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FDA and O&P

FDA and O&P

Which rules set forth by the U.S. Food & Drug Administration apply to O&P businesses?

By Thomas F. Fise, JD

Before we begin, let’s conduct a quick test of your current knowledge

about the U.S. Food & Drug Administration (FDA), and how it does and can impact the activities of O&P facilities that fall within the law. Take the following True/False quiz:

1. All O&P devices are Class I, and, therefore, good manufacturing practices (GMPs) do not apply to any manufacturer, distributor, or patient-care facility that might be inspected by FDA.

TRUE

FALSE

2. FDA is required to notify you in advance to clear a date for inspection.TRUE

FALSE

3. Devices that have qualified for exemption from the GMP/quality system regulations (QSRs) of 21 CFR, Part 820, are the only O&P devices that are completely exempted from the unique device identifier (UDI) rules.

TRUE

FALSE

4. An O&P patient-care facility that does not operate central fabrication facilities for others is not required to register with FDA.

TRUE

FALSE

5. Any entity that serves as the initial U.S. distributor of imported medical devices can expect that FDA will hold it to the same responsibilities that would apply if it were the manufacturer of the device.

TRUE

FALSE

Now that you have completed the quiz, let’s discuss some important topics regarding how FDA regulations may affect O&P companies.

Good Manufacturing Practices O&P professionals may wonder, “Does my business have any responsibility to meet FDA requirements on manufacturers, such as GMPs?”

This is an important question and determines how deeply your company should be focused on FDA matters. The answer should be—and used to be—an easy one. The current answer is somewhat more complicated due to some changes relevant to O&P businesses as well as changes regarding how aggressively FDA is seeking to assert its authority. Here are some guidelines.

Generally, O&P suppliers, being those who actually make the components and raw materials that are used in devices furnished to patients in O&P care, are manufacturers, which must register with FDA, list their devices, meet GMPs for any devices they make to which those GMPs apply, and be subject to FDA reporting and recordkeeping guidelines.

Distributors, which sell devices— from off-the-shelf (OTS) orthotics to components of custom-fabricated orthotics and prosthetics—are generally not considered manufacturers unless one or both of the following are true:

1. They are the initial U.S. distributors of medical devices that originate outside the United States (or perhaps private labelers); and/or

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2. They engage in some activity in fabrication that FDA considers to be manufacturing.

Retail orthotic and prosthetic facilities do not need to register with FDA or provide annual listings of devices, provided that what they do is limited to providing patient care. Even though the regulations in 21 CFR 870.65(i) state that “retail orthotic and prosthetic facilities” are not required to register with FDA, this does not absolutely mean that a patient-care facility will not be considered by FDA as being a manufacturer. It really depends on what happens in that facility. FDA has recently conducted inspections claiming that facilities that engage in central fabrication activities are manufacturers, even though those facilities also may offer patient care. If the FDA makes that claim stick legally— a question that is not yet resolved—then it would expect such fabrication facilities to meet GMPs as to products to which GMPs apply, and be subject to all FDA reporting and record-keeping obligations imposed on traditional manufacturers.

So, if your company only provides patient care, then you can feel relatively safe in not being required to either

register with FDA or comply with GMPs, and/or meet full record-keeping requirements. You may be required to maintain complaint records, report device deficiencies/patient injuries, etc., to provide to FDA upon request, and to assist with any FDA recalls. You will nonetheless want to consider some items below, such as what to do when the inspector calls and how to establish a sample company policy on inspections.

If you have a central fabrication operation in addition to patient care (and the more sophisticated your lab facilities are, the more likely it is that FDA might assert that those facilities make you subject to manufacturer controls), you are now in a gray area. We cannot ignore that FDA has inspected some of these facilities and treated them as manufacturers, and expected them to meet the full range of manufacturer obligations above, including meeting GMPs and full FDA reporting and record-keeping guidelines. The responsibilities surrounding central fabrication are still not absolutely clear, but the following will serve as some general markers: 1. If you are a patient-care facility and you run a central fab, just for your patients, either on the site of, or

relatively close to, your patient-care office, you are unlikely to be deemed a manufacturer by FDA.

2. If you are a patient-care facility and you run a central fab, for your patients and for patients from other practices, there is a decent chance FDA will see that as a manufacturing operation.

