Grapefruit USA Inc (GPFT)

[TASHI]

Seems to me that the information provided by the yahoo posting adds some things that are not related to the Dominion. I don't think there's an issue with the classification of this device and it doesn't seem to me that the software involved would contribute to this prolonged process.

I guess the waiting period causes most, including me, to view thing that may not be there... If one approaches a subject from many directions, it's easy to come up with a multitude of scenarios.

The 510k was filed for the Dominion, I believe, as a Class II device. So, I'm not sure how Class III got into the picture. If we don't have a Class III, then there's no PMA.

The recent post also had an issue with the Dominion's software. It seems that the software would add another segment to this process. I'm not sure that the Dominion's software will be looked at separately. I believe there's only one complete device the FDA is studying in this approval process.

I also believe that a great amount of work has been done in keeping up with the FDA's rules, regulations, red tape, etc. At this stage (IDE) of the process (or ordeal, take your pick), I just don't see this being much more prolonged.

A few weeks ago, I read someone forecasting this process dragging on until after the November elections. Not sure about this forecast regarding the FDA and politics. Anything is possible, but this doesn't seem probable.

I pulled some information from the web (not an FDA site) in order to reacquaint myself with the FDA classifications. I wanted a different perspective than the FDA since their website is probably designed to confuse the reader.

http://abhishekkatiyar.wordpress.com/2008/07/16/overview-fda-regulation-of-medical-devices/

"Class II medical devices are devices where General Controls are not sufficient to assure safety and effectiveness and existing methods/standards/guidance documents are available to provide assurances of safety and effectiveness. In addition to compliance with General Controls, Class II devices are required to comply with Special Controls. Special Controls include:
• Special labeling requirements,
• Mandatory performance standards, both International and United States
• Postmarket surveillance
• FDA medical device specific guidance
Class II devices typically require pre-market notification by submission and FDA review of a 510(k) clearance to market submission. A few Class II devices are exempt from the premarket notification. Information on Class II exempt devices is located within the device regulation, 21 CFR 862 through 892. Examples of Class II devices include physiologic monitors, x-ray systems, gas analyzers, pumps, and surgical drapes.
Class III medical devices have the most stringent regulatory controls. For Class III medical devices, sufficient information is not available to assure safety and effectiveness through the application of General Controls and Special Controls. Class III devices usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient. Typically a Pre-Market Approval (PMA) submission to the FDA is required to allow marketing of a Class III medical device. A few Class III medical devices are required to only have a 510(k) cleared by the FDA to be marketed. Examples of Class III devices that require a PMA are: replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.
510(k) Clearance to Market
The majority of Class II medical devices are cleared to market by submission and FDA review of a 510(k) Pre-Market Notification submission. The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.
The information required in a 510(k) submission is defined 21 CFR 807.87. A 510(k) submission includes:
• Device trade or proprietary name, common or usual name or classification, Class of the device (Class I, II, III)
• Submitter’s name and address, Contact person, telephone number and fax number, Representative/Consultant if applicable
• Name and address of manufacturing/packaging/sterilization facilities, Registration number of each manufacturing facility
• Action taken to comply with the requirements of the Special Controls.
• Proposed labels, labeling, and advertisements to describe the device, its intended use, and the directions for its use.
• 510(k) summary or a 510(k) statement.
• For Class III medical device, a Class III certification and a Class III summary.
• Photographs of the device, Engineering drawings of the device.
• Identification of the marketed device(s) to which equivalence is claimed including labeling and description of the medical device.
• Statement of similarities and/or differences with marketed device(s)
• Data to show consequences and effects of a modified device, performance Data (bench, animal, clinical)
• Sterilization information (as applicable)
• Software development, verification and validation information
• Hardware design and development information
• Information requested in specific guidance documents (as applicable)
• Kit Certification Statement (for a 510(k) submission with kit components only)
• Truthful and Accurate Statement
Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 20 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer the FDA review process."

jmo...