Responsibility for reviewing respiratory device-related premarket submissions is expected to be transferred out of FDA's Division of Cardiovascular and Respiratory Devices (DCRD) to the Division of Dental, Infection Control and General Hospital Use Devices (DDIGD).

FDA Center for Devices and Radiological Health's Office of Device Evaluation staffers explain that the move is intended to help achieve greater parity in the work levels among ODE's six divisions.

A timeframe for the switch has not yet been finalized, agency officials note. Although it is not expected to object to the transfer, the National Treasury Employees Union likely will play a role in negotiating details related to the move. Non-supervisory FDA employees voted to form chapters and join the union in April 1998 (¹ Also see "FDA goes union" - Medtech Insight, 13 July, 1998.). FDA has yet to formally notify the union of the impending switch, union reps say.

Respiratory submissions currently are handled by DCRD's Anesthesiology and Defibrillators Devices Branch. While some reviewers will be re-deployed to the device center's dental division, others will remain in the cardiovascular group in order to help that office keep pace with a growing number of premarket approval application, PMA supplement and investigational device exemption requests.

Respiratory devices will be the second product type in recent years to be moved out of DCRD. In 1997, review of neurological devices was transferred from that division to the Division of General and Restorative Devices (² Also see "In Brief: FDA's Division of General and Restorative Devices" - Medtech Insight, 1 December, 1997.).

ODE has had some more recent experience making these types of transfers. In March, the office moved the review of ear, nose and throat devices out of the Division of Reproductive, Abdominal, ENT and Radiological Devices (DRAERD) and into the Division of Ophthalmic Devices. Some DRAERD reviewers were transferred to the ophthalmic division. That switch likewise was prompted by a need to equalize the distribution of work within ODE, staffers explain.

DCRD's workload continues to tilt toward greater numbers of more time-consuming and resource-intensive PMA, PMA supplement and IDE submissions, while 510(k) receipts are on the decline, Donna-Bea Tillman, chief of the division's Pacing and Electrophysiology Devices Branch, observed at the recent Health Industry Manufacturers Association's "Device Submissions Workshop" in McLean, Virginia.

Although the division comprises roughly 20% of ODE's workforce, between July 1998 and July 1999 the Pacing and Electrophysiology office received approximately 50% of the total number of PMAs and PMA supplements, 43% of IDE applications and 15% of 510(k)s, according to Tillman.

For the same period, the division received 16 original PMAs, 260 PMA supplements and 682 amendments. Original IDE submissions to the division totaled 114; 1,881 IDE supplements and 107 amendments also were received. Original 510(k)s totaled 566, and an additional 402 premarket notification supplements arrived during the year.

As for the division's review times, original PMAs were completed in an average of 274 days, while supplements averaged 92 days, Tillman reported. 510(k)s took on average slightly over 100 days to complete, she noted.

Compared to DCRD, the dental division tends to receive more 510(k)s and fewer PMAs. For its part, DDIGD received 878 original and 351 supplemental 510(k)s in 1998, while averaging 75 days of FDA review time, Division Director Tim Ulatowski reported at the HIMA meeting.

So far in 1999, the division has logged 475 original and 177 supplemental 510(k)s while averaging 72 days of FDA review time. The division received five original PMA submissions in 1998 and the same number to date in 1999. PMA supplements totaled 12 in 1998 and nine so far this year.

Tillman noted that FDA is planning to recognize additional performance standards in order to increase the number of cardiovascular devices eligible for abbreviated 510(k)s. Likely candidates include American National Standards Institute/Association for the Advancement of Medical Instrumentation standards EC 11, EC 13 and EC 38, which cover cardiac monitors, holter monitors and ambulatory electrocardiograph devices, agency staffers say.

Respiratory Device Hand-off To FDA Dental Group Intended To Achieve Parity

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