Orthopaedic Device Forum
Meeting Summation Report
October 4-5, 1998
Rockville, MD

Present:

The Forum members reviewed, amended, and approved the summation report from the July 1998 meeting of the Orthopaedic Device Forum.

Phase II June 1998

Phase III August -September 1998

Within one year of the FDAMA proposal, Congress has mandated that Phase III needs to be in action. The pilot program was not a success, but Congress mandated that FDA had to implement the act.

The general to specific paradigm had to be implemented within one year. No new legislation is planned.

Three Different Submissions

1. Traditional Standard 510K, Clinical, Preclinical, (Bulk of the work)

2. Abbreviated Fairly successful

3. Special Not a significant change in the orthopaedic area, modifications to existing devices (take the burden off of the program). Declare conformity to QSR & DC in 30 days.

The Orthopaedics branch has made the most dramatic increases in decreasing review times. The FDA is becoming comfortable with the 510K program and the Orthopaedic Device Forum can be credited with having had an influence on that. Previously, reclassifications were not successful.

Members questioned when the FDA starts the clocks for the 90-110 day review period. The average review time usually runs 60 days. FDA tracks review times as such:

1. Average FDA days

2. Average total days (Total FDA and Industry)

3. Average number of cycles

It was noted that a recall is different than withdrawal of approval or recision. There are very few FDA mandated recalls and very few withdrawals of approval. The manufacturer usually makes the decision to take the device off of the market. Often times, the marketplace takes care of efficacy itself. The FDA abbreviated process will monitor with postmarket trends.

In working with the Swedish hip registry, variation is wide. The variations may not have anything to with a successful design rather; there are economic explanations. Long term data for devices is increasingly important. Usually, a surgeon is concerned with a 10 year window. In reality it’s not feasible to do a double blind study for 20 years. Unfortunately, third party payors are not concerned about long term data.

It’s helpful to have delineated issues for the task force: the MDR aspect and the surveillance aspect. Both aspects, which are addressed with CDRH, need to be studied.

In order to receive designation as a Humanitarian Device Exemption (HDE) the FDA stipulates that you must be treating less than 4,000 people and there can not be a competing product. Regulations are always specific to devices. HDE’s do not have a specific safety requirement but, the manufacturer cannot make a profit on it. The HDE can be placed on the market for efficacy which removes non-FDA approved stigma for reimbursement. Example: Electrical stimulators for avascular necrosis.

Standards are continuous and ongoing. There are new standards now, possibly more in six months. The FDA expects changes to the external fixator regulations.

Treatment IDE (Investigational Device Exemption) is primarily associated with safety. If an IDE is approved it does not necessarily mean that the manufacturer is approved for reimbursement immediately. The insurance industry is controlled by HCFA decisions and the Forum cannot disregard the issue of payment. OSMA members, in the past, have had the experience that if any one element was experimental then, the entire procedure was not reimbursable.

The FDA has compiled a table for expanded access mechanisms for unapproved devices. Mechanisms include emergency use, compassionate use, treatment IDE, and continued access.

Guidance documents for industry are still in draft form and are distributed.

1. Spinal Clinical Studies
2. General/ Specific Intended Use

The Orthopaedic Device Forum mission statement was revised to the following:

The Operational Principles section was amended to:

The Orthopaedic Device Forum was established to permit regularly scheduled interactions among representatives of the scientific and clinical Orthopaedic Community, the FDA and other governmental agencies, and representatives of the industry related to musculoskeletal health and diseases. Such interactions are consistent with the intent of current federal law.

The Recognition Statement was changed slightly to:

In February of 1999, the Biological Implants and Biomedical Engineering Committees will have new chairmen. The current chair of the Device Forum and the AAOS board member have been reappointed for another year.

For liability issues, the general consensus is that the Forum should have a stand alone site with links to the ASTM, AAOS, ISO, and AOA.

The disclosure policy was drafted primarily for non-governmental personnel. From the FDA’s standpoint, everyone is conflicted. A suggestion was made that the disclosure statement could be placed on the bottom of the agenda so that Forum members would be aware of potential areas of conflict of interest. The AAOS Board of Directors will be consulted about the disclosure policy. Liability issues will be discussed with the general consul.

The summary of issues of the ORS workshop should be completed by the January Forum meeting.

2 guidance documents released for Biologicals :

"Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products"

New proteins, as well as, BMP are under development for use with orthopaedic devices. Manufacturers need to know what concerns the FDA has about the safety of proteins, particularly if they have used viral production methods. Products that are purified or partially purified from human fluids are also of concern.

"Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin"

The document is comprehensive and should be required reading, in the opinion of the cell biologist, for gene and cell therapists and anyone involved in tissue engineering.

Bone Growth Stimulators- The CDRH Orthopaedic Device Panel reviewed bone growth stimulators and provided the FDA with safety and effectiveness concerns for devices that produce ultrasound and electromagnetic stimulation.

