Sentence examples for premarket clearance from inspiring English sources

These products are primarily considered Class II Medical Devices subject to premarket clearance requirements, most times requiring a 510(k).

The agency has announced it has asked a committee established by the National Academy of Sciences to review the general premarket clearance process for medical devices.

If an HCT/P does not meet the criteria set forth in 21 CFR 1271.10(a), and the establishment that manufactures the HCT/P does not qualify for any of the exceptions listed in 21 CFR 1271.15, then the HCT/P will be regulated under section 351 of the PHS Act and will require premarket clearance or a valid marketing license as a drug, biologic, or medical device.

Problems encountered by manufacturers with regard to premarket approval clearance and material supply quality standards assurance are discussed, as well as issues increasingly arising when one biotextile-based medical device is evolved into another for a different use.

The F.D.A. last year granted 19 premarket approvals — the type of clearance required for the most highly regulated devices — down from 48 in 2000.

In order for their products to be sold on store shelves, lube companies must obtain what's called premarket notification or 510(k) clearance, a process that requires a comprehensive round of safety testing.

Because mammography was used clinically prior to the Medical Device Amendments (MDA) of 1976, analog (film screen) mammography did not receive FDA premarket approval or 510(k) clearance.

Since the ECAT II system was introduced before implementation of the 1976 MDA, it was marketed without FDA premarket approval or 510(k) clearance.

Premarket submissions for such devices are sometimes referred to as "envelope" submissions because their approval or clearance covers the entire range of specifications data they contain to support.

They were up 2percentt in premarket trade.

JPMorgan stock was up 58 cents at $42.68 in premarket trading.