30 Day Trial

ORTHOKNOW content is posted to these pages in real time.

Monthly compilations are available in PDF form.


FDA Calls Out Common Mistakes in Orthopaedic 510(k) Submissions

Carolyn LaWell

Orthopaedic device companies will need to follow a new Refuse to Accept (RTA) policy for 510(k) applications submitted on or after October 1, 2015. Prior to the release of the new guidance, FDA spoke at OMTEC® 2015 on the sticking points of the policy and top reasons for deficiencies in orthopaedic device companies’ 510(k) submissions.

The updated guidance, “Refuse to Accept Policy for 510(k)s” issued August 4, is intended to offer applicants more clarity as to what must be included in the submission document.

While no major changes were made to the guidance, the revision modifies and streamlines the acceptance checklist submitted with and used during the application review process. The RTA checklist, which is recommended to be included with your submission, comprises 11 categories and 39 questions.

The processing timeline for a
traditional 510(k) is as follows:

   1. Refuse to accept decision: Day 15

   2. Substantive Interaction: Day 60

   3. Final Decision: Day 90

   4. Missed MDUFA Decision Process: Day 100

Constance Soves, Ph.D., a former premarket reviewer and current
regulatory advisor in the Office of Device Evaluation, Centers for Devices
and Radiological Health at FDA, said that manufacturers’ lack of attention
to basic details causes the greatest confusion for FDA reviewers and
slows the process.

“The most important thing is to make a good impression,” Soves said. “Please make effort to provide some organizational structure to the submission, mainly by including page numbers, headings and a table of contents. While the absence of these is not grounds for refusing a file,
these are certainly much appreciated.”

Other basic advice: Ensure consistency of device name and indication throughout the document and don’t dump data without providing a reason for the information.

Soves also offered perspective on the most common elements found missing by FDA during the RTA process.

  • Device Shelf Life: Your submission should include a summary of methods used to establish that the device performance is not adversely affected by aging, or include your rationale as to why the storage conditions are not expected to affect device safety or effectiveness.
  • Administrative: FDA’s question about prior device submissions is often misunderstood. FDA seeks to know whether the same device was previously submitted for FDA approval and the feedback that FDA provided about the device. FDA is not asking about predicate devices in this section.
  • Performance Data: A full test report, meaning an explanation of how the data generated from the test supports a finding of substantial equivalence, must be provided for each completed test on the device.

    Inadequate test reports are a top deficiency in orthopaedic 510(k) submissions, Soves said. Reports are deemed incomplete because they lack detailed methodology, e.g., sample size justification, test procedures and test conditions, and don’t offer discussion about the data results in comparison to the predicate device.
  • Labeling: Your indications for use must be stated in the labeling and match your indications for use in your 510(k) summary.
  • Sterilization: Companies often fail to state whether the device is sterile or not sterile, as well as submit completed test reports on the need for sterilization.

    A top deficiency in orthopaedic 510(k) submissions is inadequate cleaning instructions for reusable devices, Soves said.
  • Biocompatibility: Your submission must include a list of patient-contacting device components and associated materials of construction, as well as include identification of color additives, if present.

    In order to understand biocompatibility, the submission must include test protocol, methods, pass/fail criteria and results provided for each completed test or a statement and rationale for why biocompatibility testing is not needed.

    A top deficiency on the part of orthopaedic companies is not offering comprehensive data on color additives, Soves says. Your submission must include the commercial name of the colored materials, chemical name and the chemical abstract services number of each key colorant in the formulation, estimated absolute amount of colorant per device and evidence of biocompatibility of the base resin, as well as, if you know, identification of other U.S. marketed devices by device name and manufacturer where the colorants have been used.
  • Device Description: You must provide a list of compatible components and accessories (instruments) with their 510(k) numbers.

    “Remember, the reviewer needs to be able to understand everything about your device from what he sees in the submission,” Soves says. “Detailed description, schismatics, cross sectional images or any relevant means of conveying the features of your device are paramount. Sometimes a device sample can be helpful in the review of your device.”

FDA recently released data on how the agency is meeting its goals to speed up regulatory approval. Since the initiation of RTA on January 1, 2013, the  RTA rate has decreased from 58 percent during the 2Q13 to 37 percent in 2Q15. Clarity set forth by the latest document is expected to aid that number to drop lower.

The main structure of the RTA policy is unchanged, according to the new guidance. FDA will respond in the first 15 days after the submission on whether or not the information provided by the applicant is “administratively complete” or, in other words, missing necessary elements like those previously  mentioned.

If the submission is accepted, substantive review will begin. If it’s rejected, a list of the missing criteria is provided to the applicant. If day 16 comes and you haven’t received notification from FDA, check your junk mail before contacting FDA. Soves said not accounting for spam filters holds up a surprising amount of approvals.

Carolyn LaWell is ORTHOWORLD’s Content Manager. She can be reached by email.

   Ms. Soves' Recommended Reading for Companies Submitting a 510(k):

   “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”

   “Submission and Review of Sterility Information in Premarket Notification 510(k) Submission
    for Devices Labeled as Sterile”

   “Medical Device Accessories: Defining Accessories and Classification Pathway for New
    Accessory Types”

   “Reporting of Computational Modeling Studies in Medical Device Submissions” (Draft)