FDA 510k 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.

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

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.

Step 1

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
Link:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
2. Identifying another (predicate) device with the same intended use and technology.

Step 2
Identify the device variants and models

Step 3
start Developing 510k technical file

Step 4
start Developing 510k technical file

Step 5
Identify Test requirements ( Biocompatablity / Performance / Safety)

Step 6
Complete Validation and update latest reports to 510k File (Software / Sterilizations / Cleaning / Shelf Life)

Step 7
Complete transport Validation and update latest reports to 510k File.

Step 8
Risk Analysis

Step 9
Draft Primary packing information and secondary packing information (Labels / Cartons)

Step 10
Develop and update 510k file with latest revisions of IFU / User manual/ Operating Manual

Step 11
Review the 510k file and convert it into electronic form

Step 12
Appoint US Agent ( Foreign Manufactures only)

Step 13
Pay FDA Review Fees

Step 14
Pay FDA Review Fees

Step 15
Submit 510k files to FDA.

Step 16
Wait for initial response and submit an updated file to FD again (if required)

Step 17
Wait for clearance latter / K number

Step 18
Proceed with Establishment Registration and Listing

Step 19
Start selling the device in the USA.

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.

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