FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!

As per the latest draft guidance issued by the US Food and Drug Administration (FDA), 4 “best practices” are mentioned for the process of selection of predicate device for a 510(k) program.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List of best practices declared in the new draft guidance for selecting predicate device –

  • A predicate device must be cleared as per the well-established methods like FDA recognized voluntary consensus standards, an FDA guidance document, widely available and accepted method published in the public domain or scientific literature, or qualified medical device development tool.
  • Only a predicate device that meets or exceeds expected safety and performance standard must be selected. FDA recommends that while selecting a predicate device, the applicant must consider any reported medical device-related adverse event, malfunctions, or deaths that may have played a role in the safety and effectiveness of the predicate device.
  • FDA needs to be sure that there are no safety concerns with the selected device. Appropriate documentation must be added in the application if the selected predicate device comes with unmitigated use-related or design related safety issues.
  • Predicate devices without an associated design-related recall.

Included in the new draft guidance are the links to FDA and other databases to assist applicants in determining whether the proposed device meets all the best practices or not.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:

  • What is cosmetic PIF?
  • The important elements you should include in your Cosmetic PIF to meet regulatory requirements and safeguard your consumers.

So, let’s begin our discussion…

What is a Cosmetic PIF?

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.

Key Components of a Cosmetic PIF

Key Components of a Cosmetic PIF

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.

  • Product Identification

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?

  • Product Description (A Key Component of Cosmetic PIF)

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.

  • Composition and Formulation

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.

  • Manufacturing Method

Describe the manufacturing process, including quality control measures and any critical steps during production in the Cosmetic Product Information File (PIF).

  • Safety Assessment

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.

  • Product Packaging

Provide information about the packaging and labeling of your product, ensuring it complies with relevant regulations regarding ingredient disclosure, batch coding, and warnings.

  • Stability Data

Include data on the stability of the product under different storage conditions, including shelf life studies and packaging integrity assessments in the Cosmetic PIF.

  • Product Claims

Clearly state any claims made about the product, ensuring they are substantiated and not misleading. This includes claims related to efficacy, benefits, and safety.

  • Consumer Usage Instructions (Must include in Cosmetic PIF)

Include clear and concise instructions for consumers on how to use the product safely and effectively.

  • Product Testing

Mention any specific tests conducted, such as dermatological tests, ophthalmological tests, or clinical trials, and provide the results of these tests.

  • Regulatory Documentation

Ensure that the cosmetic PIF contains all the necessary regulatory documentation, including compliance with the EU Cosmetic Regulation (EC) No 1223/2009.

  • Responsible Person Information

Clearly state the contact information of the responsible person or company, as well as the address where the PIF is located.

The Significance of a Well-Prepared PIF

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.

If you need assistance with preparing your cosmetc PIF or ensuring compliance with cosmetic regulations, don't hesitate to reach out to our team of experts.

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.

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Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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