3. The further removed your central fab for your patients is from your patient-care facility, the more likely that FDA will see that as a separate manufacturing facility, distinct from your patient-care facility.

4. If you are a manufacturer that runs a central fab facility, you can be virtually certain that the central fab will be considered by FDA as a full-fledged manufacturing facility.

FDA and 3-D Printing On May 10, 2016, FDA released Technical Considerations for Additive-Manufactured Devices: Draft Guidance for Industry and Food and Drug Administration Staff. The publication of this document marked the first foray of the FDA into potential regulation of devices that use additive manufacturing as a means of fabrication of medical devices. Additive manufacturing is a broad term that encompasses 3-D printing as a means of creating functional medical devices. The guidance document has been published in order to solicit public comment regarding the FDA’s current thinking on the topic of 3-D printing and “is not intended to be a binding document on either the FDA or the public.”

It is clear from this FDA notice that whatever rules apply to traditional O&P devices will also apply to similar devices fabricated using 3-D techniques and introduced for sale/commerce. So, while FDA does grant exemptions on both premarket notification (510k) and from GMPs/QSRs, it is important to note that FDA continues to require manufacturers of all Class I devices to register with the FDA through its device establishment registration process.

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While some Class I O&P devices have been designated as not being subject to more rigid regulation, such as the 510(k) premarket notification process and complete compliance with all aspects of GMPs, virtually no one is exempted from complaint record rules under the GMPs, and failure to comply with the record-keeping and complaint file requirements could lead to trouble for both traditional O&P manufacturers and those that incorporate 3-D printing into their manufacturing process. The complete document may be viewed at bit.ly/additivedevices.

UDI Final Regulations On September 20, FDA issued a final rule for a new UDI system, which FDA believes will provide a consistent way to identify, and potentially recall, medical devices after they are in commercial distribution. FDA received a specific statutory charge from Congress to implement this system, which has been in the works for several years and evolves from a proposed rule published in July 2012.

FDA has prioritized both the applicability of the UDI regulations, as well as the compliance dates, based on the levels of risk associated with devices. Higherrisk devices have less time before they need to be in compliance. The regulations include exceptions from the UDI rule: 1. FDA is granting an exception [Section 801.30(a)(2] from the specific rules applicable to the UDI as to medical devices classified in Class I, and as to which FDA also has granted exemptions from GMP/QSR regulations. Many O&P devices will have the benefit of this exception—you will find a specific listing of devices within the FDA Physical Medicine Devices grouping under 21 CFR Section 890 that FDA has exempted from GMP/QSR regulations, and which therefore also are granted the exception from the UDI.

2. Because there are some O&P devices that are assigned to FDA’s Class I,

On September 20, FDA issued a final rule for a new UDI system, which FDA believes will provide a consistent way to identify, and potentially recall, medical devices after they are in commercial distribution.

but which have not received an FDA exemption from GMP/QSR regulations, device manufacturers also will be very interested in Section 801.40(d), which has been amended to provide “that a Class I device that bears a UPC (universal product code) on its label and device packages and is deemed to meet all UDI labeling requirements and that the UPC will serve as the UDI required by Section 801.20. This grants exceptions for a Class I device with a UPC on its label and packages from UDI labeling requirements, regardless of to whom or through what channels it is sold. … The labeler of such a device is still required to submit data concerning the device to the Global Unique Device Identification Database (GUDID), unless the UPC device also qualifies for the exemption under Section 801.30(a)(2) as a Class I GMP exempt device.”

Regarding compliance dates, it is possible, in theory, that there are O&P devices that: (a) are not exempted from GMP/QSR regulations, and (b) where labeling does not bear a UPC, and which therefore would be subject to UDI, which also would apply to devices falling into FDA Class II or Class III. Here are the most relevant dates when compliance is required:

• Class II device — Sept. 24, 2018.

• Class I device — Sept. 24, 2020.

Initial U.S. Distributor and Private Labeling Liability FDA has prescribed that, to the extent that a distributor is the “initial U.S. distributor of an imported device,” that distributor is essentially treated as if it were the manufacturer in terms of FDA rules for registration, listing, GMPs, etc., being applied to these products. Similarly, if a U.S. company enters a private labeling agreement so devices manufactured by someone else are sold with your name on the package, you also are likely to be treated by FDA as the manufacturer. The idea is that if something goes wrong and the only label on the device carries your name, then you must be treated as if you were the manufacturer.

