FDA Admits to Error, Revises Exemption List

Citing an administrative error, the FDA has updated its list of medical device types that are exempt from premarket notification requirements.

The gaffe, according to an Aug. 14 Federal Register notice, occurred because agency staff failed to consider certain comments before issuing final guidance (IDDM, July 6). Issued last month, the guidance document exempted product codes for certain unclassified, Class I and Class II medical devices that are well understood and don’t require premarket submissions to ensure their safety and effectiveness.

Among the devices named in the document were certain oscillometers, teething rings and medical support stockings.

A draft version of the guidance came out in August 2014, with a comment period closing Sept. 30. After receiving 55 comments, the FDA took a number under advisement.

For example, it added product code OYS, patient bed with canopy or restraints, among other revisions.

As it finalized the guidance, the agency also identified an additional 15 device types for the list. While some of the comments mentioned codes were not reviewable by the Center for Devices and Radiological Health, others mentioned conformance to recognized standards — something that goes beyond the scope of the guidance.

Rectifying Error

The agency eventually determined it had not taken some comments into consideration, leading to the addition of eight codes.

Newly added to the exemption list are:

• DTL — adaptor, stopcock, manifold, fitting, cardiopulmonary bypass;
• OCY — endoscopic guidewire, gastroenterology-urology;
• KOE — dilator urethral;
• FTA — light, surgical, accessories;
• GZM — analyzer, rigidity;
• GZO — device, galvanic skin response measurement;
• HCJ — device, skin potential measurement; and
• HLJ — ophthalmoscope, battery-powered.

Interested parties may comment on the guidance at any time.

Read the Federal Register notice at www.fdanews.com/081715-update-guidance-list.pdf. To view the updated guidance document, visit www.fdanews.com/081715-guidance-exempt.pdf. — Elizabeth Hollis