ALDA & Associates International, Inc. Newsletter
July/August 2010
Understanding the Food and Drug Administration (FDA) Requirements for Medical Devices
(Part 2)
by David H. Fater
There has been a lot of publicity recently about medical device regulation and several major companies have encountered legal and financial problems as a result of not fully complying with the FDA requirements governing the process by which medical devices are cleared to be marketed. It can differ dramatically from the manner in which drugs are approved for use and it is useful to review the FDA requirements for our readers. Hopefully, this may prove benficial to both readers who are contemplating the approval process for a device as well as those who turn out to be patients and have devices used on them. Part 1 reviewed the 510(k) process which is the faster and easier process by which devices can be cleared for marketing. Part 2 will cover the process when a device does not have a substantially equivalent device already on the market.
The FDA regulatory framework regulating most types of medical devices is the Federal Food, Drug and Cosmetic Act. (FDC Act). In order to enter the United States Device Market, the FDA has provided two primary routes for obtaining authorization to market medical devices. Those are: (i) 510(k) premarket clearance which was reviewed lst month and (ii) Premarket approval (PMA). In this month's edition, we will review the PMA requirements which are more onerous than the 510(k).
The key point here is that before a device company can market a new device, they must first obtain from the FDA either a 510(k) premarket clearance or a pre market approval (PMA) unless the device is exempt. The 510(k) process is a relatively faster route through the FDA because you merely have to substantiate that the device is "substantially equivalent" to a device that is already on the market (the predicate device). This is a much lower hurdle to cross than a PMA which is much more extensive and expensive.
The PMA requirements include:
- Complete description of the device
- Complete description of the components
- Photographs
- Engineering drawings of the device
- Detailed description of the methods, facilities and controls used to manufacture
- Prepared labeling, advertising literature, any training material
- Software documentation
- Sterility information
- Biocompatibility information
- Extensive clinical trials
- Animal studies
- Bench tests
- Published and unpublished literature
- Bibliography of all published reports known concerning the device’s safety or effectiveness.
In order to obtain the necessary clinical trial data with which to receive PMA clerance, the device obviously has to be used on human subjects to generate the clinical trial data. How does one utilize the device when it is not approved for marketing?? Well, the FDA has provided for this through the Investigational Device Exemption provisions. Basically, devices that are not approved or cleared and are used in clinical trials must be labeled as Investigational Devices “IDE”. In order to obtain an Investigational Device Exemption, the FDA may request and have submitted to them the following materials:
- Animal or human clinical data to demonstrate safety and effectiveness of a device
- Statement concerning whether the device carries with it significant risk
- Prior approval by for the trial by an Institutional Review Board (IRB). (This can sometimes be a Catch-22 as the IRB may require an IDE for the device to be used in the clinical trial).
- Example of the Informed consent to be obtained from patients
The submission of these materials could result in the issuance of FDA approval of an IDE application.
Under Code 21 CFR Part 812, the IDE application will consider (among other things):
- The prepared Clinical study protocol that is to be submitted or has been submitted to the IRB
- Whether this study is considered a significant risk device study
- Whether there is a potential for serious risk to health, safety or welfare of the subjects
- Whether the device is intended as an implant
- Whether the device is to be used in supporting or sustaining human life
- Whether it will provide substantial importance in:
- Diagnosing
- Curing
- Mitigating or treating a disease
- Preventing impairment of human health.
If this information satisfies the
FDA, then they will issue an IDE. However, if it is determined that this is
a non significant risk (NSR) investigated device and the study has IRB approval
and an appropriate informed consent, then there will be no need to obtain FDA
approval before the clincial study begins
Care has to be taken as to whether
the device is a combination product. What is a Combination Product? Under the
Safe Medical Device Act (1990) 503(g)(1), products that constitute a combination
of a drug, device or biologic, for example, combine:
- Drug and Device
- Device and Biologic
- Biologic and Drug
- Drug and Device and Biologic
Please note that a Drug – Drug
or Device - Device combination are not included here.
The combination products create regulatory complexity with a whole list of "acronyms" such as CDRH, CDER, CBER, NDA, BLA, IND and a whole different FDA review process. Some real world examples of these products include:
- Drug-eluting stent CDRH
- Drug-eluting disc (oncology) CDER
- Contact lens/glaucoma drug CDER
- Contact lens/glaucoma drug (new submission) CDER
- Spinal fusion device/therapeutic protein CDRH
- Chemo drug/monoclonal antibody CDER
- Scaffold seeded with autologous cells CBER
- Interferon/Ribivarin therapy CDER
- Embolization implant device/chemo drug CDRH
- Vertobroplasty device/analgesic CDRH
However, let us confine our discussion to the PMA. Once the trial data
has been obtained and compiled, the PMA is, like the 510(k), subitted to the
FDA for their review.. The review process may involve severa;l rounds of requests
for additional information and after it is satisfied, the FDA will issue an
order granting marketing clearance which means that the device can be legally
marketed for its intended use (label). This is a major milestone to achieve
and even more difficult than through the 510(k) process.
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