FDA 510k - A Complete Overview
An FDA 510k is the technical dossier that must be submitted to the US Food and Drug Administration (FDA) for devices meant to be used on humans. The application is made to the FDA by a medical device manufacturer or a specification developer to demonstrate that the device to be marketed is as safe and effective, substantially equivalent, to a legally marketed device in the USA.
The 510(k) documentation must include a description of the medical device, models, and accessories or components that come in direct contact with patients, as well as device performance specifications. Once FDA determines the submitted device is substantially equivalent, a 510(k) number is granted, or in other words, 510k approval is granted. It is not to be called an FDA 510k Certification or 510k registration
The 510k submission is also known as a Pre-market Notification. This includes technical, performance, and safety information about the medical device. A submission must be made for devices, which do not need a Premarket Approval (PMA) and are not exempt from the 510k requirements by manufacturers who wish to market their medium-risk medical device or IVD in the U.S. The 510k submission is also known as a Pre-market Notification.
The regulatory documentation submitted as part of 510(k) should be able to demonstrate the proposed device is at least as safe and effective as a legally marketed device in the U.S.A Legally marketed device is a medical device that has already been received 510k clearance for sale in the U.S.
To prove substantial equivalence, the similarities and differences between the proposed device and predicate device will have to be compared, and suitable laboratory testing must be performed. Human testing is not generally needed as part of FDA 510k submissions. Submissions are generally required for most Class II medical devices, Class I and Class III devices, and IVDs.
Generally, there is three types of 510k’s: (1) Abbreviated 510(k) (2) Traditional 510(k) (3) Special 510(k). More details can be found in the article section below.
FDA Medical Device Classification
- Class I: Simple risk-free devices. The majority of the class 1 devices are subjected to general regulatory controls and do not require any 510(k) clearance.
- Class II: Devices pose a moderate level of risk to the user. The majority of the class II devices require a 510(k) submission and clearance before being legally marketed.
- Class III: Devices pose a high risk to the user and could lead to significant adverse outcomes for the patients. Most class III devices require a 510k submission, and a few require PMA submission before being marketed in the USA.
510k Submission Process
- 510(k) technical documentation
- Device Testing
- Demonstration of Substantial equivalence
- FDA Review Fees payment and 510(k) submission
Some of the applicants will do pre-submission to FDA to avoid any undue surprise rejection in the last stage. Careful planning, strategic decisions, and expertise of our consultants will ensure the early acceptance of the 510(k) file without RTA or AI and the successful clearance of the 510k submission.
510(k) Certification or 510k Approval
Premarket Notification or PMN or 510(k) is not a Certification issued by FDA to your devices, unlike CE Mark Certificate issued by Notified Bodies in Europe. Once you demonstrate the substantial equivalence with already 510k cleared device, FDA gives 510(k) approval or clearance.
General Timeline for 510k Clearance
Manufacturers and applicants must understand the timeline under a practical approach.
- FDA 510k Preparation, including external testing, can go from 3 months to 6 months depending on device nature and variants.
- US Congress has given a timeline of 90 calendar days to review a 510k file; however, our experience and practical calculation of most of the 510k file reviews and the final decision can happen anywhere between 140 to 200 days.
Role of FDA 510k Consultant
To ensure a successful 510(k) submission and clearance, the role of the consultant is very much vital. The following are the service we provide customers to reduce the cost, duration, and failures in 510k submission.
- Pre 510(k) submission GAP analysis
- Document compilation and FDA 510K (Pre & Original) submission
- US Agent Service and Submission Service Only
- Abbreviated 510(k) preparation, submission, and FDA coordination till clearance: $ 20000
- Traditional 510(k) preparation, submission, and FDA coordination till clearance: $ 24000
- We normally take around 60-90 days for the 510(k) preparation.
Quality of the FDA 510(k) matters!!! In terms of fewer review comments and fast clearance. FDA 510(k) technical file preparation can be challenging with the stricter requirements in terms of file structure covering 17 individual modules to address each 510(k) requirement. All relevant protocols, test reports, and other supporting evidence are provided in specified annexures with appropriate file numbering and appropriate titles. Most of the 510(k)s are well over 250 pages. The FDA 510(k) must be suitable for FDA’s eCopy submission requirements.