Biologics documents can be sent to the Biological Implants committee for review at their next committee meeting. Considering the explosion of information, one committee does not necessarily have all the experts on it any longer. A more fluid arrangement of personnel seems to work better. For that reason, championing seems to be more effective than subcommittees. The cell biologist will be the "champion" for Biologics.

AAOS representatives are consulting with members of the cartilage repair workgroup to develop guidance. It would be helpful to have input from industry in development of guidance documents, particularly in terms of format.

OSMA has changed their bylaws so that biological companies may become members of OSMA. The biologics companies should not underrate the educational value of the Orthopedic Surgical Manufacturers Association. It was noted that total hip replacements were manufactured by industry for many years before standards were implemented.

Members are seeking candidates to work on the Device Panel; in particular, a greater percentage of female participation is sought.

The FDA is looking for personnel with the following qualities:

1. Associated with academic associations
2. Non-conflicted in a certain area
3. So conflicted in all areas that they must be an expert
4. Area of expertise appropriate (orthopaedics)
5. Demographics

The FDA wants to gather a huge consulting pool then will deputize an individual for certain review of products. Members are usually too conflicted on an advisory committee. If a conflict exists, candidates would need to have a balanced perspective even if they didn’t vote. The FDA does have a waiver process however; there are individuals who are so conflicted, they can’t receive a waiver.

The ASTM wanted recognition of the regulatory process. Ten people attended TC-150. AAOS traditionally supports two people to attend ISO. This year the Academy is sending three members.

It was suggested that those who attended ISO provide an executive summary. OSMA communicates regularly with the international community, as does the AOA. The International President’s Meeting is on Thurs. Feb. 4, 1999 at the AAOS annual meeting. The Board representative will speak to the International Committee chair to facilitate an inclusion on the agenda in order to identify personnel who might have an interest in working towards international standards.

All action items were completed since the last meeting. The FDA is considering down classifying metal from a Class III to a Class II device. ASTM will publish a document on down classification in spring. IDE’s were submitted for 4 companies which all have a metal on metal device.

A FDA representative discussed timing for Class III PMA’s:

Manufacturers can submit 510K’s until Pre Market Approval. There will be a 90-day comment period. Currently, there are no new 510K’s, which contain clinical data.

It is interesting to note that there have been no submissions for metal on metal hip replacements between 1976-1994.

Bench testing for devices is likely to be insufficient due to the fact that most devices are not going to fail within two years. Bearings do not falter within the two-year window. Thus, the clinical data that is compiled is a reflection of the design of the device.

Metal on metal data has not been available which would have led to reclassification.

Bearing continues to remain an issue, but failure of the device is not usually due to the bearing. Polyethylene is considered part of a component, not an entity unto itself. Articulations must also be considered.

Products can be submitted without clinical issues, most however are clinically driven.

FDA responds more positively to down classification if data is available. It was noted that a 510K with clinical data is not that much different than PMA’s.

The general consensus is that companies would be willing to submit data as a part of down classification. OSMA has decided to support down classification and would like to stay out of PMA’s since it is to their financial advantage to do so. Companies that pursue 510K’s have a more successful route than PMA’s.

Currently, there are no companies registered for surface replacement. Resurfacing will be discussed at future Forum meetings.

The symposium "Regulatory Aspects of Orthopaedics" was accepted and will be presented at the AAOS Annual Meeting on Thursday, February 4^th from 1-3pm.

All speakers should submit 1-½ pages for their topic. By the next meeting, a 10-page handout will be available. Speakers will present for 10 minutes each, to be followed by a 60-minute discussion period.

Additional Educational Initiatives include:

1. Biomedical Engineering and Hip & Knee Arthritis had two exhibits accepted
2. Four members of the Forum and the AAOS periodicals manager are working on a Journal article.
3. FDA Science Forum will be held on December 8-9, 1998

The labeling subcommittee presented long and short versions of proposed labels for total hip prostheses. As suggested at the last Forum meeting, the subcommittee redacted several manufacturers’ inserts for cemented total hips. It was decided to utilize the term "orthopaedic device labeling" rather than the term "generic labeling." The difference between Class III and II should be reflected in the labeling.

The content in the package inserts is very similar from manufacturer to manufacturer. Product specific claims can be included on patented materials but must have indications & contraindications. It was suggested that the term "absolute contraindications" not be used.

The intended medical use is important in labeling. However, in orthopaedics there is a much bigger issue than in other specialties due to the fact that there may be 10,000 line items in an orthopaedic manufacturers product catalogue. OSMA wants to develop one package insert, which would allow simplification for manufacturers.

Issues to address for Orthopaedic Device Labeling:

After discussion, it was suggested that there was need for the committee to further assess achievable goals.