Learning Premarket Approval (PMA) through questions and answers. (Part 1)

Q.1) What is PMA?

A.1) Any premarket approval application for a medical device.

Q.2) What is the PMA Amendment?

A.2) To modify a pending PMA or Pending PMA supplement.

Q.3) What is a PMA Supplement?

A.3) It is an application to effect modification in already approved PMA for class III medical devices.

Q.4) Who is a “Person” wrt PMA?

A.4) A Person can be individual, partnership, corporation, association, scientific or academic establishment, governmental agency or its department.

Q.5)What is material fact?

A.5) Important information that may affect a decision in the court of law.

Q.6) What is a “statement of material fact”?

A.6) A representation that shows the safety and effectiveness of a device more likely than in its absence of representation.

Q.7) What is considered a false statement of material fact?

A.7) False affirmation, silence or omission wrt safety and effectiveness.

Q.8) What is 30-day PMA?

A.8) A supporting or supplemental application to an approved PMA within 30 days by FDA.

Q.9) What is a reasonable probability?

A.9) An event more likely that it will occur than it's not.

Q.10) What is serious and adverse health consequences represent?

A.10) It represents Life-threatening, permanent injury, and long term injury.

Q.11) What is a human device exemption(HDE)?

A.11) Exemption of HDE from effectiveness requirement.

Q.12) What is a humanitarian use device(HUD)?

A.12) A device intended to benefit the patient the disease of which occurs in less than 4000 individuals in the USA.

Q.13) What is the Unique Device Identifier (UDI)?

A.13) Identifier that identifies the medical devices. It includes lot and batch number, serial number and expiration date.

Q.14) What is UPC?

A.14) Universal Product Code — to identify sales at retail level.

Q.15) What does the PMA file include?

A.15) All data and information, any IDE incorporated into PMA, any PMA supplement, any report wrt post-approval requirement, master file and related submissions.

Q.16) Can FDA disclose the existence of the PMA file before approval?

A.16) NO

Q.17) When can FDA disclose the PMA file?

A.17) When the information has been in public or acknowledged before approval. Then the FDA can disclose information. Also, summaries related to safety and effectiveness can be disclosed.

Q.18) When and what does FDA disclose information?

A.18) FDA can disclose PMA information after the order of approval or denial. Any protocol for a test or study, list of components, consumer complaint, adverse reaction reports, all correspondence and written summary of the oral discussion and All safety and effectiveness data is disclosed by the FDA.

Q.19) When will FDA consider that the PMA has been abandoned?

A.19) When an applicant fails to respond within 180 days for additional information, If work is not being undertaken, If FDA notifies to sponsor that PMA appears to be abandoned and sponsor fails to respond within 7 days of such notice.

Q.20) What data and information are not available for public disclosure?

A.20) Manufacturing methods, manufacturing processes, quality control procedure, production, sale, distribution, and similar data and information. quantitative and semi-quantitative formulas are not available for public disclosure.