For those readers wishing to learn just a tad-bit more about the FDA’s PMA process; please continue with the reading of this week’s guidance. Dr. D will attempt to teach, enlighten, and hopefully entertain you in the process. If your chief Jailable officer (CJO) believes that short-cuts are always available when pursuing a PMA, the doctor just purchased the new eastern span of the Bay Bridge and would like to sell it. The doctor will be the first one to tell colleges that FDA’s approval process for Class III device can be perceived as a “sinuous” (look-it-up) path. This is especially true if FDA has concerns over the pallet full of data an organization has submitted as their PMA.
“Class III devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. They have the toughest regulatory controls. Most of these devices require Premarket Approval because general and special controls alone cannot reasonably assure their safety and effectiveness.”
As for the PMA application process, it is strongly recommend that you confer with the agency in advance. Number one, FDA will be better prepared to commence with the PMA review process associated with your organization’s submission; and number two, it will set the initial expectations in regards to the review process. Section 814.20 delineates the PMA application process. As a minimum, the application will need to contain (as applicable):
- Applicant name and address;
- Table of contents;
- Product summary containing: (a) indications for use; (b) device description; (c) alternative practices and procedures; (d) marketing history; (e) summary of clinical and non-clinical studies; and (f) conclusions drawn from the studies.
- A detailed description of: (a) device; (b) functional components/ingredients; (c) device properties; (d) theory of operation; and (e) manufacturing methods;
- References to claimed standards;
- Technical sections including: (a) results of nonclinical laboratory testing; (b) biological compatibility testing; (c) aging studies; (d) package testing, etc.
- Compliance statement for studies stating that the studies were performed in accordance with Part 812 or Part 813 (for example);
- Rationale for when clinical data comes from just one investigation site;
- Bibliography of published reports;
- Samples of the device, if requested by FDA;
- Copies of proposed device labeling;
- Environmental assessment;
- Financial certification and disclosure statement;
- Other information requested by FDA; and finally,
- Do not forget to sign the application!
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2013, April) Title 21 Part 807: Establishment registration and device listing for manufacturers and initial importers of devices. Washington,
- D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (2013, April). Title 21 Part 814: Premarket approval of medical devices. Washington, D.C.: U. S. Government Printing Office
- Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.