Purchasing Used Custom O&P Components Prosthetic and orthotic components are intended for use by certified and/ or licensed prosthetists and orthotists to build custom medical devices. AOPA is concerned about a growing number of instances in which prostheses (artificial limbs) and orthoses (orthopedic braces) are being resold—for example, sold as auction items on eBay. AOPA believes this practice is unfortunate, dangerous, and, in most cases, likely illegal.

Both manufacturers/suppliers and patient-care facilities have substantial concerns about how a medically unsupervised user of a used device impacts device warranties, malpractice coverage, FDA GMPs, and records and reports

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requirements. These devices may or may not be regulated by FDA and the 510(k) premarket notification process, and they should be limited to single-patient use.

In addition, this new methodology negatively affects device tracking for purposes of potential FDA or manufacturer recalls, compliance with physician prescription requirements by bodies that accredit O&P facilities, and the patientcare facility’s ability to assure that the component has never been used or delivered previously and has not been damaged in any way in the time between its departure from the manufacturer facility and its arrival at the patient-care facility.

Takeaways After reviewing the various rules and regulations above, O&P businesses should take away the following important information:

• O&P is not exempt from FDA.

• Manufacturers have responsibilities to register, file product listing and complaint reports, and quite possibly comply with GMP rules.

• Visit bit.ly/opfedregs to find out how an O&P device is classified (Class I, II, or III) and what the exemptions are.

• Get and use the AOPA FDA Compliance Manual.

• When you are thinking about new products … don’t forget about the FDA!

• When CMS; the pricing, data analysis, and coding contractor; or anyone else talks about what should be in your labeling … don’t forget about the FDA!

• When you think about whether CMS should consider your product as an OTS orthotic device … don’t forget about the FDA!

Finally, how did you do on the FDA quiz? Here are the answers to those five questions we started with:

ANSWERS/COMMENTARYTRUE

FALSE

1. All O&P devices are Class I, and, therefore, GMPs do not apply to any manufacturer, distributor, or patient-care facility that might be inspected by FDA.

Most, but not all, O&P devices are Class I—a small number are Class II and Class III. Class I devices are subject to both premarket notification rules under Section 510(k) and GMPs. Many O&P devices have received exemptions from one or both of these rules. Consult 21 CFR, Section 890, to check for exemptions—but even if exempted from GMPs, the record-keeping and complaint files sections of GMPs virtually always are applicable and maintained in force.

2. FDA is required to notify you in advance to clear a date for inspection.

In the United States, FDA is entitled to conduct an inspection, unannounced, at any time of its choosing. You may ask the inspector to wait a brief period to allow your designated FDA contact person to return to the office to meet the inspector.

3. Devices that have qualified for exemption from the GMP/QSR regulations of 21 CFR, Part 820, are the only O&P devices that are completely exempted from the UDI rules.

Essentially, these GMP-/QSRexempt devices are, as a practical matter, the only devices to enjoy complete exemptions from UDI. The best treatment does apply to these devices that have qualified for exemption from the GMP/QSR regulations of 21 CFR, Part 820. Nonexempted

Class I devices must either display a UPC as a substitute or fully meet the compliance requirements of these FDA regulations.

4. An O&P patient-care facility that does not operate central fabrication facilities for others is not required to register with FDA.

This activity falls clearly within the exemption from registration under 21 CFR, Section 807.65(i), which exempts “personnel from a hospital, clinic, dental laboratory, orthotic, or prosthetic retail facility, whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device.” Therefore, this type of O&P facility is not required to register with FDA.

5. Any entity that serves as the initial U.S. distributor of imported medical devices can expect that FDA will hold it to the same responsibilities that would apply if it were the manufacturer of the device.

While not every FDA requirement for manufacturers would apply, many would indeed apply. Since there is no other entity under the jurisdiction of the United States, FDA largely looks to the initial U.S. distributor of an imported device to “stand in the shoes” of the manufacturer for many obligations, e.g., registration and listing of the device.

Thomas F. Fise, JD, is executive director of AOPA and publisher of O&P News.

This material is not intended, and should not be relied on, as legal advice. Readers should consult with their own counsel about the legal matters discussed here.

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