Comment one, comment all! As part of FDA’s ongoing effort to clarify the classification for medical device accessories (see our previous posts here, here, and here), on August 17, 2018, FDA issued a notification requesting comments on a proposed list of accessories that FDA believes are suitable for classification in Class I, separate from their higher-classification parent device.
As mentioned in our previous posts, FDA’s approach to classifying medical device accessories has led to a confusing regulatory scheme in which some accessories are being over-regulated because they were classified according to the parent device (which may be riskier than the accessory) while other accessories have their own separate classification regulations.
In order to further clarify classification of accessories, on August 18, 2017, section 707 of the FDA Reauthorization Act of 2017 (FDARA; Pub. L. 115-52) amended section 513(f) of the Federal Food, Drug, and Cosmetic Act (FDC Act) and, among other amendments, created a process for FDA to reclassify certain accessories, including proposing a list of accessories suitable for distinct classification into Class I. In accordance with the procedures established by FDARA, FDA published the notification that includes an initial list of eight accessories that the Agency believes are suitable for Class I and is seeking public comment. These eight accessory types are: (1) gastroenterology-urology accessories to a biopsy instrument; (2) penile implant surgical accessories; (3) ureteral stent accessories; (4) biliary stent, drain, and dilator accessories; (5) suprapubic catheter accessories; (6) implanted mechanical/hydraulic urinary continence device surgical accessories; (7) air-handling apparatus accessory; and (8) corneal inlay inserter handle.
FDA mentions that it considered accessory types appropriate for inclusion on this list if:
- they are not for use in supporting or sustaining human life, or of substantial importance in preventing impairment in human health;
- they do not represent a potential unreasonable risk of illness or injury; and
- general controls alone would be sufficient to provide a reasonable assurance of safety and effectiveness of the accessory (e.g., design controls are not required).
The Agency’s notification states that it is open to considering additional accessory types that meet the criteria above and interested parties should comment with their recommendations and rationales for inclusion on the final list.
FDA’s notification also, separately and somewhat unrelated to the proposed list, clarifies its policy regarding orthopedic manual surgical instruments that are appropriately classified as Class I pursuant to 21 C.F.R. § 888.4540. According to the Federal Register notice, instruments that are designed for use with a specific orthopedic implant are generally accessories to the parent device, not Class I orthopedic manual surgical instruments. In addition, FDA states that these implant-specific instruments are typically included in the same premarket submission as the parent device (e.g., 510(k) or PMA). On the other hand, FDA considers orthopedic manual surgical instruments to be those that are for “general use” apparently meaning that they are capable of use with more than one implant type. FDA’s rationale appears based, in part, on the fact that the implant-specific instruments should be subject to design controls to ensure they are safe and effective for use with the parent device (e.g., orthopedic implant). Therefore, they would not be eligible for Class I.
This policy appears to be more than a mere “clarification,” and those in the orthopedic implant and instrument market will want to carefully consider their current instrument classification. According to FDA’s policy, there are now three types of orthopedic manual surgical instruments: (1) those that are appropriately classified under 21 C.F.R. § 888.4540 because they are for “general use;” (2) those that were included in a parent-device premarket submission and are appropriately Class II or III consistent with the parent device classification; and (3) those that were included in a parent-device premarket submission but may be over-regulated based on the parent device’s classification.
With regard to this third group, companies have two options:
- Comment on FDA’s proposed list to recommend adding such instruments to FDA’s final list of Class I accessories. Any proposal should include a clear justification for why the proposed accessory type meets the criteria for Class I.
- Request separate accessory classification of such instruments via section 513(f)(6)(D) of the FD&C Act.
Going forward, if an orthopedic company has a new instrument that will be referenced in a parent-device premarket submission, the company can request classification of the instrument separately from the parent device in the parent device’s 510(k) or PMA in accordance with section 513(f)(6)(C) of the FD&C Act (as described in FDA’s accessory classification guidance).
The comment period on the proposal ends on October 16, 2018. In addition to comment on FDA’s proposed list of Class I accessories, companies should feel open to commenting on FDA’s policy regarding orthopedic manual surgical instrument.