quality assurance audits
- Integrated final Clinical Study Report
Quality Services
The US Food and Drug Administration requires manufacturers, specification developers, contract manufacturers, and relabels/preprocessor, and even some distributors must implement a quality system that meets the Quality System Regulation (QSR) for medical devices found in 21 CFR Part 820. The QSR is similar to ISO 13485 standard for quality management systems, but not the same.
As part of your full or partial QMS audit, monitoring your critical suppliers is both good business practice and a regulatory requirement. It is your responsibility to ensure proper manufacturing processes even if you rely on subcontractors for components of your manufacturing operation. We can conduct supplier audits on your behalf to assess whether your critical suppliers are adequately addressing your requirements in accordance with applicable standards and regulations.
FDA regulations require manufacturers to conduct regular internal audits of their quality management systems. GRP provides internal auditing services which allow for an independent review of your full quality system. We can also conduct specific QSR process audits in which we focus on specific areas of the quality system where you suspect non-compliance occurs or has occurred or focus on areas where conflicts of interest make an outside, independent GMP audit desirable.
Through this audit we will determine your current level of compliance with FDA regulation 21 CFR Part 820. The gap analysis can be conducted at any time on the quality system to identify deficient areas.
GRP can also perform a QSR audit that would mimic an FDA inspection to help the facility prepare for an actual FDA inspection. This type of audit can be done without the knowledge of the entire organization or provided as independent assessment of readiness without company personnel being aware. The FDA QSR mock audits are performed using the FDA’s Quality System Inspection Technique (QSIT) to prepare an organization for an actual FDA inspection.
GRP can conduct a gap or internal audit in anticipation of an FDA inspection or even assist during an actual FDA inspection. GRP can assist you in identifying any problem areas of your quality system prior to an FDA inspection. This type of FDA audit is similar to a gap audit, but we focus on any areas that may be reviewed more intently by an FDA Investigator, e.g. complaint handling, design control, corrective action, manufacturing processes, special processes, etc.
As an experienced consulting firm, GRP has helped many pharmaceutical companies comply with FDA 21 CFR Part 820 and ISO 13485 Quality Management Systems (QMS). Additionally, GRP can customize the FDA QSR quality management system to meet the client’s business needs. As its quality team doesn’t use “off the shelf” QMS solutions or QMS packaged software but create a tailored QMS for each customer that meets its business needs and complies with FDA QSR as well.
GRP Whitepapers: Formal meeting with the FDA
FDA encourages sponsors to consult the agency during their products’ development program through one of its 3 types of formal meeting (Type A, Type-B and Type-C). Each meeting has its own purpose and process.
GRP whitepaper: Remote Quality Audits
A remote quality audit, also known as a QA e-audit, is similar to an on site quality audit, the only difference is that it uses technology to communicate and evaluate documents and data remotely to determine the level of conformity of the auditee to the audit’s criteria and applicable quality standards.
GRP Whitepaper: US-FDA Pre-application Inspections
A pre-approval inspection (PAI) is performed to contribute to FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.
Cosmetics
USA Cosmetic Regulations:
In United States of America, Cosmetics are regulated by the Food and Drug Administration (FDA). Cosmetic are regulated by the Federal Food, Drug, and Cosmetic Act (FD &C Act) and the Fair Packaging and Labeling Act.
FDA Cosmetic Definition:
The FDA defines cosmetics as “articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any other part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance”(FD&C Act, sec 201(i)). This definition includes eye and facial makeup, perfumes, cleansing shampoo, hair colors, deodorants, permanent waves, lipsticks, and skin moisturizers.
GRP Cosmetic Services:
Global Regulatory Partners Inc., (GRP) can help your company find the right regulatory pathway for your cosmetics in US. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in the United States and find the appropriate local distributor for your product.
Authorized local agent
GRP Inc. has local offices in the United States and is licensed by the FDA. GRP Inc. can act as your local agent in the United States of America for your cosmetic and Personal Care Products.
GRP USA Cosmetic Services:
- Authorized local Agent
- Regulatory intelligence
- Regulatory Strategy
- Regulatory affairs
- Product Registration
- Cosmetic packaging and labeling review
- Product classification & Formulation Review
Product Registration:
The Law does not require that cosmetic products or ingredients (with the exception of color additives) to have FDA approval prior to entering the market. It is the firm’s responsibility to ensure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law. The FDA highly recommends voluntary registration of their cosmetics through the Voluntary Cosmetic Registration Program (VCRP). The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics.
VCRP COSMETIC REGISTRATION PROCESS
- The FDA highly recommends voluntary registration of their cosmetics through the Voluntary Cosmetic Registration Program (VCRP).
- The VCRP applies only to cosmetic products being sold to consumers in the United States.
- It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics.
GRP whitepaper: registration of cosmetics in usa
Cosmetics marketed in the United States, whether manufactured domestically or imported must comply with the following regulations: Federal Food, Drug, and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act External Link Disclaimer (FP&L Act).The Law does not require that cosmetic products or ingredients (with the exception of color additives) to have FDA approval prior to entering the market.
GRP usa cosmetic services:
- Regulatory intelligence,
- Regulatory strategy,
- Regulatory operations, and publishing; product registration,
- Product Classification
- VCPR Cosmetic Registration
- Regulatory Review of Packaging, labeling and formula of product.
Cosmetic packaging and labeling review
Labeling Requirements:
FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The FDA does not have the resources or authority under the law for pre-market approval of cosmetic product labeling. It is the manufacturer’s and/or distributor’s responsibility to ensure that products are labeled properly. Failure to comply with labeling requirements may result in a misbranded product. All labeling information must be in English. The only exception to this rule is for products distributed solely in a U.S. territory where a different language is predominant, such as Puerto Rico.
Packaging Requirements:
- The FDA requires all liquid oral hygiene products such as mouthwashes and all cosmetic vaginal products to be packaged in tamper-resistant packages when sold at retail.
- A package is considered tamper resistant if it has an indicator or barrier to entry (e.g., shrink or tape seal) which, if breached or missing, alerts a consumer that tampering has occurred.
GRP Labeling and Packaging Regulatory Review Services:
Global regulatory Partners, Inc., provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate region-specific regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with local and /or regional requirements and the products can be used safely by consumers.
GRP Inc. can review your products and make sure they comply with the FDA regulation for cosmetics, the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Fair Packaging and Labeling Act.
Product classification & Formulation Review
Global Regulatory Partners Inc. provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling. GRP Inc. can review your products and make sure they comply with the FDA regulation for cosmetics, the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Fair Packaging and Labeling Act.
Classification of cosmetic Products by the FDA
GRP whitepaper: How to Register a hand-sanitizer with the us-fda
The US FDA considers alcohol-based hand sanitizers as Over the Counter Products (OTC). The OTC are divided into two categories either health care antiseptics or consumer antiseptics. The registration pathway and indication depend heavily on the ingredients in the product.
Dietary Supplements
USA Dietary Supplement Regulations:
Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This regulation states that manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
Definition:
In the United States of America, FDA defines “a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.”
Pre-market approval:
Food Supplements do not have to be approved by the U.S FDA prior to commercialization except for New Dietary Ingredient (NDI). However they must register their establishment with the FDA and ensure their label follows the regulations.
GRP- USA Food Supplement Services:
Global Regulatory Partners, Inc. (GRP), has a team of experts in USA who can help Nutraceutical and food supplements companies in US during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.
forthcoming content
Understand the Process!
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