MedTech Product Timeline: FDA
Medtech products typically take between one week and eight months from the point of FDA submission to FDA approval depending on the required approval pathway, which is a factor of the risked-based classification of products into Classes 1 – 3.
- There are regulatory pathways for each device class, including:
- Premarket approval (PMA), which is the strictest and meant to evaluate the safety and effectiveness of the device, and is required for products such as digital mammography and implanted defibrillators; and
- 510(k), which is meant to prove that “the device is substantially equivalent to a legally marketed device that is not subject to PMA.” It is required for devices such as x-ray machines, fetal monitors, and muscle stimulators.
Submission to Approval Timeline and Key Milestones Along the Way
- The FDA completes an administrative acceptance review and responds within 15 days of receiving a submission along with an eCopy and a user fee.
- Any issues at this stage may cause the review to be put on hold. The sponsor will be notified and have 180 days to resolve the issues.
- In the absence of issues, the FDA “will assign a lead reviewer and notify the applicant of acceptance for a complete review.”
- While under review, the FDA will have communications with the applicant to help make the process more efficient. For 510(k) submissions and PMA submissions, these communications happen within 45 days and 75 days, respectively, of their acceptance for a complete review.
Typical Timelines Per Device Class
- The FDA is not clear as to the average timeline from submission to acceptance for Class 1 devices, but these devices take the shortest pathway to market of about one week as the majority of them can go through the self-registration process.
- However, a small percentage of Class 1 devices require a 510(k) submission, as do the majority of Class 2 medical devices.
- It typically takes an average of 177 days (close to six months) to be approved, with only 19% of devices on the 510(k) pathway getting approval within three months.
- Yet, depending on the device category, the average timeline for approval can vary from 163 days, for toxicology devices, to 245 days, for anesthesiology devices. Note, however, that there is an impending overhaul of the 510(k) pathway, which might alter the approval timeline.
- The majority of Class 3 devices take the premarket approval (PMA) pathway, which currently takes an average of 243 days post-submission (just over eight months).
MedTech Product Timeline: NTAP
A typical medtech product goes through a series of steps before it is approved. The initial step entails assessing whether the medical technology meets NTAP criteria of newness, cost, and clinical improvement. A detailed outline and description of the timeline and steps involved with a focus on the 2022 application for the traditional pathway is presented below.
Assessment of the Technology’s Ability to meet NTAP Criteria
- The first step in the NTAP approval process is assessment to establish whether a medtech product meets the criteria provided. According to Centers for Medicare & Medicaid Services (CMS), to qualify, a technology must attain three criteria namely newness, cost, and clinical improvement.
- The newness criterion aims to ensure that the technology is not substantially similar to any of the existing technologies. The cost criterion establishes whether the technology is inadequately compensated under the prevailing MS-DRG system. Lastly, the clinical improvement criterion assesses the technology’s ability to improve clinical outcomes for the targeted patient population relative to the existing available treatments.
- For the 2022 application, the assessment was done in August 2020 for an application going through the traditional pathway.
Submission of NTAP Application
- After assembling all the necessary information including contact information, name of the technology, and its description, the application is submitted within the deadline indicated. For the 2022 applications, the deadline for application is October 2020.
Preparation of ICD-10-PCS Request
- This step entails preparation of International Classification of diseases, 10th Revision, Procedure Coding System request as required by CMS. For 2022 applications, the preparation will be done in November 2020.
Development and Presentation of Town Hall Presentation
- The medtech approval applicant must prepare a presentation to present at the Town Hall on a scheduled date. The presentation gives the public an opportunity to provide their input on whether a technology or service is an advancement in medical technology that substantially improves care delivery prior to the publication of a proposed rule.
- The applicant also receives recommendations and comments from the public and other interested parties such as manufacturers, physicians, and hospitals, among others. Such opinions and presentations help in evaluating the medical technology.
- For the 2022 applications, the Town Hall preparation and presentation will be done between November and December 2020.
Submission of ICD-10-PCS Code Request
- The next step is the submission of ICD-10-PCS Code Request. For the 2022 application, submission will be done in December 2022.
Development of ICD-10-PCS Presentation and Presenting ICD-10 C&M Committee Meeting
- After preparing the ICD-10-PCS presentation, the applicant makes a presentation at a meeting with ICD-10 Coordination and maintenance Committee. The committee is charged with the responsibility of approving coding changes, developing errata, addenda, and other changes.
- The committee offers a public forum to debate about proposed changes to ICS-10. Participants are encouraged to ask questions and offer recommendations concerning the coding and clinical issues. However, the meeting does not make any final decisions.
- For the 2022 application, the meetings will occur between January and March 2021.
Drafting and Submitting IPPS Comment Letter
- After the IPPS proposed rule is released, the applicant prepares and submits a comment letter with their view concerning the rule. The rule may focus on aspects such as payment and quality provisions. For considerations, the applicant must submit the comments within the stipulated time frame.
- For 2022 application, the submission will be made in June 2021.
Release Inpatient Prospective Payment System (IPPS) Final Rule
- After all the comments and recommendations have been reviewed, a final rule is published by CMS. The rule makes various changes annually and takes effect every October 1 each year.
- For 2022 application, the final rule will be released in August 2021.
If Awarded, NTAP Effective
- If a 2022 NTAP application is awarded, its approval will take effect from October 1, 2021.