What are the major types of PMA submissions?

There are four types of PMA application methods, including a traditional PMA, modular PMA, product development protocol (PDP), and humanitarian device exemption (HDE). During the approval process, you demonstrate a commitment to product quality.

What is a PMA letter?

Parts Manufacturer Approval (PMA) is an approval granted by the United States Federal Aviation Administration (FAA) to a manufacturer of aircraft parts.

How do I submit a PMA?

A PMA must be submitted in an electronic format (eCopy), with a signed, printed cover letter. A PMA must be signed by the applicant or an authorized U.S. representative. If the applicant does not reside or have a place of business within the U.S., the PMA must be countersigned by an authorized representative who does.

How long does PMA approval take?

According to a report from the agency, the average PMA application is approved 243 days post-submission. That’s just over eight months, or 66 days longer than the average time to approval for a 510(k) application.

Why would the FDA refuse to file a PMA?

FDA may refuse to file a PMA if FDA determines that any of the following applies: The applicant has a pending Premarket Notification 510(k) with respect to the same device, and FDA has not determined whether the device falls within the scope of Sec. 814.1(c). The PMA contains a false statement of material fact.

What is the difference between a 510k and PMA?

A PMA is more in-depth than a 510k – it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing.

What is PMA material?

Poly(methyl acrylate) (PMA) is a hydrophobic synthetic acrylate polymer. PMA, though softer than polymethyl methacrylate (PMMA), is tough, leathery, and flexible.

What is a Denovo submission?

The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

Are PMA supplements free?

Human Melanocyte Growth Supplement-2 (HMGS-2), PMA-free, is a sterile, concentrated (100X) solution intended for use with Medium 254 or Medium 254CF to culture human epidermal melanocytes.

How much does PMA cost?

Rare and Costly Process Part of the cost is in the form of a user fee from the FDA, with the standard fee for PMA set at nearly $235,000, compared to $4,690 for 510(k). PMA requires extensive data from laboratory and clinical studies, which are not required under the more lenient 510(k) process.

Do all Class III devices require a PMA?

Although most Class III devices are subject to FDA’s Premarket Approval (PMA), there is an exception: Class III devices that were already on the market in 1976 or before the FDA was given authority in this area. These devices are not subject to PMA.