What is Pre-Submission
Pre-submissions are made to the FDA for taking feedback about the quality of the file and its content. They are used for various intensions including meeting requests, to study risk determination, for submission issues, and for FDA feedback to specific questions related to a pending submission or protocol.
Explain Pre- Market Approval
Premarket approval (PMA) is the FDA process of scientific and regulatory analysis to assess the safety and efficacy of Class III medical devices. PMA is the strictest type of medical device marketing application required by the FDA. The medical device manufacturer or the seeker must receive FDA approval of its PMA application prior to marketing the device. The PMA approval is based on a decision by FDA that the PMA contains sufficient authentic scientific evidence to assure that the medical device is safe and effective for its intended use(s).er 2
When should I submit a 510(k)?
510(k) is needed when:
Anyone who is intending to sell their medical device(s) in the USA must make an FDA 510k submission at least 90 days prior to contributing the medical device for sale, even though it may have been under development or on a clinical investigation before that date.
Difference or change in the intended use for a medical device that you already have in commercial distribution.
If there is a difference or modification of a legally marketed medical device and that change could significantly affect its safety or efficacy.
A new submission is required for changes or alterations to an existing medical device, where the alterations could significantly affect the safety or efficacy of the medical device or the medical device is to be marketed for a new or changed indication for use.
Explain 510k submission and 510k approval process
Find out the classification of your medical device or in vitro diagnostic (IVD) device in two ways.
1. Use FDA classification database using relevant search terms
2. Identifying another (predicate) device with the same intended use and technology.
Identify the device variants and models
start Developing 510k technical file
start Developing 510k technical file
Identify Test requirements ( Biocompatablity / Performance / Safety)
Complete Validation and update latest reports to 510k File (Software / Sterilizations / Cleaning / Shelf Life)
Complete transport Validation and update latest reports to 510k File.
Draft Primary packing information and secondary packing information (Labels / Cartons)
Develop and update 510k file with latest revisions of IFU / User manual/ Operating Manual
Review the 510k file and convert it into electronic form
Appoint US Agent ( Foreign Manufactures only)
Pay FDA Review Fees
Pay FDA Review Fees
Submit 510k files to FDA.
Wait for initial response and submit an updated file to FD again (if required)
Wait for clearance latter / K number
Proceed with Establishment Registration and Listing
Start selling the device in the USA.
Electronic Copy (e-copy) Submission
An electronic copy or e-copy is an electronic version of the medical device submission prepared and submitted on CD, flash drive, or in a DVD. E Submission contains documents intended for computer processing as well as human-readable documents. An electronic copy is required for most of the FDA medical device submissions including the following.
• 510(k) submission, including the 3rd party submission.
• De Novo
• PMA. Modular PMAs
• IDE Submissions
• HDE submissions
• INDs (investigational new drug applications)
• Q submissions
The response to deficiency or the additional information are required to be submitted to the DCC as an amendment or a supplement, and thus subjected to e copy. Usually, one e copy and a single paper copy of signed cover letter are required while submission. It is recommended to not exceed 1 GB for a submission file size for ease of processing or delay. Pdf files with bookmarks and hyperlinks are recommended but not mandatory. Preferably the pdf files created from the source file, or it may be recognized with OCR character recognition.
The Applicants can verify the e copy using the free eCopy Validation Module to determine whether it meets the technical standard of electronic copy.
Summons of Premarket Approval (PMA)
The FDA's PMA procedure is one of the scientific and regulatory reviews used to assess the efficacy and safety of Class III medical devices. Before beginning any marketing initiatives, the applicant must get approval for their PMA application. The scientific evidence demonstrating that the device is safe and effective for the planned purpose described in the application is what determines whether the PMA will be approved. The PMA application should be approved or rejected within 180 days, but in practice, it frequently takes longer. The FDA will forward the application to the relevant advisory group for assessment at a public meeting after the applicant submits the PMA. In order to decide whether to approve or deny the application, the committee will present its recommendation and supporting evidence.
Once the submission is determined by FDA, the applicant will be notified about approval or rejection of their application and FDA publishes a notice on their website with the aims of
1. Stating the data on which the decision is based, and
2. Rendering interested people an opportunity to petition FDA within 30 days for reconsideration of their decision.
On successful completion of a PMA process, an approval in the form of a private license acknowledging the applicant a permission to market the device is released