Medical Devices; Investigational Device Exemptions
fda-device · Food and Drug Administration · Rule · Published 1998-11-23 · Effective 1999-02-22 · 63 FR 64617
Document
Document number
98-31245
Federal Register citation
63 FR 64617
CFR reference
21 CFR 812
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-11-23
Effective date
1999-02-22
HHS docket
Docket No. 98N-0394
Abstract
The Food and Drug Administration (FDA) is amending the Investigational Device Exemptions (IDE) regulation. The regulatory changes are intended to reflect amendments to the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA). These amendments provide that the sponsor of an IDE may modify the device and/or clinical protocol, without approval of a new application or supplemental application, if the modifications meet certain criteria and if notice is provided to FDA within 5 days of making the change. The rule also defines the credible information to be used by sponsors to determine if the criteria are met.