Q.01

How do I search the FDA clearance database?

You don't run a separate search screen. You ask your question in plain language from the RegAffairs AI landing page, and you get a cited answer with the research trail (searches run, documents read) shown on the page.

Getting good results for FDA clearance questions

  • Be specific. Questions work best when they name the product, the instrument and the jurisdiction. For a clearance, give the device or product name, the manufacturer, or the clearance number if you have it.
  • Expect pinpoint citations. Each claim links to the exact record or paragraph it came from. If the record has nothing on your question, the answer says so and names the list and version it searched.
  • Ask follow-ups in the same thread to narrow the results, for example by date, product type or manufacturer. Each follow-up counts as one question. Opening sources or expanding the research trail doesn't count.

Checking that FDA clearances are covered The user manual doesn't name an FDA clearance database specifically. Its eight industries are Pharma, Food, ESH, Chemicals, Pesticides, Fashion, Cosmetics and Biocides, and medical devices isn't one of them. The Coverage page breaks coverage down by industry and jurisdiction, so you can confirm there. If the source is missing, you can request it on that page or at hello@regaffairsai.com.

Other ways to search

If you send me a device name or clearance number, I'll run the search now.

Source: RegAffairs AI user manual

Q.02

Which devices are exempt from premarket notification?

The FDA device classification database lists 2,639 product codes as "510(K) Exempt": 2,155 are Class I and 484 are Class II. I've put every one in the panel document, grouped by review panel, with product code, device name, class, 21 CFR regulation number and any limit FDA places on that product code's exemption.

How it breaks down by review panel: Clinical Chemistry 286, Microbiology 253, General & Plastic Surgery 236, Pathology 232, Ophthalmic 196, Dental 191, Ear Nose & Throat 160, Gastroenterology/Urology 157, Physical Medicine 155, General Hospital 145, Hematology 99, Immunology 82, Radiology 81, Anesthesiology 76, Toxicology 74, Orthopedic 70, Obstetrics/Gynecology 63, Neurology 48, Cardiovascular 33, Molecular Genetics 2.

Exemption depends on conditions in some cases. 27 product codes describe their exemption as subject to limitations. For example, some are the exempt Class II counterpart of a product code that still needs a 510(k). These were exempted under the 21st Century Cures Act procedures. They "do not require premarket notification (510(k)) to market if [they do] not exceed the general limitations of exemption found in 21 CFR 8xx.9" and the product-specific limit in the record. Three examples:

  • Tympanometer, Exempt (PTP), 21 CFR 874.1090: exemption only covers tympanometers that meet the FDA-recognised consensus standard ANSI S3.39 [1].
  • Drape, Surgical, Exempt (PUI), 21 CFR 878.4370: exemption only covers surgical drapes that do not contain an antimicrobial agent [2].
  • Ocular Peg, Exempt (PUF), 21 CFR 886.3320: exemption only covers ocular pegs supplied sterile [3].

A device can be exempt from 510(k) and still be subject to GMP requirements. 530 of the exempt product codes are also GMP-exempt and 2,109 are not. Manual algesimeter (BXL, Class I, 21 CFR 868.1030) is one that is both 510(k)-exempt and GMP-exempt [4].

Don't confuse this list with "HDE – Humanitarian Device Exemption", which is a different submission type in the same database and isn't counted here.

Approach: I searched the FDA CDRH product classification database and took every product code whose submission type is "510(K) Exempt". I didn't pull the text of the general limitations of exemption (the ".9" section of each 21 CFR device part 862-892).

Q.03