FDA PMA Medical Devices

Medical DevicesFDA Medical Devices Application

U.S. FDA Medical Device PMA

Pre-market Approval (PMA) is the FDA's scientific and regulatory review process for assessing the safety and effectiveness of Class III medical devices. Class III devices are those intended to support or sustain human life, which are of significant importance in preventing, or potentially preventing, health problems and treating diseases.

Due to the risk level of Class III PMA medical devices, the FDA considers that general and special controls are insufficient to ensure the safety and effectiveness of these devices. Therefore, these devices require a Pre-market Approval (PMA) application in accordance with Section 515 of the FD&C Act to obtain marketing authorization.

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Medical DevicesObtain U.S. Marketing Authorization

Any medical device intended for sale in the United States must obtain marketing authorization

Pre-market Approval (PMA) applications require the submission of scientifically regulated documents to the U.S. FDA to demonstrate the safety and effectiveness of Class III devices. While PMA applications include certain administrative elements, the presentation of robust scientific data and professional writing within the scientific community are critical for the approval of PMA applications.

If a PMA application lacks elements listed in the management checklist, the FDA will reject the PMA application and will not conduct an in-depth review of the scientific and clinical data. If the PMA application lacks valid clinical information and academic analysis based on reasonable scientific reasoning, it may affect the FDA's review and approval. Incomplete, inaccurate, inconsistent, or disorganized PMA applications that omit key information can lead to delays in the approval or rejection of these applications. Manufacturers should perform a quality control review of the PMA application before submitting it to the FDA to ensure it is scientifically sound and presented in an organized format.

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Data Organization and AnalysisTesting Data Required for Medical Device Applications

Collaborate with global partners to provide technical documentation compliant with ISO, GLP, and FDA regulations, including the testing data required for medical device submissions. Utilize known data to establish a complete data chain for regulatory authorities, ensuring that medical device data is clear and controllable for submission to regulatory agencies.

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Medical DevicesNon-Clinical and Clinical Laboratory Studies

Arrangements for Non-Clinical and Clinical Laboratory Studies of Medical Devices

The non-clinical laboratory studies section includes information related to microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal testing. Non-clinical studies for safety assessment must be conducted in accordance with 21 CFR Part 58 (Good Laboratory Practice for Non-Clinical Laboratory Studies). We assist you in determining the appropriate non-clinical study research while referring to the applicable guidance documents and standards identified for your device type in the product classification database.

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