Premarket Approval (PMA)

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance. Please note that some Class III preamendment devices may require a Class III 510(k).

PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device.

The technical sections containing data and information should allow FDA to determine whether to approve or disapprove the application. These sections are usually divided into non-clinical laboratory studies and clinical investigations.

Non-clinical Laboratory Studies' Section:

Non-clinical laboratory studies' section includes information on microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests. Non-clinical studies for safety evaluation must be conducted in compliance with 21CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies).

Clinical Investigations' Section:

Clinical investigations' section includes study protocols, safety and effectiveness data, adverse reactions and complications, device failures and replacements, patient information, patient complaints, tabulations of data from all individual subjects, results of statistical analyses, and any other information from the clinical investigations. Any investigation conducted under an Investigational Device Exemption (IDE) must be identified as such.

FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer.

LMG will assist you throughout the PMA process, our services include

  1. Assist you in developing study protocols
  2. Prepare your manufacturing facility for FDA plant inspection
  3. Assist you in preparing the submission
  4. Prepare you for participate in FDA review meetings
  5. Participate in FDA review meeting ,if needed

FDA review Fees for PMA� FY 2007 to 2012

Fiscal Year







PMA Standard Fee

$ 281,600

$ 185,000

$ 200,725

$ 217,787

$ 236,298

$ 220,050

PMA Fee for Small Businesses

$ 107,008

$ 46,250

$ 50,181

$ 54,447

$ 59,075

$ 55,013

FDA review fee is waived for First premarket approval submission (PMA) from firms with gross receipts or sales less than $30 million.



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