On Aug 14, 2015 FDA updated the Final Guidance Document titled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements”.  It was originally issued as a Final Guidance on July 1, 2015.  The main change for this current revision was to add 8 product codes that were overlooked due to an administrative error where the FDA missed some comments from a public consultation.  Additionally, they added a couple important clarifications to the Guidance.

This Guidance describes the FDA’s intent to exempt the product codes mentioned in this Guidance of the unclassified medical devices, and Class II & I medical devices that are subject to section 510(l) of the FD&C Act, from premarket notification requirements.  The FDA believes devices identified in this Guidance document (Section IV) are well understood & don’t require premarket notification (510(k)) to assure their safety & effectiveness.  So, the FDA intends to propose exempting these devices from premarket notification requirements of section 510(l) & (m) of the FD&C Act, subject to limitations on exemption criteria in a slew of 21 CFR sections in the 868.9 to 890.9 range (refer to Guidance for details).  When FDA publishes such a proposal it will be published in the Federal Register but until the publication of a final rule or order exempting these devices from 510(k), the FDA doesn’t intend to enforce compliance with 510(k) requirements for these identified devices.  Therefore, the FDA doesn’t expect manufacturers to submit 510(k)s for these devices during this time period.

The 2 clarifications are: 1) It is not FDA’s intent to exempt any combination products that fall under the list of product codes that are subjected to this Guidance Document.  2) The product codes mentioned in the Guidance that contain an antimicrobial agent are not within the scope of this Guidance.

The product codes added to the latest version of the Guidance include:

• DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass – (classified under 21 CFR 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting)
• OCY – Endoscopic Guidewire, Gastroenterology-urology – (classified under 21 CFR 876.1500 Endoscope and accessories)
• KOE – Dilator, Urethral – (classified under 21 CFR 876.5520 Urethral dilator)
• FTA – Light, Surgical, Accessories – (classified under 21 CFR 878.4580 Surgical lamp)
•  GZM – Analyzer, Rigidity – (classified under 21 CFR 882.1020 Rigidity analyzer)
• GZO – Device, Galvanic Skin Response Measurement – (classified under 21 CFR 882.1540 Galvanic skin response measurement device)
• HCJ – Device, Skin Potential Measurement – (classified under 21 CFR 882.1560 Skin potential measurement device)
• HLJ – Ophthalmoscope, Battery-powered – (classified under 21 CFR 886.1570 Ophthalmoscope)

The product codes that were updated include:

•  MRQ – Analyzer, Nitrogen Dioxide – (classified under 21 CFR 868.2385 Nitrogen dioxide analyzer).  The change was to add the following text: “This intention only applies to stand-alone devices and not those that are components of nitric oxide delivery systems used to monitor nitrogen dioxide levels during inhaled nitric oxide therapy.”
• KKX – Drape, Surgical – (classified under 21 CFR 878.4370 Surgical drape and drape accessories).  The change was to add the following text: “This intention does not apply to devices including an antimicrobial agent.”

If you need help in determining if your products needs a 510(k) premarket notification or a Premarket Approval (PMA) or to help prepare your documentation for FDA approval, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

In the Federal Register Notice the FDA said “The agency believes that this wil allow adequate time for interested persons to submit comments without significantly delaying action by the agency.”

Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’ It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that’s already won 510(k) clearance.”