Elexes Team
Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.
As per the latest draft guidance issued by the US Food and Drug Administration (FDA), 4 “best practices” are mentioned for the process of selection of predicate device for a 510(k) program.
In accordance with the law, for all the eligible devices a manufacturer needs to submit a 510(k) notification at least 90 days before the device is introduced into interstate commerce for commercial distribution.
It is critical that the proposed device is substantially equivalent to the selected predicate device. Along with that, it is important that agency includes how the best practices were used to select the said predicate device in their 510(k) application.
You can also explore our article on 13 mistakes to avoid during 510(k) application.
List of best practices declared in the new draft guidance for selecting predicate device –
Included in the new draft guidance are the links to FDA and other databases to assist applicants in determining whether the proposed device meets all the best practices or not.
You will also find several examples that will reflect the best practices in play.
On top of all this, FDA also wants applicants to include 510(k) summaries in their application. These summaries must include the narrative explaining how they selected their predicate device & how best practices were used to support their submission.
In case, you need assistance with your 510(k) submission, you can contact our experts at Elexes Medical Consulting.
When it comes to selling cosmetics in the market, ensuring product safety and regulatory compliance is of utmost importance. One essential document for this purpose is the Cosmetic Product Information File (PIF).
The cosmetic PIF is a comprehensive document that contains all the necessary information about your cosmetic product and plays a vital role in ensuring product safety and compliance with regulations.
In this blog, we will discuss:
So, let’s begin our discussion…
The Cosmetic Product Information File (PIF) is a detailed & one of the key documents that should be created and maintained by the responsible person or company placing a cosmetic product on the market. The primary purpose of this file is to provide evidence of product safety and compliance with relevant regulations.
Below, we have the list of information that must be included in the Cosmetic PIF. Each of the following points demonstrate a specific necessity for regulatory compliance. Right from detailed product description, identification to regulatory documentation, you should include everything in this file.
We, at Elexes have professionals who can help you aggregate and prepare the file with all the key components mentioned below. All you have to do is contact us.
Start your PIF with a clear and precise product identification, including the product’s name, function, and intended use.
You can determine if your product falls under cosmetic, drug, or both by understanding the specification of each one of these categories. We have a complete guide that can help you with this – Whether your product is a cosmetic, drug or both?
Once you have determined that your product falls under cosmetics category, it is vital that you provide a detailed description of your product, including its physical characteristics, such as color, scent, texture, and form.
List all ingredients used in your cosmetic product, indicating their concentrations. Include International Nomenclature of Cosmetic Ingredients (INCI ) names and Chemical Abstracts Service (CAS) numbers must be included in the Cosmetic PIF.
Describe the manufacturing process, including quality control measures and any critical steps during production in the Cosmetic Product Information File (PIF).
Include a comprehensive safety assessment of the cosmetic product. This assessment should cover data on toxicological, chemical, and microbiological safety, as well as potential risks.
Provide information about the packaging and labeling of your product, ensuring it complies with relevant regulations regarding ingredient disclosure, batch coding, and warnings.
Include data on the stability of the product under different storage conditions, including shelf life studies and packaging integrity assessments in the Cosmetic PIF.
Clearly state any claims made about the product, ensuring they are substantiated and not misleading. This includes claims related to efficacy, benefits, and safety.
Include clear and concise instructions for consumers on how to use the product safely and effectively.
Mention any specific tests conducted, such as dermatological tests, ophthalmological tests, or clinical trials, and provide the results of these tests.
Ensure that the cosmetic PIF contains all the necessary regulatory documentation, including compliance with the EU Cosmetic Regulation (EC) No 1223/2009.
Clearly state the contact information of the responsible person or company, as well as the address where the PIF is located.
A well-prepared Cosmetic PIF not only ensures regulatory compliance, but also helps protect consumers and build trust in your brand. In the event of a product recall or safety issue, a comprehensive PIF can be invaluable in demonstrating due diligence and adherence to safety regulations.
In conclusion, creating a thorough and accurate Cosmetic Product Information File (PIF) is a fundamental step in the cosmetics industry.
By including all the essential elements mentioned above, you can demonstrate your commitment to product safety and compliance, ultimately benefiting both your business and the well-being of your customers.
Remember that regulatory requirements may vary by region, so it’s important to stay informed about the specific guidelines applicable in your target markets.
We are here to support your efforts in providing safe and high-quality cosmetic products to the market. All you have to do is contact us.
Click HereElexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.
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