Vague language and inconsistent interpretations of policy have hindered the Food and Drug Administration's (FDA) [website] ability to effectively evaluate and approve medical devices, according to a new FDA report [text, PDF] released Wednesday. A committee from the FDA's Center for Devices and Radiological Health (CDRH) [website], which regulates medical devices sold in the US, conducted the report to address concerns over whether the current 510(k) program, which oversees the approval of devices similar to those already approved, achieves its goals of "making safe and effective devices available to the public while fostering innovation." The committee recommended that language be improved to require producers of medical devices to submit more safety information to receive approval and be able to more easily revoke approval for products that prove to be unsafe or ineffective. The committee found that the FDA's unclear expectations of would-be medical devices are resulting in lax standards and avoidable complications:
With regard to informed decision making, the Working Group found that it is challenging for review staff to obtain, in an efficient and predictable manner, sufficient device information to make well-supported decisions. To obtain such information without creating unnecessary delays and burden, CDRH must provide submitters with as much up-front clarity as feasible about its evidentiary expectations.The Working Group therefore recommends that CDRH take steps to foster the submission of high-quality 510(k) device information, in part by better clarifying its expectations for 510(k) content.CDRH Director Jeffrey Shuren [official profile] said that his agency is ready to make the necessary improvements [press release] in order to "support device innovation while assuring patients receive safe and effective devices." CDRH has opened another public docket to receive additional comments on the report, which it will review before proposing any changes.
The CDRH established the staff committee last year. Since then, it has been reviewing input from public meetings, open dockets, data analyses, and input from CDRH staff to make the evaluation. Section 510(k) of the Food, Drug and Cosmetic Act [text] requires device manufacturers to notify FDA of their intent to market a medical device at least 90 days in advance, so the FDA can inspect and classify it.