Regulatory Open Forum

My company has acquired an FDA 510(k) cleared medical device from another manufacturer - the transfer of this device was finalized end of February 2021.  My company wishes to begin marketing the transferred device in the US only, as soon as possible.

I reviewed the FDA Guidance for establishment registration and device listing, but I'm not totally clear on what is expected from the new manufacturer of a "transferred device":

• When is the establishment registration required for this device?
• Is a device listing required and if so when?
• Will I only need to fill out the required forms listed on the FDA Guidance, or is other additional documentation required?

 Thank you!

My company has acquired an FDA 510(k) cleared medical device from another manufacturer - the transfer of this device was finalized end of February 2021.  My company wishes to begin marketing the transferred device in the US only, as soon as possible.

I reviewed the FDA Guidance for establishment registration and device listing, but I'm not totally clear on what is expected from the new manufacturer of a "transferred device":

• When is the establishment registration required for this device?
• Is a device listing required and if so when?
• Will I only need to fill out the required forms listed on the FDA Guidance, or is other additional documentation required?

 Thank you!

My company has acquired an FDA 510(k) cleared medical device from another manufacturer - the transfer of this device was finalized end of February 2021.  My company wishes to begin marketing the transferred device in the US only, as soon as possible.

I reviewed the FDA Guidance for establishment registration and device listing, but I'm not totally clear on what is expected from the new manufacturer of a "transferred device":

• When is the establishment registration required for this device?
• Is a device listing required and if so when?
• Will I only need to fill out the required forms listed on the FDA Guidance, or is other additional documentation required?

 Thank you!

No worries Anon about anonymity; it's very common in the Forum, and for various good reasons.

Lots of folks grapple with the practical interpretation of 807.20(a); it can certainly be hard to decipher.  That said, it generally revolves around FDA's liberal interpretation of "manufacturing", which includes, but is not limited to, specification development.  Generally speaking, if a firm is actively engaged in any regulated GMP operation (like supplier/vendor selection), then the firm has likely exceeded the 807.20(a) threshold.  For example, I suggest that the agency would interpret even the planning of relabeling / repackaging to be a design and/or production planning activity, and thus within the boundaries of 807.20(a).

The 30-day timeline for initial registrations is governed by §807.22(a) entitled "Initial registration and listing", along with the formative preamble from 1977 where industry and agency worked to establish a reasonable timeline.  Note also that the timeline is the same for revisions of existing registrations/listings [see §807.22(b)(2)].  By experience I can say that these mean calendar days.  Oddly, I haven't been able to put my finger on specific agency narratives directly stating this interpretation; perhaps other Forum members can do so.  Note that, in other aspects of Part 807, the agency states "business days" when it means business days, further indicating that it is safe to interpret "30 days" as just that.  Remember also that the actual law / statutory requirement in section 510 of the FD&C Act states that the registration must happen "immediately".  Accordingly, part 807's regulatory promulgation of this as a 30-day requirement is not likely to mean 30 business days, as that wouldn't seem to meet the intent of the underlying law.

My company has acquired an FDA 510(k) cleared medical device from another manufacturer - the transfer of this device was finalized end of February 2021.  My company wishes to begin marketing the transferred device in the US only, as soon as possible.

I reviewed the FDA Guidance for establishment registration and device listing, but I'm not totally clear on what is expected from the new manufacturer of a "transferred device":

• When is the establishment registration required for this device?
• Is a device listing required and if so when?
• Will I only need to fill out the required forms listed on the FDA Guidance, or is other additional documentation required?

 Thank you!

No worries Anon about anonymity; it's very common in the Forum, and for various good reasons.

Lots of folks grapple with the practical interpretation of 807.20(a); it can certainly be hard to decipher.  That said, it generally revolves around FDA's liberal interpretation of "manufacturing", which includes, but is not limited to, specification development.  Generally speaking, if a firm is actively engaged in any regulated GMP operation (like supplier/vendor selection), then the firm has likely exceeded the 807.20(a) threshold.  For example, I suggest that the agency would interpret even the planning of relabeling / repackaging to be a design and/or production planning activity, and thus within the boundaries of 807.20(a).

The 30-day timeline for initial registrations is governed by §807.22(a) entitled "Initial registration and listing", along with the formative preamble from 1977 where industry and agency worked to establish a reasonable timeline.  Note also that the timeline is the same for revisions of existing registrations/listings [see §807.22(b)(2)].  By experience I can say that these mean calendar days.  Oddly, I haven't been able to put my finger on specific agency narratives directly stating this interpretation; perhaps other Forum members can do so.  Note that, in other aspects of Part 807, the agency states "business days" when it means business days, further indicating that it is safe to interpret "30 days" as just that.  Remember also that the actual law / statutory requirement in section 510 of the FD&C Act states that the registration must happen "immediately".  Accordingly, part 807's regulatory promulgation of this as a 30-day requirement is not likely to mean 30 business days, as that wouldn't seem to meet the intent of the underlying law.

My company has acquired an FDA 510(k) cleared medical device from another manufacturer - the transfer of this device was finalized end of February 2021.  My company wishes to begin marketing the transferred device in the US only, as soon as possible.

I reviewed the FDA Guidance for establishment registration and device listing, but I'm not totally clear on what is expected from the new manufacturer of a "transferred device":

• When is the establishment registration required for this device?
• Is a device listing required and if so when?
• Will I only need to fill out the required forms listed on the FDA Guidance, or is other additional documentation required?

 Thank you!

No worries Anon about anonymity; it's very common in the Forum, and for various good reasons.

Lots of folks grapple with the practical interpretation of 807.20(a); it can certainly be hard to decipher.  That said, it generally revolves around FDA's liberal interpretation of "manufacturing", which includes, but is not limited to, specification development.  Generally speaking, if a firm is actively engaged in any regulated GMP operation (like supplier/vendor selection), then the firm has likely exceeded the 807.20(a) threshold.  For example, I suggest that the agency would interpret even the planning of relabeling / repackaging to be a design and/or production planning activity, and thus within the boundaries of 807.20(a).

The 30-day timeline for initial registrations is governed by §807.22(a) entitled "Initial registration and listing", along with the formative preamble from 1977 where industry and agency worked to establish a reasonable timeline.  Note also that the timeline is the same for revisions of existing registrations/listings [see §807.22(b)(2)].  By experience I can say that these mean calendar days.  Oddly, I haven't been able to put my finger on specific agency narratives directly stating this interpretation; perhaps other Forum members can do so.  Note that, in other aspects of Part 807, the agency states "business days" when it means business days, further indicating that it is safe to interpret "30 days" as just that.  Remember also that the actual law / statutory requirement in section 510 of the FD&C Act states that the registration must happen "immediately".  Accordingly, part 807's regulatory promulgation of this as a 30-day requirement is not likely to mean 30 business days, as that wouldn't seem to meet the intent of the underlying law.

My company has acquired an FDA 510(k) cleared medical device from another manufacturer - the transfer of this device was finalized end of February 2021.  My company wishes to begin marketing the transferred device in the US only, as soon as possible.

I reviewed the FDA Guidance for establishment registration and device listing, but I'm not totally clear on what is expected from the new manufacturer of a "transferred device":

• When is the establishment registration required for this device?
• Is a device listing required and if so when?
• Will I only need to fill out the required forms listed on the FDA Guidance, or is other additional documentation required?

 Thank you!