510(k) Submission Services
Understanding Premarket Approval (PMA)
Premarket Approval (PMA) is a rigorous regulatory process managed by the FDA. It’s specifically designed for Class III medical devices, which are critical for supporting human life, preventing health impairments, or pose a significant risk of illness or injury if they malfunction. The PMA process is the most stringent type of device marketing application required by the FDA. It involves a thorough evaluation of scientific data and regulatory documentation submitted by the applicant to demonstrate the safety and effectiveness of the medical device for its intended use(s).
For a PMA application to be successful, the FDA requires substantial valid scientific evidence that supports the device’s safety and efficacy. This evidence typically includes clinical trial data, preclinical studies, manufacturing processes, and risk assessments. The FDA conducts a thorough review of this evidence to ensure that the device meets the necessary standards before granting marketing approval.
The regulatory framework for PMA is outlined in Title 21 Code of Federal Regulations (CFR) Part 814, which specifies the requirements, procedures, and standards for obtaining PMA approval. It’s crucial for applicants to adhere strictly to these regulations, as failure to meet PMA requirements can result in the device being deemed adulterated under section 501(f) of the FD&C Act, prohibiting its marketing until compliance is achieved.
The standard fee for PMA submission is $483,560 and $120,890 for small businesses.
Different Methods of PMA Submission
There are four different PMA submission methods that medical device manufacturers can apply: Traditional PMA, Modular PMA, Product Development Protocol, and Humanitarian Device Exemption.
When is a PMA Required?
Premarket Approval (PMA) is required for medical devices falling under Class III, which is the most stringent regulatory category designated by the FDA. Class III devices encompass those that are essential for supporting or sustaining human life, have significant importance in preventing health impairment, or present a potential and unreasonable risk of illness or injury if they malfunction or are used incorrectly. These devices undergo thorough scrutiny and evaluation by the FDA to ensure their safety and effectiveness before they can be marketed and used by healthcare professionals and patients.
Required Elements for PMA Submission
The items that need to be included in a PMA (Premarket Approval) submission are as follows:
- Applicant Information
- Table of Contents
- Summary Section
- Complete Description of the Device
- Reference to Performance Standards
- Technical Sections
- Bibliography
- Samples of the Device (if requested by the FDA)
- Proposed Labeling
- Environmental Assessment (if applicable)
- Financial Certification or Disclosure Statement
- Other Information
PMA Review Process and Timeline
The review process for a PMA submission involves several steps:
Day 1 | Day 15 |
Company submits PMA application to the FDA | FDA conducts Acceptance Review and informs companies if their applications have been accepted for Substantive Review or placed on RTA hold. |
Day 45 | Day 70 |
FDA notifies the company if its application has been filed, and, if so, Substantive Review begins. | Deadline for requesting a Day-100 Meeting. |
Day 90 | Day 100 |
FDA completes Substantive Review and Interactive Review begins. | Meeting with FDA review team if requested. Companies may request a Day 100 Meeting (a type of Q-Submission) to review the status of PMA applications (either for original PMAs or amended applications). |
Day 180 | Day 320 |
FDA completes Interactive Review and issues a decision letter to the company. | FDA issues a decision letter for PMAs requiring a Panel Meeting. |
Who Needs to Submit a PMA?
The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a PMA. Instead, they specify which actions, such as introducing a device to the U.S. market, require a PMA submission.
When is a PMA Required?
Unless exempt, if you are introducing a device into commercial distribution for the first time, you must make a PMA submission at least 90 days before offering the device for sale. This requirement applies to devices marketed after May 28, 1976, regardless of whether they were in development or undergoing clinical investigation before that date. If your firm did not market the device before May 28, 1976, a PMA submission is necessary.
Why Choose us?
Navigating the PMA regulatory pathway can be a complex and daunting task. That’s where our team comes in. We bring to the table a wealth of experience and a track record of success in securing FDA clearance for Class III medical devices. Our unique approach combines technical know-how, clinical expertise, and regulatory understanding, enabling us to tackle challenges head-on and fast-track your product’s journey to the market. We’re well-versed in the intricacies of the PMA process and can guide you every step of the way, from preparing your submission to responding to FDA inquiries. Additionally, we offer translation services for key documents, ensuring you’re never lost in translation. Opt for our PMA services and discover the difference our expertise, dedication, and customer-centric approach can make in your regulatory journey.
About Accel
Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.
