Vol.5, No.1

January 2000

FDA Classifies Plagiocephaly Helmets

Thomas V. DiBello, CO
Academy President-Elect

Cranial molding helmets have received a Class II medical device designation from the Food and Drug Administration. The implication of this classification is that only devices approved by the FDA may be used to treat deformational plagiocephaly. Currently, the Dynamic Orthotic Cranioplasty Band (DOC™ Band) manufactured by Cranial Technologies, Inc., of Phoenix, is the only such device approved by the FDA. Therefore, all practitioners who are currently making these types of orthoses should be aware of this development.

The Academy is not suggesting any particular course of action at this time and considers this announcement to be informational only. A definitive course of action may be recommended in the future. Below is the wording found in the Federal Register pertaining to this issue.

(Selected text from the Federal Register, Vol. 63, No. 146.)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

21 CFR Part 882
(Docket No. 98N-0513)
Medical Devices; Neurological Devices; Classification of Cranial Orthosis
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.

SUMMARY: The [FDA] is classifying the cranial orthosis into class II (special controls). The special controls that will apply to the cranial orthosis are restriction to prescription use, biocompatibility testing, and certain labeling requirements. The agency is taking this action in response to a petition submitted under the Federal, Food, Drug, and Cosmetic Act (the act)…The agency is classifying cranial orthosis into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

EFFECTIVE DATE: August 31, 1998.

SUPPLEMENTARY INFORMATION

1. Background

In accordance with section 513(f)(1) of the act, FDA issued an order on March 12, 1998, classifying the Dynamic Orthotic Cranioplasty (DOCTM Band) in class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On March 31, 1998, Cranial Technologies, Inc., submitted a petition requesting classification of the DOCTM Band under section 513(f)(2) of the act. The manufacturer recommended that the device be classified into class II.

The device is assigned the generic name "cranial orthosis," and it is identified as a device intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.

San Diego Meeting Packed with PCE Credits

By now, Academy members have received their Preliminary Program for the Annual Meeting, March 15-18 in San Diego. (The Preliminary Program is also available on the Academy's website at www.oandp.org/academy2000 - and you can register online.)

More than 60 topic areas will be presented totaling 32 PCE credits (some occur concurrently). Participants will be able to accumulate between 22 and 24 credits with another 3 PCE credits earned by visiting the exhibit hall. (ABC limits Class II PCE credits from exhibit hall visits to 3 in one year.)

Practitioners will enjoy the variety of topics and formats at the San Diego meeting. These include symposia, instructional courses, Thranhardt finalists' presentations, Society Select Presentations, certificate program modules, technician programs, technical workshops presented by manufacturers, and free papers. In addition, there will be sessions on professional development to help improve the individual practitioner's ability to manage time, practice, and money.

Members will also save money this year because the closing Gala Celebration on Friday night is now included in the full registration fee.

Another added value is the handsome legal pad portfolio that will await full registrants who register before January 31.

Registration forms may be returned online or faxed to ExpoTrac at 401-765-6677. For additional registration forms, go to www.oandp.org or call Tracy at 703-836-7118.

7 Changes at the Academy

In case you haven't noticed, here are some of the things that have changed in the last year.

1. More Issues of the Academician - What started as a quarterly publication is now published 10 times each year bringing you the latest reliable information on what's happening in the Academy.

2. More Special Reports - NCOPE's Residency Programs now require students to complete a research project. Members will receive three to five of the best of these each year as part of The Best of the Resident Research Series. Members also receive The Best of the Thranhardt Lecture Series, reproducing the lectures of the Thranhardt Award recipients presented at the Annual Meeting.

3. Techs Can Be Members - The Affiliate Member category established in 1998 now has 178 ABC-registered technicians and associates as members. In addition to their member benefits, Affiliate Members are also entitled to vote and hold office in the Scientific Societies.

4. New Society Started - To meet the needs of individuals who work directly with materials, the Fabrication Sciences Society was formed in 1999.

5. Your Dues Haven't Increased in 6 Years - And won't increase in 2000 either! That's good news for everyone.

6. Committees Don't Meet In Person - What once was the old face-to-face meeting is now a thing of the past. Almost all of the Academy's committees, councils and task forces meet by phone or email. If you're interested in being part of this respected group of volunteers and can devote a small amount of time once or twice during the year, let your interest be known. Email Tom Gorski, Executive Director, at tgorski@oandp.org.

7. JPO Is Online - Ten years of back issues of the JPO have been placed on the Academy website, and it is the most popular site visited. See it at www.oandp.org/jpo. Beginning in 2000, the prestigious publishing house Lippincott Williams & Wilkins, which also produces Spine magazine among other professional journals, will provide production services for the JPO.

Calendar of Events

January:
17 Academy offices closed
30-1 AOPA Policy Forum

February:
21 Academy offices closed

March:
15-18 Academy Annual Meeting & Scientific Symposium, San Diego, CA
31-1 Spring EPS, Chicago, IL