Under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), each person who proposes to introduce a device, is required to submit a Premarket Notification 510(k) to the FDA at least 90 days before commercial distribution begins.
A submitter may choose from three types of Premarket Notification 510(k) submissions to seek marketing clearance for their device when appropriate for review: Traditional, Special, and Abbreviated.
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A Premarket Notification is a submission made to the U.S. Food and Drug Administration by a medical device manufacturer to demonstrate that the device to be marketed is substantially equivalent to another legally U.S. marketed device, and is as safe and effective. A claim of substantial equivalence does not mean the new and predicate devices needs to be identical.
The 510(k) submission includes information about the device’s intended use, design, and performance characteristics compared to a predicate device. This performance data can include clinical data and non-clinical bench performance data, including engineering performance testing, sterility, electromagnetic compatibility, software validation, biocompatibility evaluation.
Since October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR).
The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.
On the other hand, the National Personal Protective Technology Laboratory (NPPTL), is a subdivision of the National Institute for Occupational Safety and Health (NIOSH), that performs certification examination, inspection, and testing. The most common certification NPPTL performs is for N95 respirators and medical masks.
Applicants, manufacturers, or their representatives may communicate with NPPTL in order to discuss the requirements for approval of any respirator or the proposed designs thereof. No charge will be made for such consultation and no written report will be issued. However, fees will be charged for respirator certification application, approval, approval modification, records maintenance, and testing.
The FDA confirms that the respirator has a valid NIOSH certification number and therefore has met the particle filtration efficiency standards and other requirements.
Then the agency looks at whether the product also meets the biocompatibility, flammability, and fluid resistance standards and, if so, the product could be approved as a surgical N95 respirator.
If the surgical N95 respirator is proposed to have an antimicrobial additive, the FDA imposes additional requirements because of the concern that chemically attaching or embedding an antimicrobial could affect a filter’s barrier performance.
NIOSH does not issue a certification of a surgical N95 respirator, until the FDA confirms it is also reviewing the product.
Fluid resistance is one of the elements that is assessed in FDA’s Premarket Notification 510(k) approval process for surgical N95 respirators.
Testing of respirators to meet the FDA criteria for fluid resistance is usually done using the ASTM F1862 test method standard, which assesses whether the synthetic blood penetrates into the layers of the respirator. The test involves dispensing synthetic blood using a pressurized cannula for a distance of 12 inches through a small hole in a target plate to which the respirator is attached. A visual inspection of the inside of the respirator for fluid penetration is then conducted.
The agency also recognizes ASTM F2100 as the consensus standard for performance specifications of the materials used in respirators and medical face masks.
Registration of a device establishment (which is required annually), assignment of a registration number, or listing of a medical device, does not in any way denote approval of the establishment or its products by the FDA.
Comply with FDA regulatory Establishment Registration and Device Listing.
When you seek and request the assistance of an FDA Consultant or U.S. Agent, such as ITB HOLDINGS LLC, an additional Service Fee will be due.